GE Healthcare
Kvick Lab™ cross flow system
Operating Instructions
Original Instructions
Table of Contents
Table of Contents
1
Introduction .............................................................................. 5
1.1
1.2
1.3
1.4
1.5
1.6
2
Safety instructions................................................................. 19
2.1
2.2
2.3
2.4
3
7
Operation overview .............................................................................................. 43
Starting the instrument ...................................................................................... 43
The pump control system ................................................................................. 43
Maintenance ........................................................................... 51
5.1
5.2
5.3
5.4
5.5
5.6
6
Site requirements .................................................................................................. 25
Unpacking ................................................................................................................. 25
Moving and carrying the system ................................................................... 26
Connections ............................................................................................................. 26
Installing a cassette holder .............................................................................. 28
Installing cassettes in the holder ................................................................... 28
Spare parts and accessories ........................................................................... 41
Operation ................................................................................ 43
4.1
4.2
4.3
5
Safety precautions ............................................................................................... 19
Labels .......................................................................................................................... 22
Emergency procedures ...................................................................................... 23
Recycling procedures .......................................................................................... 24
Installation .............................................................................. 25
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4
Important user information ................................................................................. 6
Regulatory information ......................................................................................... 8
Instrument ................................................................................................................ 10
Flow path .................................................................................................................. 14
Kvick Lab cassette holder ................................................................................. 15
Cassettes ................................................................................................................... 16
General ....................................................................................................................... 51
User maintenance schedule ............................................................................ 51
Cleaning ..................................................................................................................... 51
Cleaning and storing cassettes ...................................................................... 52
Maintenance of the holder ............................................................................... 54
Replacement of fuses ......................................................................................... 55
Troubleshooting ..................................................................... 57
Reference information .......................................................... 63
7.1
7.2
7.3
7.4
Kvik Lab system specifications ....................................................................... 63
Chemical compatibility ....................................................................................... 66
Service and training ............................................................................................. 67
Ordering information ........................................................................................... 67
Kvick Lab Operating Instructions 28-9646-76 AA
3
Table of Contents
Appendix A ................................................................................... 69
A.1
A.2
4
Drawings ............................................................................................................ 69
Using the cartridge adaptor kit ............................................................... 72
Kvick Lab Operating Instructions 28-9646-76 AA
Introduction 1
1 Introduction
Purpose of the Operating
Instructions
The Operating Instructions provide you with the instructions needed to handle Kvick Lab
in a safe way.
Prerequisites
In order to operate Kvick Lab safely and according to the intended purpose the
following prerequisites must be met:
•
You should be acquainted with the use of general laboratory equipment and with
handling of biological materials.
•
You must read Chapter 2 Safety instructions‚ on page 19 of these Operating
Instructions.
•
The system should be installed according to the instructions in Chapter 3 of these
Operating Instructions.
In this chapter
This chapter contains important user information and a general description of Kvick Lab
and its intended use.
Kvick Lab Operating Instructions 28-9646-76 AA
5
1
1.1
Introduction
Important user information
1.1 Important user information
Read this before using the Kvick
Lab
All users must read the Safety Instructions in Chapter 2 of these Operating Instructions
before installing, using or maintaining the system.
Do not operate Kvick Lab in any other way than described in the user documentation. If
you do, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.
Intended use
The Kvick Lab cross flow system is intended for laboratory scale filtration of biological
solutions using membrane cassettes under the conditions stated in this user manual. If
you use the system and cassettes in a manner not specified by GE Healthcare, you may
impair the protection provided by the system and cassettes.
When using any laboratory, pilot-scale, or production cross flow equipment, the
potential exists for personal injury unless you follow established safety procedures.
When using GE Healthcare products, you should follow OSHA, federal, state, and local
safety regulations for equipment installation and operation. You should follow your
company’s safety regulations. You should follow the specific safety instructions
provided in this user manual and any original equipment manufacturer user manuals
provided with your system.
Only qualified personnel who are adequately trained and who understand the
operating instructions should install, operate, maintain, and inspect the Kvick Lab
system.
Safety notices
These Operating Instructions contain WARNINGS, CAUTIONS and NOTICES concerning
the use of the product, with meanings as defined below.
WARNING
WARNING indicates a hazardous situation which, if not avoided, could
result in death or serious injury. It is important not to proceed until all
stated conditions are met and clearly understood.
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Kvick Lab Operating Instructions 28-9646-76 AA
Introduction 1
Important user information 1.1
CAUTION
CAUTION indicates a hazardous situation which, if not avoided, could
result in minor or moderate injury. It is important not to proceed until all
stated conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid damage to
the product or other equipment.
Kvick Lab Operating Instructions 28-9646-76 AA
7
1
1.2
Introduction
Regulatory information
Notes and tips
Note: A Note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip:
A tip contains useful information that can improve or optimize your procedures.
1.2 Regulatory information
This section lists the directives and standards that are fulfilled by Kvick Lab.
Manufacturing information
Requirement
Content
Name and address of manufacturer
GE Healthcare Bio-Sciences AB,
Björkgatan 30, SE 751 84 Uppsala
Sweden
Name and ID of notified body
-
Place and date of declaration
Uppsala, Sweden, May 2009
Identity of person authorized to sign DoC
See EC Declaration of Conformity
CE Conformity
Directive
Title
2006/42/EC
Machinery Directive (MD)
2006/95/EC
Low Voltage Directive (LVD)
2004/108/EC
ElectroMagnetic Compatibility (EMC) Directive
International standards
8
Standard
Description
Notes
EN 61010-1,
IEC 61010-1,
CAN/CSA-C22.2 no.
61010-1
Safety requirements for electrical
equipment for measurement, control
and laboratory use
Kvick Lab Operating Instructions 28-9646-76 AA
Introduction 1
Regulatory information 1.2
Standard
Description
Notes
EN 61326-1
EMC emissions and immunity
requirements for measurement,
control and laboratory use
Harmonized with
2004/108/EC
EN-ISO
12100-1, 12100-2
Safety of machinery – Basic concepts,
general principles for design
Harmonized with
2006/42/EC
EN-ISO
14121-1, 14121-2
Safety of machinery – Principles of
risk assessment
Harmonized with
2006/42/EC
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the
instrument when it is:
•
used as a stand-alone unit, or
•
connected to other CE-marked instruments, or
•
connected to other products recommended or described in the user
documentation, and
•
used in the same state as it was delivered from GE Healthcare, except for
alterations described in the user documentation or explicitly authorized by GE
Healthcare.
Regulatory compliance of
connected equipment
Any equipment connected to Kvick Lab cross flow system should meet the safety
requirements of EN 61010-1/IEC61010-1 or relevant harmonized standards. Within the
European Union, connected equipment must be CE-marked.
Kvick Lab Operating Instructions 28-9646-76 AA
9
1
1.3
Introduction
Instrument
1.3 Instrument
The main components of a Kvick Lab cross flow system include:
•
Stainless steel, jacketed reservoir
•
Rotary lobe feed pump
•
Kvick Lab cassette holder
•
Valves
•
In-line pressure gauges
•
Fittings and piping
•
Torque wrench and socket
The following sections describe each component.
9
10
4
5
1
6
7
8
2
3
Figure 1-1. Kvick Lab cross flow system.
Table 1-1. .Parts in Figure 1-1.
10
Part
Description
1
Feed reservoir
2
Pump head
3
Drain valve
4
Kvick Lab cassette holder
Kvick Lab Operating Instructions 28-9646-76 AA
Introduction 1
Instrument 1.3
Part
Description
5
Retentate pressure gauge
6
Retentate valve
7
Pump cabinet
8
Pump controls
9
Feed pressure gauge (not visible in picture)
10
Permeate valve
Feed Reservoir
The feed reservoir holds your process solution, feeds the solution to the feed pump, and
collects the retentate stream. The feed reservoir's cover includes two inlet ports
enabling you to vent the reservoir and introduce buffer during diafiltration. The feed
reservoir's cooling-heating jacket enables you to control the temperature of the
solution in the reservoir. The reservoir holds 2.5 liters of feed solution and is constructed
of stainless steel. A clamp holds the reservoir cover in place.
Six inlet and outlet ports support the functions of the feed reservoir. The feed port
located on the bottom of the reservoir feeds the pump. The retentate port on the side
of the tank accepts the retentate flow. The inlet and outlet ports for the cooling-heating
jacket are located on the side of the reservoir and are supplied with standard pipe
threads for connecting your cooling-heating lines. The small port on the reservoir cover
enable you to attach a filter for sterile venting of the reservoir, and the large reservoir
cover port enables you to introduce feed solution or diafiltration solution into the
system.
All the process line ports use sanitary connectors for connections.
11
1
2
4
5
3
6
7
Figure 1-2. Kvick Lab stainless steel, jacketed feed reservoir.
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11
1
1.3
Introduction
Instrument
Table 1-2. Parts in Figure 1-2.
Part
Description
1
Vent port
2
Fill port
3
Cooling/heating water inlet
4
Clamp for reservoir cover
5
Cooling/heating water outlet
6
Retentate inlet
7
Feed outlet
Rotary lobe feed pump
The pump provides precise control over feed flow, provides low shear pumping, and is
easy to operate. An original equipment user manual is provided with the feed pump.
Read the feed pump user manual completely before operating the system.
The 230 volt European model includes a high-pressure cut-off safety switch that is
controlled by the feed line pressure gauge. If the feed pressure reaches 4 barg (60 psig),
the pump shuts down.
Kvick Lab cassette holder
Your Kvick Lab system includes a Kvick Lab cassette holder and user manual. The user
manual describes how to use and care for the holder and cassettes. Read the holder’s
user manual before operating the system.
The Kvick Lab holder simplifies operation with fewer parts and connections than other
types of cross flow filtration cassette holders.
The Kvick Lab holder can hold one to five Kvick Lab cassettes, each cassette having 0.11
2
2
2
2
2
2
m (1.2 ft ) of membrane surface area for a range of 0.11 m (1.2 ft ) to 0.55 m (6.25 ft ).
The cassette holder includes a stand with height-adjustable feet to level and stabilize
the cassette holder on the pump housing.
You can adjust the height of the holder by loosening the lock nut on the holder feet,
rotating the feet to adjust the height, then tightening the lock nut.
Valves
Four sanitary diaphragm valves mounted on the feed, permeate, retentate, and drain
lines enable you to control the operating flows and pressures.
The valve located at the feed pump outlet has one inlet port and two outlet ports. One
port directs the feed to drain, and the other port directs the feed to the cassette holder.
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Kvick Lab Operating Instructions 28-9646-76 AA
Introduction 1
Instrument 1.3
The flow path is controlled by the operator by opening or closing the valve flow control
handles.
Of the three remaining valves, one controls the permeate flow, one controls the
retentate flow, and one controls the flow of compressed air into the feed line when an
integrity tester is attached to the system.
Pressure gauges
The system includes two, 0 to 4 barg (0 to 60 psig), glycerin-filled, in-line, pressure
gauges to monitor feed and retentate pressure.
The feed pressure gauge on European models includes a transmitter. If the feed
pressure rises above 4 barg (60 psig), the signal from the transmitter triggers a safety
control circuit that shuts the pump down.
1.3.1 Fittings and piping
The system includes a number of stainless steel components, tubing, fittings, and
sanitary clamps that come pre-assembled. In addition to the assembled components,
the following parts are supplied with the system:
Two, 1/2-inch NPT-to-3/8-inch hose barb fittings—screw these into the heating jacket
ports so that you can attach heating/ cooling water tubing to the reservoir jacket.
Two, 24-inch-long pieces of 3/8-inch ID tubing and three clamps—attach one piece of
tubing to the permeate hose barb and secure with a clamp. Direct the other end of the
tubing to either a drain, collection vessel, or the feed reservoir inlet, depending upon the
application. Attach the other piece of tubing to the feed-line hose barb and secure with
a clamp. Direct and attach the other end of the line to an integrity tester if needed.
One, 1/2-inch sanitary cap—use this cap and a user-supplied sanitary clamp to blank
off any 1/2-inch sanitary fitting, such as the feed line drain valve fitting.
One, vortex diverter—the vortex diverter is a square piece of metal placed at the bottom
of the feed reservoir to prevent the formation of a vortex.
You can purchase additional piping, fittings, and clamps through your local GE
Healthcare representative.
Torque wrench and socket
The system includes a torque wrench, a 9/16-inch socket for precise tightening of the
cassette holder tie rod nuts, and a user manual. Read the torque wrench user manual
before clamping the cassettes in the cassette holder.
Kvick Lab Operating Instructions 28-9646-76 AA
13
1
1.4
Introduction
Flow path
1.4 Flow path
The standard flowpath for the Kvick Lab system enables you to complete many cross
flow processes.
10
4
14
11
12
5
1
15
8
2
8
6
5
16
3
8
13
9
7
Figure 1-3. Kvick Lab cross flow system flow diagram.
Table 1-3. Parts in Figure 1-3.
14
Part
Description
1
Kvick Lab cassette holder
2
Retentate line
3
Feed line
4
Cooling /Heating connection for jacket
5
Pressure gauge
6
Permeate line
7
Collection vessel
8
Valve
9
Drain line
Kvick Lab Operating Instructions 28-9646-76 AA
Introduction 1
Kvick Lab cassette holder 1.5
Part
Description
10
Vent port
11
Feed reservoir
12
Cooling/Heating jacket
13
Pump
14
Diafiltration (solution) feed line
15
Cooling/Heating water
16
Double valve
1.5 Kvick Lab cassette holder
The Kvick Lab cassette holder is designed to hold 1 to 5 Kvick Lab cassettes. Together,
the holder and the cassettes enable you to separate, concentrate, and diafiltrate
biological solutions with precision. For example, you can complete ultrafiltration at
laboratory scale volumes (starting volumes of less than 1 liter).
Figure 1-4. Kvick Lab cassette holder.
Table 1-4. Parts in Figure 1-4.
Part
Description
1
Flow distribution plate
2
Back plate
Kvick Lab Operating Instructions 28-9646-76 AA
15
1
1.6
Introduction
Cassettes
Part
Description
3
Spacers
4
Washer
5
Nut
6
Guide rod
7
Stand
8
Retentate port
9
Permeate port
10
Feed port
11
Tie rod
1.6 Cassettes
The two sizes of Kvick Lab cassettes share design components, including inlet and
outlet ports, labeling, and alignment notches (Figure 1-5).
Figure 1-5. Cassette.
Table 1-5. Parts in Figure 1-5.
16
Part
Description
1
Feed port
2
Retentate port
3
Permeate port
4
Cassette information
5
Alignment notches
6
Incorporated gasket
Kvick Lab Operating Instructions 28-9646-76 AA
Safety instructions 2
Safety precautions 2.1
2 Safety instructions
This chapter describes safety compliance, safety labels, general safety precautions,
emergency procedures, power failure and recycling of Kvick Lab.
2.1 Safety precautions
Introduction
Before installing, operating of maintaining the system, you must be aware of the
hazards described in the user documentation. Follow the instructions provided to avoid
personal injury or damage to the equipment.
The safety precautions in this section are grouped into the following categories:
•
General precautions
•
Flammable liquids
•
Personal protection
•
Installing and moving the instrument
•
Maintenance
Kvick Lab Operating Instructions 28-9646-76 AA
19
2
2.1
Safety instructions
Safety precautions
General precautions
WARNING
If you overpressurize the system with compressed air during integrity
testing, system components can rupture causing bodily harm. To avoid
the rupture of a system component due to over pressurization with
compressed air, use a pressure regulator to limit the pressure of your
compressed air supply to the maximum operating pressure of your
system.
WARNING
Wear the appropriate personal protection devices when testing and
using the system.
WARNING
If the system leaks, it can release potentially hazardous process fluids or
cleaning fluids causing bodily harm. To prevent leaks and the release of
potentially hazardous process or cleaning fluids, limit feed pressure to 3
barg (45 psi), periodically check parts for wear, and ensure you assemble
the components correctly.
Notices
NOTICE
Failure to carefully plan the installation of the system can result in
equipment damage or poor performance. To avoid equipment damage,
carefully plan the installation of the system in reference to the effects of
a power failure and utility connections. Read the installation instructions
in the system’s Operating Instructions.
NOTICE
Hollow fiber cartridges are strong and safe, but mishandling can
damage the membrane fibers or cartridge housing connectors. Follow
guidelines in Operations section to prevent damage to the hollow fibers
and cartridge housing connectors.
NOTICE
If you operate the pump dry (without any process fluid in it), you can
damage the pump. To prevent damage to the pump, ensure that fluid is
present in the reservoir and feed line whenever you run the pump.
20
Kvick Lab Operating Instructions 28-9646-76 AA
Safety instructions 2
Safety precautions 2.1
Using flammable liquids
WARNING
An adequately dimensioned ventilation system shall be installed when
flammable or noxious substances are used.
Personal protection
WARNING
Wear the appropriate personal protection devices and clothing when
operating and cleaning the system. Basic personal protection devices
include protective clothing, safety glasses, and hearing protection. Use
additional protective devices (fume hood, respirator, etc.) if the nature of
your product or your company’s safety regulations require it.
WARNING
Wear hearing protection when operating the system at high speeds for
extended periods of time.
WARNING
Wear protective glasses at all times when in vicinity of instrument.
Installing and moving the
instrument
WARNING
Use tubing clamps on all hose barb connections, particularly
connections to the feed ports for leak-free connections at high pressure.
Failure to do so may lead to unexpected leaks that my lead to bodily
harm.
WARNING
The instrument must be connected to a grounded mains socket.
WARNING
Do not block the rear panel of the system. The mains power switch must
always be easy to access.
Kvick Lab Operating Instructions 28-9646-76 AA
21
2
2.2
Safety instructions
Labels
CAUTION
Cassette holders are heavy. The weight of cassette holders requires that
you carry them properly and support them well, especially when
integrated into a cross-flow system. To avoid bodily injury or equipment
damage from a falling cassette holder, ensure you have a secure,
controlled grip and a sufficient number of people or the proper
equipment to move it. Wear safety shoes. Ensure the holder and piping
are properly supported and that piping supports meet local safety
codes.
System operation
WARNING
Ensure that the retentate valve is open before starting the feed pump.
Failure to do so can cause the feed pressure to reach excessively high
levels causing leaks, bodily harm, and damage to the cartridge.
WARNING
If you place a finger in the inlet or outlet port of the pump, your finger
can reach the pump rotors. Hence, if the pump starts or is running while
you place a finger into the pump inlet or outlet, bodily harm will result.
To prevent bodily harm, never place fingers in the inlet or outlet ports of
the pump.
Maintenance
WARNING
Disconnect the power cable, the compressed air supply, and
decompress the system before inspecting or maintaining the system.
Failure to do so can result in bodily harm from the accidental starting of
the pump or unexpected release of pressure.
WARNING
Decontaminate the equipment before decommissioning to ensure the
removal of all hazardous residues.
2.2 Labels
This section describes safety labels and labels concerning hazardous substances that
are attached to the Kvick Lab.
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Kvick Lab Operating Instructions 28-9646-76 AA
Safety instructions 2
Emergency procedures 2.3
Labels on the instrument
The pump label, located on the back of the pump housing, provides key identification
and specification information (Figure 2-1). The CE mark for European models is located
on the lower left-hand side of the back panel. The Kvick Lab label is shown in Fig 2-2.
Figure 2-1. Typical pump label.
XX-XXXX-XX
Code No:
Serial No
Mfg Year:
Kvick Lab
XXXXXXXX
XXXXXXX
2009
N12406
Made in Sweden GE Healthcare Bio-Sciences AB
751 84 Uppsala Sweden
Figure 2-2. Example of Kvick Lab marking label.
2.3 Emergency procedures
This section describes how to do an emergency shut down of the Kvick Lab system. The
section also describes the result in the event of power failure.
Emergency procedures
In an emergency situation, do as follows to stop the run:
Press the Stop button on pump control panel.
Kvick Lab Operating Instructions 28-9646-76 AA
23
2
2.4
Safety instructions
Recycling procedures
Power failure
In the event of a power failure:
1
Unplug the system from the mains power receptacle until the power is restored.
2
Drain the system reservoir to recover as much process fluid as possible.
2.4 Recycling procedures
The equipment shall be decontaminated before decommissioning and all local
regulations shall be followed with regard to scrapping of the equipment.
Disposal, general instructions
When taking Kvick Lab out of service, the different materials must be separated and
recycled according to national and local environmental regulations.
Recycling of hazardous
substances
Kvick Lab contains hazardous substances. Detailed information is available from your
local GE Healthcare representative.
Disposal of electrical
components
Waste of electrical and electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately. Please contact an authorized
representative of the manufacturer for information concerning the decommissioning of
your equipment.
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Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Site requirements 3.1
3 Installation
3.1 Site requirements
To set up your system you must choose a location, move the system to the location, and
make several utility connections.
Choosing a location
Select a location that includes:
• appropriate drains or collection vessels to collect waste and processed fluids
•
electrical power supply
•
instrument-quality compressed air if needed for customer-supplied integrity test
equipment
•
a supply of cooling/heating water and a system to pump it through the cooling/
heating jacket if needed
•
sufficient room to perform maintenance on the system.
Table 3-1. Electrical and environmental requirements.
Parameter
Requirement
Voltage*
104-126 VAC, 200-230 VAC, 50/60 Hz
Current
2.2 to 4.5 A
Placement
On sturdy laboratory bench
Ambient temperature
25ºC maximum
*Not suitable to Ground Fault Circuit Interrupt circuitry with 30mA breakers. Use unprotected
mains to avoid nuisance tripping of breakers.
3.2 Unpacking
Your Kvick Lab system arrives assembled and packaged in a wooden crate. The wooden
crate includes these components:
•
Kvick Lab system including a Kvick Lab cassette holder and rotary lobe pump
•
Torque wrench and socket
Kvick Lab Operating Instructions 28-9646-76 AA
25
3
3.3
Installation
Moving and carrying the system
•
Torque wrench OEM user guide
•
Rotary lobe pump OEM user guide
To unpack the system, place the crate on the ground.
Remove the five bolts located along the bottom edge of the crate.
With an assistant, slide the cover (top and sides) up off the base. Remove the foam
surrounding the system.
After unpacking do the following:
•
Check the equipment for any apparent damage before starting installation.
•
Document any damage carefully and contact your GE Healthcare representative.
3.3 Moving and carrying the system
CAUTION
The system weighs about 80 kg (175 lbs). At least four people or a lifting
device are required when lifting the equipment. Failure to follow this
instruction may lead to strain or injury.
After unpacking, you must lift and move the system to the operating location. The
system weighs about 80 kilograms (175 pounds). Therefore you should:
•
get help from at least 3 assistants to ensure safe, controlled lifting,
•
use a sturdy cart to transport the system, and
•
wear gloves to protect your hands. When lifting the system, support it from the
pump head and the pump housing, not from the reservoir, cassette holder, or
piping.
Transport and lift the system onto a sturdy laboratory bench or other work table. Ensure
the system is stable and level.
3.4 Connections
Process lines
Connect a drain line to the drain port of the feed/drain valve using a 1.2-inch sanitary
connector fitting, gasket, and clamp. (Attaching a flexible drain line to the port will
enable you to move the drain line between various collection vessels or a drain.)
26
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Connections 3.4
Electrical connections
Connect the Kvick Lab system power cord to an electrical outlet of the proper voltage.
You can determine the voltage requirements of your system by reading the label
located on the back of the pump housing. The electrical supply circuit should be fuseWARNING
The instrument must be connected to a grounded mains socket.
protected, but the system will not work if the supply circuit is protected with a ground
fault circuit interrupt. (A ground fault circuit interrupt is already included in the pump’s
inverter.)
Compressed air connections
If you will be using an integrity tester to document the proper performance of your
cassettes, cassette holder, and system piping, ensure you have a supply of instrumentquality compressed air. The air supply should include a pressure regulator to limit
incoming air pressure to 3 bar g (45 psi g).
Connect the instrument quality air to your integrity tester.
Connect the air output from your integrity tester to the 3/8-inch hose barb located in
the system’s feed line. Make the connection using 3/8-inch ID compressed air tubing
and hose clamps.
Tip:
Expert users normally check their cross flow systems for leaks by pressurizing the
system with compressed air and observing any loss in air pressure over time.
Expert users also check the integrity of cassettes before using them by
pressurizing the system and measuring the diffusion of air through the cassettes.
If the diffusion rate meets known standards, then the user is assured that the
cassettes do not contain pinholes and are securely mounted in the cassette
holder. GE Healthcare recommends that you use or purchase an integrity tester
and test your system and cassettes before use following the procedure described
Cooling and heating water
If you plan to use the cooling and heating jacket to control product temperature in the
feed reservoir, you will need a system to supply or circulate cooling and heating fluid
through the cooling jacket.
The inlet and outlet ports for the cooling/heating jacket are located on the side of the
reservoir. The inlet port is closest to the bottom of the reservoir, and the outlet port is
located closer to the top of the reservoir. Attach the two 1/2-inch NPT-to-3/8-inch hose
barb fittings supplied with the system to the inlet and outlet ports.
Attach 3/8-inch ID heating/cooling lines to the hose barbs and secure with hose clamps.
Set up your heating/cooling system to circulate fluid through the reservoir heating/
cooling jacket. See Figure 1-2 for location of connections.
Kvick Lab Operating Instructions 28-9646-76 AA
27
3
3.5
Installation
Installing a cassette holder
3.5 Installing a cassette holder
Gather the following materials to install your GE Healthcare cassette holder into your
cross-flow system:
• A cross-flow system including a feed reservoir, feed pump, a minimum of two glycerinfilled pressure gauges, and three flow control valves
• System piping and fittings to connect the feed pump, permeate collection vessel, and
feed reservoir to the holder. The system piping must end in 1/2-inch sanitary clamps to
connect to the Kvick Lab holder.
• Three, fractional sanitary clamps and 1/2-inch gaskets
Making the connections
Place the Kvick Lab holder on the pump as shown in Figure 1-1. Stabilize and level the
holder using the adjustable feet. Keep piping runs short to minimize holdup volume.
Connect the holder’s feed, retentate, and permeate ports to your system’s piping using
the three gaskets and sanitary clamp.
To install a cassette in your holder, place the cassette and a gasket in the holder and
clamp them in place using the tie rod spacers and nuts. You must tighten the nuts to
torque of 20.3 Nm (180in-lbs) to ensure the proper clamping force is applied to seal the
cassette in place.
Final checks
Before using the system, check the cassette holder to ensure it sits squarely on the
pump housing and is not producing strain on the system piping. Finally, check the
tightness of all sanitary clamps.
3.6 Installing cassettes in the holder
To install a cassette in your holder, place the cassette and a gasket in the holder and
clamp them in place using the tie rod spacers and nuts. You must tighten the nuts to a
torque of 20.3 Nm to ensure the proper clamping force is applied to seal the cassette in
place.
Determining how many
cassettes you can install
The Kvick Lab holder can hold multiple cassettes depending upon the cassette type and
the membrane area your application requires (Table 3-2).
Table 3-2. Cassette installation guide for the Kvick Lab cassette holder.
28
Cassette type
Cassette size
No. of cassettes
(install)
Nut torque
Kvick Lab packet
100 cm² (0.11 ft²)
1 to 10
13.5 Nm (120 in-lb)
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
Cassette type
Cassette size
No. of cassettes
(install)
Nut torque
Kvick Lab
0.11 m² (1.2 ft²)
1 to 5
20.3 Nm (180 in-lb)
Installing the cassettes
Follow these steps to install cassettes in Kvick Lab cassette holders:
1
Remove the tie rod nuts, washers, and spacers. Slide the back plate away from the
flow distribution manifold (Figure 1-4).
2
To install one cassette:
3
a)
Clean and wet a silicone gasket by rinsing it with DI water or water-forinjection (WFI).
b)
Place the gasket against the flow distribution manifold, aligning the holes in
the gasket with the holes in the manifold. The gasket will stick to the manifold.
c)
Place the cassette into the holder with the gasket- side of the cassette facing
the backing plate, and slide the cassette against the gasket.
To install two or more cassettes:
a)
Complete the step above for installing one cassette.
b)
Place the second cassette into the holder between the first cassette and the
backing plate. Ensure the gasket-side of the second cassette faces the
ungasketed side of the first cassette.
c)
Place subsequent cassettes in the holder in a similar fashion.
4
Slide the backing plate forward to hold the cassettes in the hardware, ensuring the
holes in the manifold, gasket, and cassettes line up.
5
Add spacers to the tie rods until about 0.75-inches (16mm) of thread is exposed on
each tie rod. Reinstall the washers and nuts. Finger tighten the nuts evenly.
6
Tighten each nut alternately 1/4 turn at a time with the supplied torque wrench
and socket until each nut is tightened to 20.3 Nm (180 in-lbs). If a seal is not
achieved, there may be a cassette, gasket, or surface finish irregularity.
Discontinue torque tightening and inspect the sealing surfaces.
To learn how to use the torque wrench, consult the torque wrench user’s guide.
Tip:
The nut torque values are based on the tie rod threads being dry. You should not
oil the tie rod threads. Oiled tie rod threads will result in too much clamping
pressure being applied to the cassette.
Tip:
The nut torque values in the above procedure are based on the holder and
cassette being at 18 to 23°C (64 to 74 °F). Lower or higher temperatures
Kvick Lab Operating Instructions 28-9646-76 AA
29
3
3.6
Installation
Installing cassettes in the holder
experienced during processing and cleaning can change the clamping force
applied to the cassette (due to expansion and contraction of the holder and
cassette). Increases in temperature, in particular, can damage cassettes.
Therefore, you should periodically check the nut torque. If the nut torque is too
high, excessive clamping force can damage the cassette. If the nut torque is too
low, insufficient clamping force can cause leaks or give false integrity test results.
Before using a new Kvick Lab cassette, you must flush it with DI water or WFI to remove
the storage solution. Many applications require that you complete several of the other
preparatory stages listed below to ensure the cassette and the holder perform properly
and consistently:
Rinse Storage Solution from the Cassette—before using a new cassette—or a used one
that you cleaned and stored—you must flush the storage solution from the cassette.
Determine the Water Flux—you determine the water flux by measuring water flow
through the cassette’s membrane under controlled process conditions. By measuring
the water flow before and after cleaning, you can determine cleaning effectiveness and
monitor the cassette’s performance.
Test the Integrity of the Cassette—in this two-part process, you check the system and
cassette for leaks or damage to the membrane.
Sanitize the Cassette—when you require sanitary processing conditions, you can
sanitize the cassette with sanitizing agents.
Condition the System with Buffer— conditioning exposes your crossflow system’s
wetted parts to an appropriate buffer before you introduce your product to the system.
The conditioning minimizes unwanted chemical reactions between your product and
the wetted parts. The buffer can also bring the system to the proper operating
temperature before processing begins.
Tip:
30
Expert users normally establish pump curves for the system configuration they
plan to use. By establishing a pump curve, they can quickly and accurately set the
pump speed to achieve the recommended flow rate during processing. To
determine the flow rate without a pump curve, you would have to disconnect the
retentate line and measure the flow rate using a graduated cylinder and stop
watch. If you need help in developing a pump curve, contact GE Healthcare
technical support team.
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
Stage 1-Rinse storage solution
from the cassette
Opening the cassette bag safely
WARNING
The cassette and cassette bag contains an aqueous solution containing
0.1 to 0.2 N NaOH and 20 to 22% glycerin by weight. When opening the
cassette bag, follow the standard safety procedures for handling
aqueous NaOH, including the use of safety glasses, safety gloves, and
protective lab coat. To avoid unexpected spilling, hold the cassette
package upright over a sink and trim the top of the cassette bag with
scissors. Drain and dispose of the excess storage solution in accordance
with environmental regulations. To avoid inadvertent contact with the
storage solution after the cassette is removed from the bag, rinse the
outside surface of the cassette with high purity water.
If you allow an ultrafiltration cassette to dry out, the membrane will be damaged.
Therefore, do not store the cassette without rewetting it with an approved storage
solution.
At a minimum, before using a new or used-and-stored cassette, rinse the storage
solution from the cassette following these steps:
1
Open the cassette bag and remove the cassette following the safety instructions
above.
2
Install the cassette in the cassette holder. (See your cassette holder’s user guide for
specific installation instructions.)
3
Configure the system so that the retentate and permeate lines discharge to waste
(Figure 3-1). Close the feed, retentate, and permeate valves.
4
Fill the reservoir with an appropriate volume of clean water (6 liters per 0.11 m² [1.2
ft²] cassette).
5
Open the feed and retentate valves and close the permeate valve. Pump about 10
percent of the water through the retentate line to waste, maintaining a feed
pressure of 0.35 barg (5 psig).
NOTICE
Using tap water to flush or rinse cassettes can plug the pores of
membrane with the relatively large particulates (rust, dirt, minerals,
bacteria, etc.) found in tap water. To prevent plugging the pores of the
cassette, always use 0.2 µm filtered water or water-for-injection when
rinsing or flushing the cassette, or when making up cleaning solutions or
adding dilution water to process fluids.
Kvick Lab Operating Instructions 28-9646-76 AA
31
3
3.6
Installation
Installing cassettes in the holder
4
1
3
2
5
6
7
8
10
9
Figure 3-1. Typical setup for rinsing cassettes.
Table 3-3. Parts in Figure 3-1.
Part
Description
Part
Description
1
Feed reservoir
6
Kvick Lab holder
2
Waste
7
Permeate
3
Valve
8
Pump
4
Pressure gauge
9
Drain line
5
Retentate
10
Feed
6
Open the permeate valve and close the retentate valve and pump the remaining
water through the permeate line to waste, maintaining a feed pressure of 0.35 barg
(5 psig).
7
If needed for your application, sample and analyze the last volume of drain water
pumped from the system for traces of storage or cleaning solution. Repeat steps 4
through 7 until you achieve the needed level of storage solution removal.
8
If needed, circulate buffer to prepare the cassette and system for processing.
Stage 2—Measuring water flux
Measuring water flux involves measuring the flow of water through the cassette’s
membrane under controlled conditions.
You convert the measurement into units that represent water flux.
The water flux value you obtain provides an indicator of the performance of the
cassette. GE Healthcare recommends that you measure water flux when the cassette
is new and before each use. By tracking the water flux measurements, you can; (1)
32
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
determine the effectiveness of cleaning cycles, and (2) determine when cassette
reaches the end of its service life.
Measuring water flux manually requires about 30 minutes and this equipment:
graduated cylinder, stopwatch, thermometer, calculator, pen and paper. If you have a
flow meter installed on the permeate line, you can use the flow meter for measuring
flux.
Summary of water flux measurement procedure
The following steps summarize how to measure water flux:
1
Measure the water flow from the permeate port at two transmembrane pressures.
2
Calculate water flux in l/m²/hr (LMH) for the two water flow measurements.
3
Plot the two flux values. Then interpolate Kvick Lab cassette water flux at 0.7 barg
(10 psig) transmembrane pressure.
4
Normalize the water flux value to 20°C and 1 psig to arrive at flux in LMH/psig @
20°C.
5
Record the flux value as a benchmark for future comparison. Compare the flux with
previously obtained values.
The following text describes how to complete each step.
Measure flow from the permeate port
Follow these steps to measure the water flow rate from the permeate port:
1
Rinse the cassette following the instructions in Stage 1—Rinse the Kvick Lab
cassette.
2
Setup your crossflow system to circulate the retentate and permeate back to the
feed reservoir (Figure 3-2).
3
Fill the feed reservoir with a volume of deionized water or WFI. Fully open the feed,
retentate, and permeate valves.
4
Start the feed pump and adjust it and the retentate valve to obtain a
transmembrane pressure of 0.3 barg (5 psig). Using a graduated cylinder and stop
watch, measure and record the permeate flow rate in ml/min. Record the
temperature of the water in the feed reservoir.
5
Adjust the feed pump and retentate valve to produce a transmembrane pressure
of 1 barg (15 psig). Using a graduated cylinder and stop watch, measure and record
the permeate flow rate in ml/min. Record the temperature of the water in the feed
reservoir.
6
Drain the system.
Kvick Lab Operating Instructions 28-9646-76 AA
33
3
3.6
Installation
Installing cassettes in the holder
3
1
2
4
6
12
5
9
7
10
8
11
Figure 3-2. Typical configuration for measuring water flux.
Table 3-4. Parts in Figure 3-2.
Part
Description
1
Feed reservoir
2
Valve
3
Pressure gauge
4
Retentate
5
Kvick Lab holder
6
Permeate
7
Pump
8
Drain line
9
Feed
10
Optional flow meter
11
Graduated cylinder
12
Pressure gauge
Calculate flux in l/m²/hr
Convert the permeate flow rate (l/min.) measurements to flux using this equation:
34
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
Flux in LMH (l/m²/hr) = permeate flow in ml/min ÷ cassette surface area in square
meters × 60
Plot flux and determine flux at 0.7 barg
Plot the calculated flux values against the transmembrane pressure (Figure 3-3).
Determine the water flux in LMH at 0.7 barg (10psig). In Figure 3-3, the flux at 0.7 barg
(10 psig) is 115 LMH.
200
F l ux ( L M H )
150
100
50
5
10
15
20
25
Transmembrane Pressure (PSIG)
Figure 3-3. Plot of water flux versus transmembrane pressure.
Normalize water flux to 20°C and 1 psig
Follow these steps to normalize the water flux value to 20°C and standardize to 1 psig
to arrive at flux in LMH/psig at 20°C:
Multiply the calculated flux value by the appropriate viscosity correction factor in Table
For example, if the flux at 0.7 barg (10 psig) is 115 LMH, and the temperature of the
water during permeate flow measurement was 18°C, then the flux normalized to 20°C
is:
115 LMH x 1.053 = 121 LMH/10 psig
To standardize the flux value to 1 psig, divide the normalized water flux value by 10 psig.
For example, 121 LMH ÷ 10 = 12.1 LMH/psig
Record the flux value
Record the normalized flux value in your laboratory notebook or production records as
a benchmark for future comparison. If the cassette is used, compare the flux with
previously obtained values to determine the performance of the cassette over time.
Many users replace cassettes when, after cleaning, the normalized water flux falls
below 60 to 80 percent of the normalized flux value when the cassette was new.
If after cleaning, the flux is low, you can try alternative, aggressive cleaning processes.
Contact GE Healthcare for more information.
Kvick Lab Operating Instructions 28-9646-76 AA
35
3
3.6
Installation
Installing cassettes in the holder
Table 3-5. Viscosity correction factors.
Temperature in
ºC when permeate flow was
measured
Viscosity
correction factor
Temperature in
ºC when permeate flow was
measured
Viscosity
correction factor
4
1.567
25
0.890
5
1.519
26
0.871
6
1.472
27
0.851
7
1.428
28
0.833
8
1.386
29
0.815
9
1.346
30
0.798
10
1.307
31
0.781
11
1.271
32
0.765
12
1.235
33
0.749
13
1.202
34
0.734
14
1.169
35
0.719
15
1.139
36
0.705
16
1.109
37
0.692
17
1.081
38
0.678
18
1.053
39
0.665
19
1.027
40
0.653
20
1.000
41
0.641
21
0.978
42
0.629
22
0.955
43
0.618
23
0.933
44
0.607
24
0.911
45
0.597
Stage 3—Test the integrity of
the cassette
Before using your cross-flow system and cassette to process product, test the crossflow system to ensure it does not leak. Then test the integrity of the cassette.
36
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
To test your cross-flow system for leaks, pressurize it with water and check the tubing
or piping connections for leaks. To test the integrity of the cassette, pressurize the
system with compressed air and measure the diffusional flow of air through the
cassette membrane. A high flow rate (above the cassette’s specification) indicates
there might be a hole or tear in the membrane.
Follow the instructions below to test the system for leaks, and to test the integrity of the
cassette.
Test your system for leaks
To test your cross-flow system for leaks, fill the system with clean water. Open the feed
valve. Open the retentate valve. Close the permeate valve. Start the feed pump on slow
speed and throttle the retentate valve until the feed pressure reads 3 barg (45 psig).
Check all connections for leaks.
Test the integrity of the cassette
To measure diffusional air flow through the membrane via the permeate port, you will
need to add a compressed air line, pressure regulator, and cut-off valve to your crossflow system. You also need the following equipment: a 500-ml beaker, 50-ml graduated
cylinder, stopwatch, and a piece of flexible tubing (Figure 3-4).
Test the integrity of the system and cassette manually by following the procedure
described below.
2
1
3
4
5
6
7
8
10
11
9
12
13
14
15
16
Figure 3-4. Flow diagram for testing a crossflow system and cassette before use.
Kvick Lab Operating Instructions 28-9646-76 AA
37
3
3.6
Installation
Installing cassettes in the holder
Table 3-6. Parts in Figure 3-5.
Part
Description
Part
Description
1
Flexible tubing connected
from permeate line and
inserted into mouth of
inverted graduated cylinder
2
Inverted graduated cylinder
filled with water
3
Beaker filled with water
4
Feed reservoir
5
Waste
6
Valve
7
Pressure gauge
8
Retentate
9
Kvick Lab cassette
10
Permeate
11
Pump
12
Feed
13
Drain line
14
Air shutoff valve
15
Pressure regulator
16
Instrument quality
compressed air
Check the integrity of the cassette
When you establish that the system is leak-free, test the integrity of the Kvick Lab
cassette by following these steps.
38
1
Ensure the compressed air valve is closed and the pressure regulator is set to 0
barg (0 psig). Close the feed and drain valves, and open the retentate and permeate
valves.
2
Remove water from the cassette feed-retentate path by opening the compressed
air valve, and slowly adjusting the pressure regulator to 0.3 barg (5 psig). Flow air
through the system until water stops draining from the retentate line. Close the
retentate valve to allow the air pressure to drive the water from the permeate port
and permeate line.
3
Slowly adjust the pressure regulator to 1 barg (15 psig).
4
Fill a 50-ml graduated cylinder with water and place it inverted in a 500-ml beaker
half filled with water. Connect flexible tubing to the permeate outlet (Figure 3-4).
5
When the air bubble rate is stable, note the time and the standing air volume in the
graduated cylinder. When 5 to 10 ml of air has collected in the graduate cylinder,
record the time and air volume again.
6
Using the time and air volume data, calculate the air diffusion rate in ml/min/ft² @
1 barg (15 psig).
7
Compare your results with the specifications below. If your measured flow rate is
less than the specification, the Kvick Lab cassette is acceptable for use. The
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
specifications are:
10 ml/min/Kvick Lab cassette at 1 barg for 10K and 10KS cassettes.
8
When the Kvick Lab cassette passes integrity testing, you can sanitize it (Stage 4),
condition it with buffer (Stage 5), or process product as required.
9
If the Kvick Lab cassette fails the integrity test, contact your GE Healthcare
representative for help.
Stage 4- Sanitizing the Kvick Lab
cassette
Clean and rinse the Kvick Lab cassette, then follow these steps to sanitize the cassette:
1
Configure the system so that the retentate and permeate lines discharge into the
feed reservoir (Figure 3-5). Close the drain valve.
2
Fill the feed reservoir with 1.5 to 2 liters of 0.1 N sodium hydroxide for each cassette
in your system. The temperature of the solution should be 35 to 45°C.
3
Open the feed, retentate, and permeate valves. Start the pump. Adjust the
retentate valve and pump speed to obtain a retentate pressure of 0.7 barg (10 psig)
and the following retentate flow rate: 875 ml/min for each 0.11 m² (1.2 ft²) Kvick Lab
cassette installed.
4
Circulate the sanitizing solution for minimum of 60 minutes at a temperature of 35
to 45°C. Stop the pump. If you are going to store the Kvick Lab cassette, rinse and
add storage solution as described on page 52.
Kvick Lab Operating Instructions 28-9646-76 AA
39
3
3.6
Installation
Installing cassettes in the holder
5
If you are sanitizing the Kvick Lab cassette before use, drain the sanitizing solution
from the system and then rinse the Kvick Lab cassette following the rinsing
procedure on page 31.
1
3
2
4
5
7
6
8
9
Figure 3-5. Typical setup for sanitizing a Kvick Lab cassette and system.
Table 3-7. Parts in Figure 3-5.
Part
Description
Part
Description
1
Feed reservoir
2
Valve
3
Pressure gauge
4
Retentate
5
Kvick Lab cassette
6
Pump
7
Permeate
8
Feed
9
Drain line
-
-
Stage 5—Conditioning the
system with buffer
Before processing your sample, precondition the cross-flow system with a buffer similar
in pH and ionic strength to that of your sample. Conditioning the system removes
trapped air and minimizes unwanted chemical reactions between your sample and the
wetted parts of the cross-flow system. You can also use buffer conditioning to stabilize
the temperature of the cross-flow system.
Follow these steps to condition the system with buffer:
40
Kvick Lab Operating Instructions 28-9646-76 AA
Installation 3
Installing cassettes in the holder 3.6
1
Setup your cross-flow system to circulate the retentate and permeate back to the
feed reservoir (Figure 3-6).
2
Prepare the buffer solution, and if necessary, condition it to the proper
temperature. The recommended volume of buffer solution is 1 liter per cassette.
3
Put the buffer in the feed reservoir. Open the feed, retentate, and permeate valves.
Start the feed pump and increase the feed rate until solution flows from the
retentate and permeate lines.
4
Close the retentate valve to produce about 0.3 to 1 barg (5 to 15 psig) of retentate
pressure. Run until no bubbles appear in the permeate stream.
5
Open the retentate valve and close the permeate valve. Increase the retentate flow
rate to the recommended operating cross-flow rate: 600 to 800 ml/min per 0.11m² (1.2-ft²) Kvick Lab cassette. Run until no bubbles appear in the retentate stream.
6
Open the permeate valve. Adjust the retentate valve until the permeate flow is
about 10 percent of the feed flow. Adjust the feed pump to maintain a feed
pressure of 1.6 to 2.8 barg (25 to 40 psig) for ultrafiltration cassettes.
7
Circulate the buffer for four minutes to condition the system for pH and ionic
stability. If conditioning for temperature control, continue circulating until the
temperature of the system stabilizes.
8
Remove the buffer from the feed reservoir. Keep buffer in other parts of the system
to prevent air from entering the system.
3
1
2
4
7
6
5
8
Figure 3-6. Typical configuration for conditioning the system with buffer.
Kvick Lab Operating Instructions 28-9646-76 AA
41
3
3.7
Installation
Spare parts and accessories
Table 3-8. Parts in Figure 3-6.
Part
Description
Part
Description
1
Feed reservoir
2
Valve
3
Pressure gauge
4
Retentate
5
Kvick Lab cassette
6
Pump
7
Permeate
8
Feed
3.7 Spare parts and accessories
For correct up to date information on spare parts and accessories, visit:
www.gelifesciences.com/filtration
42
Kvick Lab Operating Instructions 28-9646-76 AA
Operation 4
Operation overview 4.1
4 Operation
4.1 Operation overview
The actual operation of the system will vary considerably depending upon your process
and product objectives. If you need assistance with application information, contact
your GE Healthcare representative.
Equipment configuration and process conditions for cross-flow processes vary widely
depending upon the application, system design, process objectives, and product
objectives. However, many cross-flow processes share three main stages:
•
Startup
•
Steady state operation
•
Shut down and product recovery
4.2 Starting the instrument
NOTICE
If you operate the pump dry (without any process fluid in it), you can
damage the pump. To prevent damage to the pump, ensure that fluid is
present in the reservoir and feed line whenever you run the pump.
Before operating the pump, you should read the pump manufacturer’s user manual
that was supplied with the Kvick Lab system.
4.3 The pump control system
To operate the pump, press the UP ARROW or DOWN ARROW until the desired pump
RPM is displayed on the control panel display. Then press the FWD button to start the
Kvick Lab Operating Instructions 28-9646-76 AA
43
4
4.3
Operation
The pump control system
pump. You can control other pump operations by using the buttons on the control
panel.
Figure 4-1. Pump control panel buttons and display.
Table 4-1. Description of Figure 4-1.
44
Key
Description
FWD
Starts the pump running in the forward direction, pumping feed
solution to the cassette holder. If the pump is running in reverse when
the FWD button is pressed, the pump will slow to a stop and then
speed up in the forward direction.
REV
Starts the pump running in the reverse direction. If the pump is
running forward when the REV button is pressed, the pump will slow
to a stop and then speed up in the reverse direction.
STOP
Slows the pump to a stop
UP
ARROW
If the pump is running, pressing this button will increase the speed of
the pump to that shown on the display. If the pump is stopped,
pressing this button increases and displays the RPM speed that the
pump will obtain when you start it.
DOWN
ARROW
If the pump is running, pressing this button will decrease the speed of
the pump to that shown on the display. If the pump is stopped,
pressing this button lowers and displays the speed that the pump will
obtain when you start it.
ENTER
Pressing this button at anytime will store the RPM shown on the
display as the default RPM, which will be displayed whenever the
system is powered up.
SHIFT
Used by authorized personnel for programming.
Kvick Lab Operating Instructions 28-9646-76 AA
Operation 4
The pump control system 4.3
Key
Description
PROG
This enables those personnel with proper authorization to enter the
programming menus and program the operation of the pump.
STATUS
light
The STATUS light on the control panel glows red when the pump is
powered up and not rotating. The STATUS light glows green when the
pump is running.
Process flow in a cross-flow
system
A typical system for many cross-flow applications includes two or three pressure
gauges (for precise process control and safety), feed tank, permeate collection vessel,
and a drain line (Figure 1-3).
Recommended operating
conditions
When using your Kvick Lab cassette, fully open the permeate valve and adjust your
pump speed and retentate valve to achieve the recommended cross-flow rate. The
recommended operating conditions for many applications are:
Table 4-2. Recommended operating conditions.
Characteristic
Parameter
Transmembrane pressure
0.5 to 2.4 barg (25 to 35 psig)
Cross-flow rate
600 to 800 ml/min per 0.11 m³ (1.2 ft³)
cassette
pH range, long-term (operating or
storage)
2 to 13
pH range, short-term (cleaning)
1 to 14
Maximum operating temperature
50 °C
Maximum inlet pressure
4 barg (60 psig)
If your feed is particularly viscous or particulated or has other unusual physical
characteristics, contact the technical support team at GE Healthcare for assistance.
Stage 1—Starting the cross flow
process
Follow these steps to start a typical cross-flow process:
Kvick Lab Operating Instructions 28-9646-76 AA
45
4
4.3
Operation
The pump control system
1
Drain residual water from the system and equilibrate the system with water or
buffer.
2
Close the permeate valve; open the feed and retentate valves; and close the drain
valve (if equipped).
3
Direct the permeate line to an appropriate container or drain; for example, a
permeate container, waste container, or process drain.
4
Fill the feed tank with product. Start the feed pump and slowly circulate the product
through the system for about three to four minutes. Recirculation helps purge
trapped air from the flow channels, maximizing membrane performance.
5
Open the permeate valve. Slowly increase the pump speed until the optimal crossflow rate is achieved. Using the retentate valve, adjust the retentate back-pressure
until the system reaches the optimum transmembrane pressure.
Tip:
If you do not know the relationship between your pump speed setting and the
feed flow rate, it may be difficult to consistently achieve the process conditions
you desire. Therefore, to ensure consistent performance and ease of use, prepare
a pump curve on your feed pump before processing so that you know the
relationship between pump speed and flow rate.
6
Monitor the product level in the feed tank to ensure the pump does not run dry. As
the level drops, you can add additional product to the feed tank.
7
If needed, transfer diafiltration solution into the feed tank at a controlled rate to
maintain a working volume in the feed tank. (The required number of diafiltration
volume exchanges varies greatly with respect to the particular characteristics of a
product.) Typically, in crossflow processes, six volume exchanges of buffer are
commonly processed through the feed tank.
8
Continue processing following the steps below in the section entitled, Stage 2—
Operating the system in a steady state.
Stage 2—Operating the system
in a steady state
During steady state operation, you monitor the process and record the process
information that you need for product development, process development, process
validation, or quality control. Key operational data includes these:
46
•
Transmembrane pressure
•
Feed pressure
•
Retentate pressure
•
Product temperature
•
Feed volume (initial and final)
Kvick Lab Operating Instructions 28-9646-76 AA
Operation 4
The pump control system 4.3
•
Diafiltrate volume
•
Permeate flow rate
•
Permeate volume
•
Retentate cross-flow rate
•
Various product quality analyses
Stage 3—Shutting the system
down and recovering product
Before shutting your cross-flow filtration system down, you can complete two recovery
methods to maximize the recovery of product. One recovery method helps remove the
buildup of product on the surface of the membrane inside the cassette. The other
method helps you recover the most product volume from the system piping and
cassette.
Capturing product from the membrane surface
The first product recovery method involves reducing the cross-flow rate at the end of
your processing step. For example, when you finish processing your product, reduce the
cross-flow rate to 1/10 of the recommended processing cross-flow rate. Close the
permeate valve or reduce the feed pressure to 0.3 barg (5 psig). Retentate pressure
should be 0 barg (0 psig). Circulate the remaining product for 15 minutes. This procedure
will help recover product buildup from the surface of the membrane.
Maximizing the volume of product recovered
The second product recovery method maximizes the volume of product you can
recover from the system piping and cassette. The method involves slightly over
concentrating the product, then returning a small volume of permeate back into the
system to flush concentrated product from the feed-retentate loop. This method is
described below in the following steps:
1
As the process nears completion, decrease the pump speed to minimize flow rate,
vortexing in the feed tank, and the possibility for product foaming.
2
When you reach the slightly over concentrated volume, collect about 100 to 500 ml
of permeate depending upon the installed membrane area and nature of the
product) in a container. (Typical volumes of permeate are about 100 to 500 ml for
lab/pilot systems or considerable more for pilot/production systems.) Stop the
pump and close the permeate valve.
3
Attach a line to the drain valve and connect the other end aseptically to your
collection vessel (Figure 4-2).
Tip:
If maximum recovery is required, you can remove product from the system by
applying a low-pressure nitrogen flow to the retentate side of the system. Contact
your GE Healthcare’ representative for additional details.
Kvick Lab Operating Instructions 28-9646-76 AA
47
4
4.3
Operation
The pump control system
NOTICE
Many types of pumps will be damaged if you run them dry. Therefore,
monitor the liquid level in the tank and shut off the pump when the tank
is empty.
4
Open the drain valve, and with the retentate valve open, start-up the pump at a
slow speed. Apply back-pressure by slightly closing the retentate valve if needed to
assist in removal of product from the drain line. Stop the pump as the tank fully
drains.
5
Close the drain valve. Add a portion of saved permeate to the feed tank and
circulate for two to three minutes. Open the drain valve and circulate (and apply
back-pressure by slightly closing the retentate valve if needed) to drain the product
from the feed-retentate loop. Stop the pump. Repeat step 5 as needed to recover
the maximum volume of product.
2
1
9
3
8
10
4
5
6
12
11
7
13
Figure 4-2. Typical flow path for shutting down and recovering product.
Table 4-3. Description of flow path in Figure 4-2.
1
48
Retentate
Kvick Lab Operating Instructions 28-9646-76 AA
Operation 4
The pump control system 4.3
2
After recovering a product from the drain line, add a portion of the
collected permeate, circulate, and drain into your product collection
vessel.
3
Feed reservoir
4
Feed
5
Pump
6
Drain line
7
Collection
8
Valve
9
Pressure gauge
10
Kvick Lab holder
11
Collection
12
Permeate
13
As you near the end of processing collect 200 to 500 ml of permeate
for flushing the system.
Kvick Lab Operating Instructions 28-9646-76 AA
49
4
4.3
50
Operation
The pump control system
Kvick Lab Operating Instructions 28-9646-76 AA
Maintenance 5
General 5.1
5 Maintenance
5.1 General
The system should be flushed after each use and before storage. Normally, when you
flush the cassette and holder after use, you simultaneously flush and clean the Kvick
Lab system, and no further flushing is needed.
5.2 User maintenance schedule
Inspection
Periodically—based on usage—you should make these inspections:
•
Inspect and perform maintenance on the Kvick Lab cassette holder as described
on 54.
•
Inspect and perform maintenance on the rotary lobe pump as described in the
rotary lobe pump user manual.
•
Inspect piping connections for tightness and worn gaskets after each run.
5.3 Cleaning
If the last operation you perform with the system is to flush the cassette with a storage
solution, you must then flush the system and holder with deionized (DI) water or waterfor-injection (WFI) to remove the storage solution. Use an old cassette in the holder to
flush the system with water. You can also cut the center out of two gaskets and install
the gaskets in the holder for flushing (Figure 5-1).
After use, you should wipe down the exterior components of the Kvick Lab system with
DI water or WFI to remove dirt and residual process/cleaning solutions. Wipe the holder
dry with a clean, lint-free cloth.
Figure 5-1. Gasket with center cut out for flushing a holder with water.
Kvick Lab Operating Instructions 28-9646-76 AA
51
5
5.4
Maintenance
Cleaning and storing cassettes
Storing the system
To store the system for more than a few days, clean it as described in the maintenance
section. Drain all rinse water from the system. Remove the cassettes from Kvick Lab
holder. Blank off open lines or ports in the system and reservoir. Store the cassette in
accordance with the instructions in the cassette user manual.
5.4 Cleaning and storing cassettes
Introduction
You can reuse cassettes if you clean and store them properly. The cleaning and storage
stages include these:
Cleaning the Cassette
Rinsing the cassettes with water prior to cleaning ensures the most effective use of the
cleaning solution and prevents solubility changes that can prevent effective cleaning.
Flushing with the cleaning solution dissolves and physically removes contaminates
from the cassette. Flushing with water removes the cleaning solution from the cassette.
Measure the Water Flux
You measure the water flux and compare it to the water flux when the cassette was
new. You can then determine cleaning effectiveness.
Store the Cassette and Holder
Storing the cassette and holder involves adding a storage solution and preparing the
system for short-term or long-term storage. The goal is to keep the membrane wet and
to prevent microbial growth during storage.
Stage 1—Cleaning a cassette
after use
You can reuse a cassette if you clean and store it properly. To clean a used cassette,
flush it with buffer, WFI, or DI water as described in Stage 1—Rinse storage solution from
the cassette on page 31. Then clean the cassette following these steps:
52
1
Configure the system so that the retentate and permeate lines discharge to waste
(Figure 3-1). Close the feed, retentate, and permeate valves.
2
Prepare the appropriate volume of a cleaning solution (1.5 to 2 liters per 0.11 m²
(1.2 ft ²) Kvick Lab cassette. Table 5-1 describes recommended cleaning solutions.
3
Fill the feed reservoir with the cleaning solution.
Kvick Lab Operating Instructions 28-9646-76 AA
Maintenance 5
Cleaning and storing cassettes 5.4
4
Open the feed and retentate valves and pump about 10 percent of the cleaning
solution through the retentate line to waste. Open the permeate valve and close
the retentate valve and pump about 10 percent of the cleaning solution through
permeate line to waste.
5
Stop the pump and configure the system so that the retentate and permeate lines
discharge into the feed reservoir. Fully open the feed and retentate valves. Crack
open the permeate valve.
6
Start the pump. Adjust the retentate valve and pump speed to obtain 1 to 1.5 times
your processing cross-flow rate.
7
Circulate the cleaning solution for 30 to 60 minutes.
8
Drain the cleaning solution from the system using the drain line.
9
Rinse the cassette and system with clean water as described in Stage 1—Rinse
storage solution from the cassette on page 31.
Table 5-1. Cleaning agents and conditions.
Cleaning agent
Cleaning conditions
0.5 M NaOH
30 minutes at room temperature
1 M NaOH
2 hours at 50°C
0.5 M NaOH with 300 ppm NaOCl
30 minutes at room temperature
0.5 M NaOH then 0.5 M H2SO4
30 minutes at room temperature for
each solution
Double cleaning with 0.5 M NaOH with
300 ppm NaOCl
30 minutes at room temperature for
each cycle
Stage 2—Measuring water flux
To determine the effectiveness of cleaning and the end of the service life of the cassette,
you should measure the water flux after cleaning. Compare the most recent water flux
measurement with previous flux measurements.
To determine the cassette’s water flux, follow the procedure described in this user
guide. However, instead of measuring the flux at the two recommended pressures,
measure the flux flow at the target pressure for your type of cassette—0.7 barg (10 psig)
for ultrafiltration cassettes—and determine the cassette’s water flux normalized to a
water temperature of 20°C.
Interpreting water flux values
Compare the post-cleaning flux value with the as new flux values. If the post-cleaning
flux values are less than 60 to 80 percent of the new flux values, you may have to repeat
or change the cleaning procedure. If, after all cleaning attempts, the post-cleaning flux
Kvick Lab Operating Instructions 28-9646-76 AA
53
5
5.5
Maintenance
Maintenance of the holder
values are still less than 60 to 80 percent of the new flux values, you may want to
replace the cassette.
Stage 3—Storing the cassette
and system
Short-term storage
After completing stages 1 and 2, flush the cassette with a storage agent as described
below to keep the membrane wet and minimize biological growth:
•
For storage less than 3 days, use 0.2 µm filtered water
•
For storage less than 6 months, use 0.1N NaOH
•
For storage longer than 6 months, use a storage solution of 0.1N NaOH and store
the cassette at 4°C.
For long-term storage (more than ten days), remove the cassette from the holder and
place it into an air-tight plastic tub or heavy duty, zip-lock-type plastic bag. Add about
50 to 100 ml of the storage agent to the plastic bag and seal it. Place the sealed bag in
a protected location at a temperature of 4°C.
For short-term storage (five to ten days), keep the cassette in the holder and circulate
the storage solution for 10 to 15 minutes, close the system valves, disconnect the
electrical power to the feed pump, and ensure the feed reservoir is properly sealed. On
manually-clamped holders, loosen the tie rod nuts alternately turn at a time until you
can just turn the nuts by hand. Tighten the nuts to a torque of 10 to 15 Nm (88 to 133
in-lbs). On hydraulic systems, keep the cassettes and gasket in the holder and
pressurize the hydraulic system to 35 to 69 barg (500 to 1000 psig) to prevent fluid from
leaking from the cassette holder.
5.5 Maintenance of the holder
WARNING
Inspecting the cassette holder without shutting down the cross-flow
system to which it is attached (disconnecting the power cable,
disconnecting the compressed air supply, and decompressing the
system) can result in bodily injury from the accidental starting of the
pump or unexpected release of pressure.To prevent bodily injury,
disconnect the power cable, disconnect the compressed air line, and
depressurize the system before performing inspections and
maintenance on the system.
54
Kvick Lab Operating Instructions 28-9646-76 AA
Maintenance 5
Replacement of fuses 5.6
Inspection
Periodically—based on usage—you should make these inspections:
•
Inspect the tie rods and nuts for excessive wear and replace as needed.
•
Inspect the mating surfaces of the flow manifold and backing plate for scratches.
•
Inspect the sanitary connection gaskets for damage or wear and replace the
gaskets as needed.
•
Check the rigidity of the stand. If the stand wobbles, tighten the screws that hold
the legs and cross braces together.
If the mating surfaces of the flow manifold and backing plate become excessively
scratched, contact your GE Healthcare representative for assistance.
Maintenance
After using the holder, you should wash down the exterior components with clean water
to remove dirt and residual process/cleaning solutions. Blow the wash water out of the
flow manifold channels with compressed air. Wipe the holder dry with a clean, lint free
cloth.
Tip:
The nut torque values are based on the tie rod threads being dry. You should not
oil the tie rod threads. Oiled tie rod threads will result in too much clamping
pressure being applied to the cassette.
Storing the holder
To store the holder, clean it as noted above and place several layers of a clean cloth
between the flow manifold and the backing plate. Install the spacers, washers, and
nuts, and lightly hand tighten to hold the cloth and backing plate in place. Place the
holder in a dry, protected area such as a cabinet to prevent contamination or accidental
dropping.
5.6 Replacement of fuses
The 115- and 230-volt versions of the pump use one fuse located in the power switch
to protect the pump from damage. Follow these steps to replace the fuse:
1
Disconnect the pump and cross flow system from power sources. Unplug the
power cord from the pump’s electrical supply outlet and the power switch module
on the back of the pump housing.
2
Insert a small screwdriver into the slot on the top of the power switch module and
gently pry the power switch module cover outward from cabinet.
3
Insert a small screwdriver into the slot at the top of the red fuse holder and gently
pry the fuse holder from the power switch module. As you pull the fuse holder from
Kvick Lab Operating Instructions 28-9646-76 AA
55
5
5.6
Maintenance
Replacement of fuses
the power switch module, one fuse and one dummy fuse will pop out from the sides
of the fuse holder.
4
Replace the old fuse with a new fuse—250 volt, 10 amp, fast blow, ABC10A type,
31.75 mm × 6.35 mm (1.2 in × 0.25 in).
5
Orient the fuse holder so that the proper voltage designation faces up. Place and
hold the new fuse and the dummy fuse in the fuse holder. Insert and press the fuse
holder into the power switch module until it clicks into place.
6
Reposition the power switch cover over the fuse holder and press the cover against
the fuse holder until it clicks into place. Ensure the correct voltage designation (115
VAC or 230 VAC) shows through the window in the power switch module. The
voltage that shows in the window should match the voltage on the pump label on
the back of the pump cabinet.
WARNING
Make sure that the voltage displayed on the power module is the same
as the voltage available from the power outlet. The wrong voltage
setting may lead to electrical and fire hazards.
System disposal
When the service life of the unit is reached, flush the system to remove hazardous
process fluids. Dispose of the unit in accordance with the government and
environmental regulations that pertain to your location.
Replacing the power cord
If the power cord becomes worn or damaged, always replace it with an identical power
cord.
56
Kvick Lab Operating Instructions 28-9646-76 AA
Troubleshooting 6
6 Troubleshooting
Consult Table 6-1 if the Kvick Lab system does not work properly.
Table 6-1. Troubleshooting chart.
Symptom
Possible cause
Suggested remedy
Leaks at the tubing nipple at
permeate connection of
cartridge.
Inside dimension of tubing is
too large.
Ensure tubing i.d. is sized
properly for the connection.
Split tubing at barb Check
tubing for wear or splitting.
Replace tubing if necessary.
Tubing clamp incorrectly
installed.
Ensure the clamp is installed
and tight.
Process solution leaks from
sanitary connections.
Clamp is loose.
Check and tighten clamp.
Gasket worn, damaged,
improperly mounted or wrong
size.
Inspect gasket for wear,
damage and proper sizing.
Replace if necessary.
Feed pressure increases from
starting values slowly at first,
then suddenly very rapidly,
exceeding process limit.
Blockage or partial blockage of
flow path.
Flush through to clean
blockage. If necessary replace
tubing and connectors. Please
refer to order information for
tubing and connectors.
Feed inlet at cartridge is
blocked.
Switch feed and retentate lines
to reverse flow and flush with
deionized water (DI) or water
for injection (WFI).
Fouled cartridge.
For feed flow rate versus
pressure drop and cleaning of
cartridge refer to Operating
Handbook - Hollow fiber
cartridges for membrane
separations.
Retentate valve closed or
restricted.
Open valve.
Speed of pump (RPM) is too
high.
Reduce pump speed.
No or low retentate pressure.
Kvick Lab Operating Instructions 28-9646-76 AA
57
6
Troubleshooting
Symptom
Possible cause
Suggested remedy
Feed pressure is too low.
Pump head is not turning.
Check for error messages on
pump display, check voltage
setting is correct on power
supply and power is delivered
to the motor.
Air leaking from cartridge or
housing during cartridge
integrity testing (Cartridge
integrity testing employs air on
the retentate side of a fully
wetted cartridge).
Cartridge not wetted properly.
Cartridge not been wetted
properly. Please read the
chapter New cartridge rinsing
procedure in the Operating
Handbook - Hollow fiber
cartridges for membrane
separations. For pre-treatment
with alcohol please read the
document Hollow fiber
cartridge preparation
instructions.
Membrane is not integral.
Please contact your local GE
Healthcare technical support
representative.
Faulty diaphragm valve.
Get valve serviced by GE
Healthcare service engineer or
replaced.
Gasket worn, damaged,
improperly mounted or wrong
size.
Inspect gasket for wear,
damage and proper sizing.
Replace if necessary.
Leakage from process
connectors.
Check and tighten connectors.
Water leaking during system
integrity testing (System
integrity testing employs water
on the retentate side).
58
Kvick Lab Operating Instructions 28-9646-76 AA
Troubleshooting 6
Symptom
Possible cause
Suggested remedy
Permeate flow is not adequate
(microfiltration membrane).
Air trapped in the pore
structure of the membrane.
Air-locked membrane, in which
case, water layers trap a
pocket of air between inner
and outer surfaces of the
membrane; effectively
reducing the available surface
area. This may be observed
following autoclaving. Remedy:
recirculate cold water (5-15C)
on the retentate side with the
permeate side closed, very
gradually increase retentate
back-pressure until a stable 20
psig is reached and hold this
condition for 10 minutes or
until expected permeate flux is
reached Note that this does not
affect feed pressure or TMP;
due to the permeate side being
closed, but only raises the
absolute pressure on both
sides of the membrane;
causing the trapped air to
diffuse rapidly into the water.
Kvick Lab Operating Instructions 28-9646-76 AA
59
6
Troubleshooting
Symptom
Possible cause
Suggested remedy
Permeate flow is not adequate
(ultrafiltration membrane).
Air trapped in the pore
structure of the membrane, or
glycerol humectant not
properly removed.
Cartridge not wetted properly.
Please read the chapter New
cartridge rinsing procedure in
the Operating Handbook Hollow fiber cartridges for
membrane separations. For
pre-treatment with alcohol
please read the document
Hollow fiber cartridge
preparation instructions.
Auxiliary equipment such as
manometers and pumps not
working properly.
Check the function of all
auxiliary equipment. Repair/
replace if necessary.
Bent tubing.
Check that the flow path is not
restricted.
Liquid viscosity too high.
Check the viscosity of the
liquid. Viscosity is a function of
temperature. (Lower
temperature gives higher
viscosity.) Let low-temperature
liquid reach operating
temperature before starting
the run.
Microbial growth in buffers. The
buffer normally becomes
opalescent due to microbial
growth.
Check buffers, especially those
with phosphate, for microbial
growth. Replace with fresh
buffer if necessary.
Dimension of tubing is
incorrect.
Ensure tubing i.d. is sized
properly for the connection.
Fouled cartridge.
Clean the cartridge according
to instructions.
Split tubing at barb Check
tubing for wear or splitting.
Replace tubing if necessary.
Tubing clamp incorrectly
installed.
Ensure the clamp is installed
and tight.
Permeate pressure is dropping.
60
Kvick Lab Operating Instructions 28-9646-76 AA
Troubleshooting 6
Symptom
Possible cause
Suggested remedy
Unexpected passage of target
protein to the permeate side.
Membrane pore size is too
large for target molecule.
Select the largest pore size that
retains the target molecule (in
general choose a membrane 35× smaller than the target
protein). For example, either
30,000 or 50,000 NMWC
ultrafiltration membranes are
recommended for mAb
concentration and diafiltration.
Unexpected retention of target
molecule.
Membrane pore size is too
small for target molecule.
Select the smallest pore size
that still allows efficient
passage of the target molecule
(in general 10 x larger opening
than the target protein) For
most mammalian cell culture
clarification 0.2 to 0.65 micron
pore sizes are used.
Kvick Lab Operating Instructions 28-9646-76 AA
61
6
62
Troubleshooting
Kvick Lab Operating Instructions 28-9646-76 AA
Reference information 7
Kvik Lab system specifications 7.1
7 Reference information
7.1 Kvik Lab system specifications
Size and dimensions
Parameter
Specification
Dimensions,
approximate
(W×L×H) 38×61×53 cm (15×24×21 inches)
Weight, approximate
68 kg (150 lbs)
Materials of construction
Parameter
Specification
Wetted parts,
excluding cassette
316L stainless steel, EPDM gaskets and diaphragms
Operating parameters
Parameter
Specification
Recommended operating temperature
5 to 50°C
Maximum temperature, steaming/
autoclaving (no cassettes)
121°C (250°F), not including pump or
pressure gauges in autoclave.
Maximum temperature, operating (pump
rotor limited)
60°C (140°F)
Recommended maximum inlet pressure
3 barg (45 psig)
Operating pH
1 to 14
Reservoir volume
2500 ml
2
175 ml
Minimum working volume with five 0.11 m
2
(1.2 ft ) cassettes
2
250 ml
System holdup volume
20 ml
Minimum working volume with one 0.11 m
2
(1.2 ft ) cassette
Kvick Lab Operating Instructions 28-9646-76 AA
63
7
7.1
Reference information
Kvik Lab system specifications
Pump
Parameter
Specification
Inlet and outlet ports (250 pump)
3/4-inch sanitary fittings
Rotors, material of construction
Stainless steel
Maximum temperature, operating (pump
rotor limited)
50°C (122°F), steamable rotors, not
autoclavable
Maximum temperature, steaming/
autoclaving (pump stopped)
121°C (250°F)
Input voltage, 250 pump, 115 VAC version
104-126 VAC, 60/50 Hz
Max. input current
8.9 A
Input voltage, 250 pump, 230 VAC version
200-230 VAC, 50/60 Hz
Max. input current
3.8 A
Pump fuse rating
250 volt, 10 amp, fast-blow, ABC10A
type, 31.75 mm × 6.35 mm (1.2 in ×
0.25 in)
Flow rate
0 to 12 liters (0 to 3 gallons) at 1.4
barg (20 psig) of back pressure
High pressure cut-off system
Stops pump at feed pressure of 4
barg (60 psig)
See the pump manufacturer’s user manual for additional details.
64
Kvick Lab Operating Instructions 28-9646-76 AA
Reference information 7
Kvik Lab system specifications 7.1
Kvick Lab cassette holder
Fittings
Parameter
Specification
Feed, retentate, and permeate port fittings
1/2 inch sanitary
Wetted parts
Parameter
Specification
Flow distribution manifold
Polished 316L stainless steel, Ra <0.8 µm
Back plate
Polished 316L stainless steel
Non-wetted parts
Parameter
Specification
Tie rods, washers, stand
Stainless steel
Tie rod nuts
Bronze
Operating parameters
Parameter
Specification
Recommended operating flow rate
7 to 8 l/min/m of installed membrane
2
area (650 to 750 ml/min/ft of installed
membrane area) with a retentate
pressure of 0.7 barg (10 psig)
Recommended operating
temperature
5°C to 50°C
Maximum operating temperature
121°C (250°F)
Recommended operating pressure
0.34 to 3 barg (5 to 45 psig)
Operating pH
1 to 14
Hardware holdup volume (feed/
retentate)
less than 2 ml
Maximum membrane area
0.55 m (6.0 ft )
2
2
2
Type and number of cassettes:
Parameter
Specification
Kvick Lab
0.11 m (1.2 ft ), maximum of 5 cassettes installed
Kvick Lab Operating Instructions 28-9646-76 AA
2
2
65
7
7.2
Reference information
Chemical compatibility
Parameter
Specification
Cassette holdup volume
20 ml
7.2 Chemical compatibility
You can damage a Kvick Lab cassette holder by exposing it to chemicals incompatible
with stainless steel. The gaskets used to connect piping to the sanitary fittings of the
holder are made of EPDM, and are resistant to many types of chemicals (Table 7-1).
Consult the GE Healthcare Cassettes: Instructions for Use manual for guidelines on the
chemical compatibility of cassettes.
Table 7-1. Chemical resistance of Kvick Lab and cassette holder wetted parts.
Chemical
SS 316L resistance
EPDM resistance
Acetic acid 1.7 M
Resistant
Resistant
EtOH 20%
Resistant
Resistant
EtOH 40%
Resistant
Resistant
Ethylene glycol
Resistant
Resistant
Formaldihyde
Resistant
Resistant
Formic acid 10%
Resistant
Resistant
Glycerol 100%
Resistant
Resistant
Hydrochloric acid 0.1 M
Not recommended
Resistant
Isopropyl alcohol 30%
Resistant
Resistant
Nitric acid 0.1 M
Resistant
Resistant
Phosphoric acid 25%
Limited Resistance
Resistant
2
Resistant
3
Sodium Chloride 0.5 M
Resistant
Sodium hydroxide 2 M
Resistant
Resistant
Trifluoroacetic acid 0.1%
Resistant
Resistant
Resistant
Resistant
Resistant
Resistant
Triton
TM
X-100 100%
Urea 8 M
66
2
Sodium chloride can cause corrosion on stainless steel at pH less than 5. Do not use
sodium chloride in storage solutions.
3
Maximum recommended exposure is 4 hours.
Kvick Lab Operating Instructions 28-9646-76 AA
Reference information 7
Service and training 7.3
7.3 Service and training
Contact GE Healthcare or visit www.gelifesciences.com for information on service and
training.
7.4 Ordering information
For spare parts and other ordering information visit www.gelifesciences.com.
Kvick Lab Operating Instructions 28-9646-76 AA
67
7
7.4
68
Reference information
Ordering information
Kvick Lab Operating Instructions 28-9646-76 AA
Appendix A
Drawings A.1
Appendix A
A.1 Drawings
A.1.1
Perspective
2
1
3
4
5
6
7
8
9
Figure A-1. Exploded view of Kvick Lab.
Kvick Lab Operating Instructions 28-9646-76 AA
69
Appendix A
A.1
Drawings
Table A-1. Parts in Figure A-1.
70
Part
Description
1
Manual feed port and sight glass 2-inch TC (optional)
2
Vent or diafiltration port
3
Permeate line, 3/8-inch stainless steel hose barb
4
Cooling water outlet (Use is optional) use supplied propylene, 1/2-inch
male NPT to 3/8-inch hose barb fittings to connect heating and
cooling water inlet and outlet.
5
Pressure gauge, 3/4-inch TC on both ends
6
Compressed air inlet, 3/8-inch stainless steel hose barb
7
Drain line side of diverter valve
8
Reservoir outlet and retentate inlet, 3/4-inch TC
9
Pump inlet and outlet, 3/4-inch TC
Kvick Lab Operating Instructions 28-9646-76 AA
Appendix A
Drawings A.1
A.1.2
Front view
1
2
3
4
Figure A-2. Exploded front view of Kvick Lab. (some versions of this system include fully jacketed
tanks)
Table A-2. Part in Figure A-2.
Part
Description
1
Heating/cooling water outlet
2
Heating cooling water inlet
3
Feed line
4
Compressed air inlet
Kvick Lab Operating Instructions 28-9646-76 AA
71
Appendix A
A.2
Using the cartridge adaptor kit
Note: All undesignated sanitary connections are 1/2-inch.
A.2 Using the cartridge adaptor kit
Installing the hollow fiber
cartridge adapter kit on a Kvick
Lab system
This instruction describes how to install the GE Healthcare cartridge adaptor kit that
enables you to use Xampler™, size 3, 4, 5 and 6 hollow fiber cartridges with your Kvick
Lab system.
Your adapter kit contains the following parts:
72
•
8-inch x 8-inch base plate with 2-piece support rod
•
Cartridge mounting bracket (top) with manifold
•
Cartridge mounting bracket (bottom) with mounting blocks
•
Two, 0 to 4 barg (0 to 60 psig) pressure gauges
•
Two pressure gauge mounting adapters with TC ends
•
Drain valve
•
Three elbows with TC ends
•
Short-outlet tee with TC ends
•
Feed manifold with TC ends
•
Two, 1 1/2-inch TC clamps
•
Twelve, 1/2-inch gaskets
•
Twelve, 1/2-inch clamps
•
Three, 3/8-inch hose barb fittings with TC ends
•
Three, 3-foot sections of 3/8-inch ID tubing
•
Three hose clamps
•
Two, 1 1/2-inch TC to 1/2-inch TC adaptors, polysulfone
•
Two, 1 1/2-inch TC gaskets, silicone
•
Two, 1 1/2-inch TC quick disconnect clamps, nylon
Kvick Lab Operating Instructions 28-9646-76 AA
Appendix A
Using the cartridge adaptor kit A.2
Preparing to install the adapter
kit
1
Gather an adjustable wrench and a 7/16-inch box wrench.
2
Unpack the adapter kit and lay out components on the laboratory bench next to
your Kvick Lab system.
3
Depressurize your Kvick Lab system and disconnect any lines from the drain side
of the diverter valve.
4
Learn where to install the adapter kit components by reviewing the flow chart
(Figure A-3).
Assembling the stand
1
Screw the lower half of the support rod into the stand and tighten just snug using
the adjustable wrench and the support rod bosses.
2
Screw the top half of the support rod into the bottom half of the support rod and
tighten just snug with the adjustable wrench.
3
Install the lower cartridge mounting bracket on the support rod using the mounting
blocks and the 7/16-inch wrench (Figure A-4).
4
Install the upper cartridge mounting bracket by slipping it over the support rod and
tightening the hand lock. Install the pressure gauge and piping (Figure A-5).
1
3
2
5
4
6
10
7
11
8
9
12
16
13
17
14
15
18
19
20
Figure A-3. Process flow diagram of a Kvick Lab system with the cartridge adapter kit and hollow
fiber cartridge installed.
Kvick Lab Operating Instructions 28-9646-76 AA
73
Appendix A
A.2
Using the cartridge adaptor kit
Part
Description
Part
Description
1
Kvick Lab cassette holder
11
Reservoir
2
Pressure gauge
12
Cooling and heating jacket
3
Feed
13
Capped permeate port
4
Retentate line tubing
14
Compressed air for integrity
testing
5
Permeate collection
15
Pump
6
Valve
16
Retentate inlet
7
Hollow fiber cartridge
17
Cooling/heating water outlet
8
Permeate collection
18
Feed
9
Cooling /heating water inlet
19
Diverter valve
10
Vent or diafiltration inlet
20
Drain and recovery
Assembling the piping
Without fully-tightening the sanitary clamps, assemble the feed-line components
(piping, elbows, adapters, pressure gauge, valve, gaskets, and clamps). Use Fig 1-1, Fig
1-2, and Fig 1-3 as guides. Once assembled, connect the feed-line assembly to the feed
piping on the lower mounting bracket and the system’s diverter valve. Tighten the
sanitary clamps.
Cut and attach tubing to the retentate hose barb using a tubing clamp. Attach a hose
barb adaptor and clamp to the other end of the tubing. Attach the tubing to the feed
reservoir port using a TC gasket and clamp.
Note: Adapters for Size 5 and 6 Cartridges—To install a size 5 or 6 cartridge, attach the
two 1 1/2-inch TC to 1/2-inch TC adapters to the cartridge using the 1 1/2-inch
gaskets and clamps. Then follow the procedure in Step 4, Install a hollow fiber
cartridge.
Note: Minimizing the working volume—To minimize the working volume of the system,
cut a 3 1/2-inch piece of tubing and attach it to the bottom of the reservoir dip
tube.
74
Kvick Lab Operating Instructions 28-9646-76 AA
Appendix A
Using the cartridge adaptor kit A.2
1
2
3
6
4
7
5
8
Figure A-4. Lower (left) and upper (right) cartridge mounting brackets.
Part
Description
Part
Description
1
Feed manifold
5
Feed elbow
2
Mounting bracket
6
Hose barb adapter on tubing
clamp
3
Rubber mounting block
7
Pressure gauge adapter
4
Support rod
8
Upper cartridge mounting
bracket and Retentate
manifold
Figure A-5. Feed line assembly with blue arrow pointing at diverter valve. with the adapter
installed, one outlet feeds the cassette holder and one outlet feeds the cartridge.
Kvick Lab Operating Instructions 28-9646-76 AA
75
Appendix A
A.2
Using the cartridge adaptor kit
Install a hollow fiber cartridge
Cartridge with sanitary connectors
1
Gather the cartridge and its two gaskets, and two sanitary clamps of the
appropriate size.
2
Raise upper cartridge-mounting bracket so that distance between upper and lower
manifolds exceeds cartridge length.
3
Place a gasket on the sanitary flange of the feed piping. Place the end of the
cartridge on the gasket and sanitary flange and secure with a sanitary clamp
(Figure A-3).
4
Place a gasket on upper end of the cartridge.
5
Loosen the upper cartridge mounting bracket and slide it down to mate with
gasket and upper end of cartridge.
6
Tighten upper manifold hand knob to secure it in place.
7
Secure the end of the cartridge to the upper manifold with a sanitary clamp.
Cartridge with tubing nipples (QAK-2 kit required)
1
Gather the Xampler size 4 cartridge, two 1/2-inch silicone gaskets and fractional
sanitary clamps, two cartridge-to- manifold adapters, two long tube standoffs, two
hose barb O-rings, and two short tube standoffs.
2
Raise upper manifold so that distance between upper and lower manifolds
exceeds cartridge length.
3
Clamp the tubing nipple adapters to the upper and lower manifolds using the
silicone gaskets and sanitary clamps.
4
Push a long tube standoff onto each cartridge tubing nipple.
5
Push an O-ring onto each cartridge tubing nipple and seat it against the standoff.
6
Push a short tube standoff onto each cartridge tubing nipple and seat it against the
O-ring.
7
Wet the O-rings with water, and with the standoffs and O-rings in place, use a
twisting motion and firmly slide the lower end of the cartridge into the lower
manifold adapter.
8
Slide the upper manifold assembly down to mate with the upper end of the
cartridge and press firmly.
9
Tighten upper manifold hand knob to secure it in place.
Which cartridges can you install?
The Kvick Lab cartridge adapter kit can hold the following types of cartridges depending
upon the cassette type and the membrane area your application requires:
76
Kvick Lab Operating Instructions 28-9646-76 AA
Appendix A
Using the cartridge adaptor kit A.2
•
Xampler size 3M and 3×2M
•
Xampler size 4, 4M, and 4×2M
•
Pilot size 5 and 6
Operating parameters
Parameter
Value
Recommended operating temperature
5°C to 50°C (41°F to 122°F)
Maximum steaming/autoclaving
temperature (no cartridge)
121°C (250°F)
Maximum operating temperature
(pump rotor limited)
60°C (140°F)
Recommended maximum inlet pressure
3 barg (45 psig)
Operating pH
1 to 14
Reservoir volume
2500 ml
System holdup volume
20 ml
System working volume with size 3M
cartridge
200 ml
System working volume with size 6
cartridge
500 ml
Kvick Lab Operating Instructions 28-9646-76 AA
77
Appendix A
A.2
78
Using the cartridge adaptor kit
Kvick Lab Operating Instructions 28-9646-76 AA
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www.gelifesciences.com/filtration
Kvick Lab and Kvick are trademarks of GE Healthcare companies.
© 2010 General Electric Company—All rights reserved.
First published Feb. 2010.
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terms and conditions is available on request. Contact your local GE
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imagination at work
28-9646-76 AA 02/2010