Appendix 1
PTC/MEA/VS
Jan 2008
MP/MEX/07/005
Phase-out of CFC consumption in the Manufacture of
Aerosol Metered Dose Inhalers (MDIs) in the United
Mexican States (MEXICO)
TERMS OF REFERENCE FOR THE PROVISION OF
MANUCATURING EQUIPMENT FOR METERED
DOSE INHALERS (MDIs) IN
HYDROFLUOROALKANE (HFA) PROPELLANT
AT LABORATORIOS SALUS, S.A. de C.V., MEXICO
UNIDO
2008
Appendix 1
1
Scope of the project
The project shall cover the design, manufacture, testing, shipping, installation and
commissioning of a suite of manufacturing equipment which may be integrated with
existing equipment at Laboratorios Salus.
2
Project Background
Substances (ODS), in the form of Chlorofluorocarbon propellants, in the production of
Metered Dose Inhalers (MDIs) in Mexico. The Metered Dose Inhalers (MDIs) containing
Ozone Depleting Substances (ODS), shall be replaced by equivalent MDIs containing
propellants with negligible ozone depleting effect e.g. Hydrofluoroalkanes. In order to
achieve the primary objective it is required to manage the transition from CFC based
MDIs to CFC Free MDIs in the country. This involves conversion of Laboratorios Salus,
S.A. de C.V. the only eligible manufacturer of aerosol MDIs in Mexico.
Following review of the various technology approaches and based on the experience from
other countries, it was felt critical that the MDI format is maintained. It is a form of delivery that
the patients are familiar with and therefore transition at a patient level shall be far easier to
manage. In addition the MDI offers the most cost effective method for inhalation delivery,
therefore minimizing the potential incremental operating costs that shall be realized in the
transition from CFC MDIs. In addition both enterprises have confirmed they wish to stay with
the MDI as the drug delivery system.
The objectives of this project is to phase-out the use of CFC-11 and CFC-12 in the
manufacture of Salbutamol, Beclomethasone Dipropionate and Sodium Cromoglicate
Aerosol Metered Dose Inhalers (MDIs) at Laboratorios Salus, S.A. de C.V. in which
represent about 70% of the consumption in the Social Security (IMSS, ISSSTE) in
Mexico. In addition the successful completion of implementation of the project will result
in the substitution of the Atrovent and Berodual MDIs currently produced in Mexico by
Boehringer Ingelheim, SA de CV, with Boehringers CFC free MDI product, this will
account for an additional elimination of 26 tones of CFC-11, CFC114 and CFC12.
To implement the selected replacement technologies, Laboratorios Salus, S.A. de C.V.
will require technology transfer from one or more, established multinational enterprises
that have experience in the development and manufacture of MDIs using CFC free
technologies, and who have the right to transfer such technology without infringement of
any intellectual property related to either the drug molecule, the method of formulation,
the design of the metering valve or actuator, or the filling process. This proposal
addresses the conversion to a manufacturing facility of MDI using HFCs.
The transition process from CFC MDIs to HFC MDIs in Laboratorios Salus, S.A. de C.V.
requires that for a period of some time, there will be a need of production of both CFCMDIs and HFC-MDIs and therefore the plan should allow for support of market and
patient needs through the transition period.
Laboratorios Salus, S.A. de C.V. is the main CFC-based MDl producer in Mexico. The
company, with 100% national ownership, was founded in 1946 and it has been
producing CFC-based MDls since 1995. 70% of Salus' production covers the supply to
the Mexican Health System. The remaining 30 % goes to the free market of the country.
2
Appendix 1
Laboratorios Salus, S.A. de C.V. is 100% Mexican owned and is part of the "IFACO
Group". The "IFACO group" is comprised by three pharmaceutical laboratories and
auxiliary plants in Tlajomulco de Zuñiga, Jalisco, México as following:
Until now, Laboratorios Salus was able to keep the prices at affordable level for lowincome population groups. Other producers of MDls with the majority foreign companies
(brand names MDl products), sell both CFC and non-CFC-based MDls, at prices -in
average-4 times higher than Salus.
The conversion of Salus to non-CFC based MDl products with the help of the Multilateral
Fund will allow the company to keep prices at affordable level for low-income population
and thus facilitating access to vital medication for millions of people. Thus, the
conversion of its current CFC-based production line to a non-CFC based one is of
strategic importance for the government owing to its contribution to the protection of
both, the population's health, in particular the millions of people suffering under
respiratory diseases, and the environment.
3
CFC used for the current production of MDIs in Mexico
Laboratorios Salus use an industry standard manufacturing process for the manufacture
of their MDIs, often referred to as “pressure filling”. All of the primary equipment
(Macromat etc.) was purchased in 1994 and is not suitable for retrofitting.
This process is dependant on a higher boiling point propellant (e.g. CFC-11), which is
both a good solvent (to dissolve the surfactant, e.g. oleic acid) and which can be
handled as a non pressurised liquid at room temperatures. No such propellant is
available as a non-CFC and therefore alternate manufacturing approaches will be
necessitated.
Currently the manufacturing capability at the Laboratorios Salus is based on a Pamasol
Macromat machine with an estimated (and observed at 44 c/p/m) maximum output of 45
canisters per minute, which based on single shift, 5 day operation with typical
efficiencies has a capacity in the region of 4.5 to 5.5 million units per annum. The year of
manufacture of the equipment is circa 1994.
One of the advantages of the use of the CFC-11, filled into an open canister is that the
propellant evaporates slowly producing a vapour more dense than air, which effectively
purges the canister of air, prior to placing the valve.
Currently Laboratorios Salus have a single Macromat based line, which has be
demonstrated to reliably operate at an output rate of 45 cans per minute. As part of the
overall program Laboratorios Salus shall be provided with two Macromat 2045 (or similar
machines) both capable of two stage filling. The later and larger Macromat 2045 is rated
at an output lower than that of the current machine. The two machines would operate as
a single line.
The approach will be to install, commission and validate the two Macromats in a double
configuration. These machines would be fed from the existing single can feeder and
cleaner and would discharge through the existing single check weigher and take off
table.
3
Appendix 1
4
The Scope of Contracting Services
Contractor, as the Equipment Provider, should have the necessary expertise and
experience to develop and produce automated equipment to manufacture CFC-free
(HFA) MDI's including providing support for the new equipment.
UNIDO shall enter into a contractual arrangement (or arrangements) for:
- Design, manufacture, testing, shipping, installation and commissioning of automatic
manufacturing equipment, specifically designed for the manufacture of HFA pMDI’s
at the Mexican Beneficiary company, i.e. Laboratorios Salus (see Annex 1).
5
Description of HFA MDIs to be developed
The following are the products, which are to be re-formulated as HFA MDIs.
Primary formulations
The MDIs below represent the main focus of the project.
•
Salbutamol 200 dose, 100 µg/ dose label claim of Salbutamol Base
(equivalent) from the valve (may be formulated using Salbutamol Sulphate
and/ or specified in an acceptable manner as the Dose ex mouthpiece if
agreed).
Unless otherwise agreed the reference product for determination of
equivalence shall be, GlaxoSmithKline Ventolin HFA
•
Beclamethasone dipropionate 200 Dose, 250 µg/ dose label claim ex valve
of Beclamethasone dipropionate( in the form of a recognised, salt, solvate
etc. If required) and/ or specified in an acceptable manner as the Dose ex
mouthpiece if agreed)
Unless otherwise agreed the reference product for determination of
equivalence shall be, TEVA Beclazone 250
Secondary formulations
Subject to acceptable terms from the invitee the following MDI shall also be included in
the scope of this project.
•
6
Beclamethasone dipropionate 200 Dose, 50 µg/ dose label claim ex valve of
Beclamethasone dipropionate( in the form of a recognised, salt, solvate
etc. If required) and/ or specified in an acceptable manner as the Dose ex
mouthpiece if agreed)
Unless otherwise agreed the reference product for determination of
equivalence shall be, Laboratorios TEVA Beclazone 50.
The key transition program steps for technology transfer for
Laboratorios Salus
4
Appendix 1
The equipment supplier shall provide technical support during the build, testing and
installation of the equipment and shall provide formal documented training at the
manufacturing site. After installation and commissioning is complete the contractor shall
guide the Mexican experts on the Installation Qualification (IQ), Operational Qualification
(OQ), Performance Qualification (PQ).
Because of the specialist nature of the CFC-free (HFA) MDI manufacturing
equipment, the required equipment shall be built and test run at the equipment supplier's
factory (Factory Acceptance Tests, FAT) before being dismantled, parts labeled to facilitate
reassembly, and shipped to Laboratorios Salus, as per their request. In addition, the
equipment supplier shall also oversee installation and commissioning of the equipment
at Laboratorios Salus, and conduct "Site Acceptance Test Trials" (SAT).
All the new equipment shall be installed by the equipment manufacturer. The equipment
supplier shall also provide technical support during the building, testing and installation of
the equipment and shall provide formal documented training at the manufacturing site at
Laboratorios Salus. Service contracts shall be negotiated prior to placement of any order
to ensure ongoing technical after-sales support.
The following are the key activities, which shall be incorporated in to both planning
activities and agreements on milestones.
•
Agree specific terms of reference for equipment, in respect of fittings, supply
requirements, environmental requirements, target operating outputs, assessment
criteria etc.
•
Review of proposed manufacturing area layout, service provision points, access
•
Manufacture and acquisition of all equipment specified in Annex 1 or
subsequently agreed equivalent specification for Laboratorios Salus
•
To conduct a Factory Acceptance Test (FAT) at the place of manufacture of the
equipment to demonstrate the capability of all elements of the equipment to
operate to the agreed specifications.
•
To ship all of the equipment to Laboratorios Salus.
•
To install the equipment in the agreed area prepared by Laboratorios Salus and
ensure that all supplies etc. are suitable for the operation of the equipment.
•
To conduct a Site Acceptance Test (SAT) at Laboratorios Salus to demonstrate
the capability of all elements of the equipment to operate to the agreed
specifications.
•
Supply all supporting equipment data in a form suitable to support submission to
Mexican Health Authorities for marketing approval.
6.1
•
Responsibility of Contractor
Agree specifications for an aerosol filling manufacturing line comprising two single
Aerosol Pharma Filling machines. Each of which has a capacity (for fill volumes of 18
<= 18 ml) of 30 to 40 cans/minute when filling in two stages (including ethanol)
5
Appendix 1
•
•
•
Machines shall have the capability of future upgrade to single stage filling with the
procurement and fitting of additional equipment.
Manufacture, install and commission the double production line, to include Factory
Acceptance Tests (FAT), shipping and Site Acceptance Tests (SAT).
Provide technical input to the generation of local documentation associated with the
equipment, training manuals, Cleaning SOP’s Validation protocols.
To work with the selected Technology Transfer provider and Laboratorios Salus, to
ensure the accuracy of any generated program plans/ timelines.
Contractor shall also assist in an advisory role to Laboratorios Salus in preparing their
production facilities for the conversion to HFA MDIs.
Any construction work and services required to accommodate and operate the
equipment for the new CFC Free MDI aerosol technology shall be carried out by
LABORATORIOS SALUS or their local contractors. The specifications for any
construction work shall be coordinated by LABORATORIOS SALUS and built by a local
construction company, as directed by LABORATORIOS SALUS after project approval
and as an outcome of the necessary site inspection and related discussions between
LABORATORIOS SALUS staff, and Contractor and UNIDO project personnel.
LABORATORIOS SALUS shall be responsible for all the construction and related
engineering work required to adapt the plant to suitable standards requirements of the
HFA filling line. LABORATORIOS SALUS is committed to ensure in a period no longer
than 6 months the preparation of a plant complying with all the specifications of space,
temperature, humidity, electricity and other requirements required by the Technology
Provider to produce HFA MDI. LABORATORIOS SALUS shall be responsible for funding
this aspect of the Project.
Under the proposed agreement, Contractor shall assist in an advisory role to
LABORATORIOS SALUS in the building of a custom designed Current Good
Manufacturing Practice ("cGMP") facility that shall be situated at LABORATORIOS
SALUS existing sites. The production facilities, including the design and operating
parameters shall be capable of meeting GMP and the requirements of the Mexican
regulatory body. The Contractor shall be responsible for advising and vetting the main
engineering, design, build and construction of the new manufacturing site/area. It is
intended that the Engineering Contractor shall be contracted individually by
LABORATORIOS SALUS and be directly responsible to LABORATORIOS SALUS. A
physical check of the site including a review of the existing utilities shall be performed as
soon as possible. This check shall ensure that all required services for the new
equipment and facility are of adequate capacity and design. A Health and Safety, and
Environmental review shall ensure that the design process has considered all aspects of
health and safety in relation to equipment design and installation.
The facility shall be built by LABORATORIOS SALUS acting through its subcontractors
and Contractor shall provide overall project management support and assistance, where
the planning activities fall within the scope of the CFC replacement program.
6.2
Responsibilities of Laboratorios Salus
6
Appendix 1
•
Agree specifications for an aerosol filling manufacturing line comprising two single
Aerosol Pharma Filling machines. Each of which has a capacity (for fill volumes of
18 <= 18 ml) of 30 to 40 cans/minute when filling in two stages (including ethanol).
•
To ensure that the manufacturing area to receive the manufacturing
equipment is prepared in accordance with the needs agreed in the
specifications, with respect to supplies of services, area, access etc.
To provide all materials required to facilitate pre-FAT, FAT and SAT
activities, on a free of charge basis.
•
6.3
Deliverables
The following deliverables to be provided by Contractor(s):
•
•
•
•
Manufacturing equipment in line with the example set forth in Annex 1.
All documentation in relation to operation, setting, maintenance of the equipment.
Technical training for Salus employees with responsibility for use and operation
of the equipment.
Warranty/ technical support for the equipment for a period of one year from
installation (for equipment failure excluding wear and damage)
7. Schedule of Project
Commencing as soon as can be practically agreed between the Parties and
predicated on equipment delivery times from the equipment supplier, the following represent
anticipated timings for key milestones.
Adaptation of plant and installation of the equipment:
9-11 months
Validation of equipment/ processes
Industrialization and scale-up batches
2 months
1 month
Generation of stability data and submission data
7 months
Filing and obtaining registration to produce in Mexico:
7 months
The proposed schedule of the Project shall be detailed and form an appendix to the final
commercial contract.
Monthly reports should be issued by contractor(s) to show progress during the project
development and to ensure timelines are adhered to.
Monthly reports should be issued by contractor(s) to show progress during the project
development and to ensure timelines are adhered to.
A plan in sufficient detail to identify clearly key milestones including;
·
Agreement of specifications
·
Completion of equipment
·
Factory Acceptance Trial
·
Preparation for shipping to client
·
Shipping to client
·
Installation and commissioning
7
Appendix 1
·
Site Acceptance trials
·
Completion of all training and formal equipment handover
7
Personnel in the Field
Contractor shall advise on Contractor’s personnel to be assigned by Contractor and their
qualifications requirements (CVs).
Also an estimated number of man-months are to be provided by Contractor in the field
and in the home office with the cost breakdown for such services.
8
Language requirements
The working language of the Contractor should be English. However, Contractor is
allowed to use personnel with a working knowledge of Spanish. An interpreter shall be
assigned by Laboratorios Salus at their own costs.
8
Appendix 1
9
Table of Scope of Supply
The table below represents a summary of the costing data required as a minimum from
the invitee.
UNIDO RFP reference No.
MP/MP/07/005 REQ.
Scope of supply
UNIDO REQUIREMENTS
Name and required
Item
parameters
I.
TO BE COMPLETED BY THE INVITEE
Unit
Total item
price
price
Compliance Remarks**)
Quantity
Currency Currency
Yes/no
Equipment costs
1 Supply of MDI manufacturing
equipment for Laboratorios
Salus: Single Aerosol Pharma
Filling Line with two double
stage fillers; Capacity: with
dosing valve 60 -70
cans/minute as per line
depending as well as on the
volume and valve to be filled;
suitable for 2-stage formulations
only (including the capacity for
single stage filling)
2 FAT activities
3 Shipping, insurance, etc.
4 Installation SAT activities
including training
1
1
1
1
Total price (1 + 2 + 3 + 4)
10
Evaluation criteria
•
•
•
•
The following represent the criteria that will be referred to for the
consideration of the content of offers received from invitees. It is
therefore advantageous that invitees use every opportunity to include
such information in their proposals in a clear and concise manner in
order to facilitate this review.
Compliance of the offer with the requirements in the TOR
Contractor’s demonstrable experience in similar projects in the last
five years
Knowledge of IQ, PQ and OQ and operation to recognized quality
9
Appendix 1
•
•
•
systems.
Demonstrable knowledge of operation within cGMP environments.
Demonstrated understanding of the requirements of program
management reflected in the level of the outline plans provided.
References from clients in receipt of successful HFA MDI commercial
products.
10
Appendix 1
ANNEX 1
PROPOSED EQUIPMENT REQUIRED TO BE PURCHASED FOR THE
MANUFACTURE OF HFA MDIs AT LABORATORIOS SALUS
Aerosol Pharma Filling Line Type: Double Macromat P 2045 configured to be
able to run two machines for filling in two stage mode.
Theoretical capacity two stage filling: with dosing valve 50 - 80 cans/minute,
depending on the feed rate of cans to the machine, rate of off-take via check
weigh station and unload and depending as well as on the volume and valve to
be filled.
Theoretical capacity one stage filling: with dosing valve 35 - 40 cans/minute,
depending on the feed rate of cans to the machine, rate of off take via check
weigh station and depending as well as on the volume and valve to be filled.
Installation: Zone 1
Standard Electricity supply in Mexico is 127 Volts, alternating at 60 cycles per
second.
The proposed layout is shown in the figure below.
11
Appendix 1
It is the intention that the equipment provided will be commissioned for a two
stage filling operation, with the solution/ suspension being fed from the existing
CFC-11 mixing vessel. The equipment provided should have the capability for
the future conversion to single stage filling with the procurement, installation,
commissioning and validation of appropriate equipment.
The equipment profile outlined below is for reference and provided fully justified
alternate equipment may be proposed which meets or exceeds the required
technical and quality requirements.
Description
Conveyor Belt P 30000/008
Length: 6.0 m consisting of:
- conveyor frame and guide rail stainless steel, slat
chain to suit double track Delrin, - coupling/ splitter
to suit existing single conveyers from can cleaner.
- conveyor supports height adjustable
- drive unit and return section, motor foreseen to be
controlled by frequency inverter
Can Divider X30000-054 (66203)
Can conveyor X30000-0054-010/001 (66882)
Ejector for lying cans X30000-0054-020 (66473)
Hinged top cover in Plexiglas
Set of special tools
Set of spare parts
Lifting tables to absorb the contact pressure of the
Crimpers
Macromat P 2045/016 for two stage process
Basic installation
Quantity
1
1
1
1
1
1
1
1
2
with automatic rotary table, ¨ 600 mm and 18-pitch
infeed starwheel with quick changeable can guides
for cans with a ¨ up to 66 mm.
The pitch circle allows the installation of 1 - 3
product fillers, 1 valve inserter, 1 crimper and 1 - 3
propellant fillers. The bracket with the filling heads is
fitted to the central column. Joint adjustment of the
working height for the filling heads and the crimper.
After the adjustment an automatic locking system
keeps the bracket with the filling heads in position.
Cans with a height up to 330 mm can be handled.
12
Appendix 1
Entirely pneumatic operation. An interlock system
controls the return of the filling head and the
synchronisation of the indexing mechanism.
The control panel allows the individual operation of
all aggregates. This guarantees the function and
control of each movement. A can counter with zero
setting is integrated.
The distribution of compressed air with the filter
regulator and an automatic lubricator are installed in
the base of the machine. The base and the top of
the machine form a silencing housing. Removable
panels and doors allow an easy access to all
aggregates.
The complete cladding is made of stainless steel.
Frame and brackets in stainless steel AISI 304
- 400 mm deep back cabinet
Skirt around machine
2
2
Set of can guides for one diameter
2
Pneumatic height adjustment, with air motor,
adjustable by push button
2
Extraction duct device for product or propellant
vapour (without ventilation)
Hepa filter not included!
2
Protection guard “SYMA” with aluminium frame
and security glass. The doors are equipped with
turn locks
2
Control switches “door open - machine stops”.
Interrupting the working process. Restart after
closing of the door and confirmation
8
Set of spare parts
2
Product Filler P 2001/021
Article consisting of:
Quick release bracket for metering units
Modular sub base mounted, oilfree pneumatic
control system
Slave cylinders with quick release couplings for
filling nozzles
P 2001 5 ml metering units Diaphragm inlet shut off
valves
2
13
Appendix 1
Diaphragm outlet shut off valves to enable
recirculation
Diaphragm filling nozzles
Quick release couplings for nozzles
Product contact parts of 316L stainless steel
Description:
1 Product Filler P 2001 - 5 ml
The suspension/solution filling station meters a preset volume of solution into the open can.
The metering unit is mounted on bracket and a filling
nozzle which is attached to a slave cylinder. The
product is supplied to the metering unit via the inlet
shut off valve. The product then passes through the
metering unit and down to the diaphragm filling
nozzle.
Product supply: the 5 ml filler has to be connected to
a feeding pump.
Set of spare parts
SSP Lobe Pump X1/0005/HO8 Incl. movable base
Rotary piston pump (3 Lobe) with safety valve in
pump top with motor and gear
- Suitable for recirculation system
- Housing, shaft and rotors made of stainless steel
316 L
- Speed of rotation: 690 rpm
- Pressure pump outlet 2.5 bar
- Quantity 0.5 m3/h
- Inlet pressure 0.5 m
- Pump connection: Entry DN 25 Clamp Outlet DN
25 Clamp - FDA conform
Valve Inserter P 2058
For 20 mm valves without dip tube.
Set of spare parts
Vacuum Crimper P 2002/021
Oil-free execution
The vacuum is used depending on the desired
formulation to be filled. For single stage HFA
formulations however is vacuum required.
When vacuum is selected the station pulls a vacuum
in the can before crimping the valve collar onto the
can. A bulging seal fitted to the base of the head
seals the vacuum bell around the can. The valve is
then lifted off and vacuum is pulled. Then the valve
is replaced on the can, the gasket compressed and
the valve collar is crimped.
2
2
2
2
2
14
Appendix 1
Diaphragm Filler P 2079
The diaphragm propellant/suspension filling station
meters a preset volume of suspension/solution
through the crimped valve into the can. After the
filling any residue of suspension/solution contained
in the filling nozzle and the valve stem is sucked
away, thus avoiding contamination in the enclosure
and on the can. To protect the vacuum pump the
remaining product is filtered with the CUNO-filter.
The suspension/solution is supplied to the metering
unit via the inlet shut-off valve. It then passes
through the metering unit and down to the aspirator
filling nozzle. It recirculates through the filling nozzle
back through the outlet shut-off valve before
returning to the mixing vessel.
The filling head consists of a diaphragm metering
unit and an aspirator filling nozzle attached to a
slave cylinder.
The metering unit uses only diaphragm metering
chambers and diaphragm inlet and outlet valves to
eliminate any reciprocating seals which can be
prone to attack by HFA suspensions.
Additional filling heads incl. filling head insert
Set of special tools
Set of spare parts
Rotary vane vacuum pump Busch R5 P 14012
Type 040-132 for automatic installations
The pump shall be connected with a hose either to
the vacuum unit P 2044 or the vacuum crimping
head
2002-150/5.
Suction capacity: S = 40 m³/h
Final vacuum: p = 20 mbar
Motor: 1.3 kW, 3x190-210/380-420V, 50 Hz
1.5 kW, 3x190-240/380-480V, 60 Hz
Cuno Filter type CT 100 A V 12098/02
Suitable for semi-automatic installations. Standard
execution short 124 mm,
with connection ½", incl. 1 filter cartridge,
air exhaust valve 1/8" and ring spanner to open the
filter.
Filter cartridge V 12098/02-01
Valve Sorting System Type RNA consisting of:
Vibrator drive, base plate and frame, control box,
vibrator bowl, connection plug, solenoid valve, bowl
metaline covered.
2
4
2
2
2
2
2
1
15
Appendix 1
Dust and noise protection System
Valve Transport system X02047-038… with chain
conveyor "Paternoster"
Suitable for 20 mm valves.
The aerosol valves are transported from the sorter
to the inserter by a rail system.
A drive unit brings the valves up to a height of 2.5 –
3.0 m, where they enter a telescope system before
reaching the inserter. This system allows an easy
adjustment to the individual can height. This unit is
fully controlled by fibre optics.
Divider to feed two Macromats is included.
Can Merging Device
Mixing and Preparation Vessel
- Capacity: 15 litres
- Working pressure: 6 bar
- Test pressure: 9 bar
Option:
- Additional price for ex-zone 2 CHF 9820
Set of spare parts
Hoses and Connections
Declaration of conformity according to CE standards
for equipment with pressure. (Pressure Mixing
Vessel) Issued by TUV. Radiographic controls and
pressure tests
Propellant Pump P 2008/03
Oilfree operation
This pump guarantees a regular pressure of
propellant
in its metering cylinder. The gas pressure can be set
by changing the control pressure of compressed air.
All parts in contact with the propellant are made of
stainless steel, AISI 316L.
All commercial propellants such as HFA and CFC
can be transferred with this pump.
The feed pressure is max. 20 bar (300 psi). The
pump operates pneumatically.
Inlet filter V 12021/1
Inlet hose Z 18620-1070
Connection hoses Z 18620-2000, between:- pump
and CUNO-Filter- CUNO-Filter and filling machine
length 2 m each
Set of spare parts
1
1
1
1
1
2
1
2
2
2
4
1
16
Appendix 1
CUNO-Filter type CT 100 A V 12098/02Suitable for
semi-automatic installations. Standardexecution
short 124 mm, with connection ½", incl.1 filter
cartridge, air exhaust valve 1/8" and ringspanner to
open the filter
Filter cartridge V12098/02-1
Electrical Equipment
1. General
- The main control cabinet for the line has to be
placed in the safe area.
- The line needs a power connection of
3x400V+N+PE, 60 Hz. The voltage and the
frequency can be changed to the customer's
requirements.
- The control circuit voltage is 24 VDC.
- The necessary control equipment and the basic
operator interfaces are built on.
- The line conforms to the specifications for
electrical equipment of industrial machines.
(International Electrotechnical Commission
"IEC204")
2. Main Control Cabinet
- The main control cabinet has three parts: power
circuit, control circuit and EExi parts.
- The main control cabinet contains:
Main switch, maintenance switch, main contactors,
contactors, motor starters, circuit breakers, terminal
fuses, power supply, safety relays, thermistor
control relays, terminals etc.
- Rittal control cabinets painted execution (Pharma
stainless execution)
- Mitsubishi, Siemens or AllenBradley PLC
Mill Sheets
Certificate for pressure gauges
Supply of all documentation in Spanish
Equipment validation documentation in Spanish
Equipment commissioning, installation and training
2
10
1
234
2
1
1
1
17