O V E R V I E W
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WipeDown 10
®
A Superior Methodology for Performing Compliant
70% IPA Saturated Wipe Downs in Aseptic Processes
9 Class 10 Cleanliness
9 Residue Removal Enhancements
9 Superior Sorption Characteristics
9 Laser Cut Sealed Edges
9 Laundered
9 Low Particulates and Extractables
9 Validated Sterile to 10-6 SAL
9 Particulate Entrapment Features
A Quality Choice from the Innovators in Clean Room Technology!
Veltek Associates, Inc.
15 Lee Boulevard • Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] WD-01 Rev3: 20NOV2009
O V E R V I E W
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Performing a Compliant Wipe Down of
Process Equipment. What is the Correct
Procedure?
Performing a 70% IPA post or pre-disinfection wipe
down of process equipment is sometimes done
incorrectly. Many industry personnel will utilize a
saturated wipe to perform this function. This procedure
is incorrect and will net little if any success in removal
of the residue.
In review of the available mechanisms, one must
understand that 70% IPA wipe downs are performed to
do several things.
1.
2.
Clean the surface of resident residual and
particulates
Possibly destroy and remove very low levels
of vegetative microbial contaminants such as
Staphylococcus species.
Sanitizers, Disinfectants and Sporicides used to
disinfect surfaces leave residues. These residues, if left
remaining on critical, close to product contact surfaces
can be a source of contamination to the product contact
surface. The contamination may not be microbial but
may be chemically related or particulate related.
When residues are left on the surface they are in a dry
state. To remove the residue, one needs to first provide
a mechanism whereby the residue can be put back into
solution or softened therefore lifted from the surface.
Saturated wipes do not accomplish this task. Why?
The saturated wipe does not contain enough 70% IPA
nor a long enough contact time to put a dried residual
back into solution. And then, the saturated wiper
cannot lift the contaminated liquid with residue from
the surface as its absorbency is loaded with 70% IPA..
The saturated wipe’s absorbency capabilities in an
already wetted state do not have the ability to soak up
the contaminated liquid. Thus, the saturated wiper just
moves around the contamination. In doing this,
cleaning is not performed and residue build up can
further cause contamination problems.
Contamination problems from remaining residual on the
surface can also further complicate product contact
surfaces over time in many other ways. A residue laden
surface is more likely to vest particulates, fibers,
pyrogens and viable contamination (as actives in the
disinfectant no longer exist). In short, the residual
should be removed to assure a safe and compliant
surface for close to product contact surfaces.
What is the Best Method for Cleaning
Surfaces?
Performing a 70% IPA post or pre-disinfection wipe
down of process is done to clean the surface. Isopropyl
Alcohol at 70% has little if any antimicrobial
capabilities against the broad spectrum of viable
contamination that may be found in the clean room. Per
many writings that include Seymour Block’s,
“Disinfection, Sterilization and Preservation, 4th
Edition”, 70% IPA’s antimicrobial capabilities in a 30,
60 and 90 second dry time period can only have affect
on minimal levels of certain staphylococcus,
micrococcus and streptococcus to name a few. In
evaluation f the required dry or contact time periods, we
notice that 70% isopropyl alcohol needs a minimum of
1 minute to be effective to any degree. With saturated
IPA wipes, the dry time is very short ranging a few
seconds to possibly 15 seconds at best. And thus, kill is
minimal.
This data provides us with the framework to understand
that the 70% IPA wipe down is a cleaning step.
To perform an IPA wipe down correctly, the following
procedures should be followed.
1.
2.
3.
The surface should be disinfected prior with an
approved disinfectant or sporicide.
Upon completion of the required and validated
dry time period, an IPA wipe down should be
performed.
The IPA wipe down should include a spray
down of the surface with 70% IPA (such as
DECON-AHOL WFI) and then wiped while
wetted with a folded in half the WipeDown 10
wipe. Upon completion of the first wipe the
wipe can be turned over and the surface wiped
again.
This procedure will net the removal of possibly existent
particulates, foreign matter, residues and
microorganisms that may be present on the surface.
By use of the absorbent, sealed edge, laundered
polyester WipeDown® 10 and the procedure above
surfaces will look noticeably cleaner in 1-2 weeks.
To protect stainless steel from corrosive disinfectants,
consider Veltek’s STEEL-BRIGHT® Sterile stainless
steel cleaner and protectorate.
Veltek Associates, Inc.
15 Lee Boulevard • Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] WD-01 Rev3: 20NOV2009
O V E R V I E W
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WipeDown 10
®
The Superior Methodology for Performing Compliant 70% IPA Wipe Downs
Sterile and Non-Sterile
Product Description:
WipeDown® 10 is a superior dry cleaning wipe used for aseptic IPA wipe downs of filling and packaging
machinery, stainless steel surfaces, lexan, polycarbonate, glass and any critical surface requiring to be cleaned. The
wipe is a laundered polyester dry wipe that incorporates Class 10 cleanliness and sealed edges. WipeDown ® 10 is
manufactured from 100% continuous filament polyester double-knit interlock. It is chemically engineered to
achieve maximum cleanliness features and sorbency. The edges have been laser cut leaving no abrasive borders
reducing particles and shedding from the edges. The wipe is available in a 12" X 12" size both sterile and nonsterile. The sterile version is terminally sterilized and each order is delivered with the lot specific Certificate of
Irradiation and Certificate of Sterility (current USP compendium). The material used in the product is a 100%
continuous polyester fiber that is especially clean and absorbent. Particulate, residues and foreign matter are
effectively entrapped in the webbing of the material. The knit construction and pattern has been developed to ensure
the greatest product integrity and cleaning performance. The edges are laser cut and sealed. WipeDown 10 clean
room wipes are extremely low in particle shedding and soluble extractables. They are laundered in ultra-filtered
water of 0.45µ and dried in a HEPA filtered Class 1 air stream. Each wipe is inspected and hermetically sealed in
ultra clean packages within class 10 conditions. WipeDown 10 clean room wipes are your choice to meet the
highest cleanroom standards.
Ordering Information:
Order#
Description
VEL8-12X12-S-3001 WipeDown® 10 Dry Wipe Non-Sterile - 20 wipes/bag, 5 bags/pouch, 6 pouches/case
VEL8-12X12-S-3002 WipeDown® 10 Dry Wipe Sterile - 20 wipes/bag, 5 bags/pouch, 6 pouches/case
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Veltek Associates, Inc.
15 Lee Boulevard • Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] WD-01 Rev3: 20NOV2009
O V E R V I E W
4
WipeDown 10
®
SPECIFICATIONS
Ingredients:
Fibers:
Fiber Length:
Physical Properties:
Color:
Basis Weight: IES-RP-CC 004.3
Thickness:
Absorbency: IES-RP-CC 004.3
Nonvolatile Residue, NVR, IES-RP-CC 004.3
Ion Content: IES-RP-CC 004.3
Release of Particles:
Particle Charge:
Classification:
Results:
100% Knitted and Laundered Polyester, Laser Cut Edges
Continuous
White
130 + 5 gsm
0.56-0.64 mm
Sorptive Capacity: 497 mL/m2 Rate: 0.5 sec
IPA Extractant (100 mL IPA at Ambient Temp for 24 hrs:
0.20 mg/g
DIW Extractant (100 mL DI Water at Ambient Temp for 24 hrs:
0.10 mg/g
Anion:
Chloride (Cl): 0.0003 mg/g
Sulfate (SO4): 0.0003 mg/g
Cation:
Ammonium (NH4): 0.0003 mg/g
LPC (> 0.5 um) IES-RP-CC 004.3: 2.99 x 106 paricles/m2
APC (Dry Test: Helmke Drum) IES-RP-CC 003.2: 15 counts/pc/cfm
Positive
Class 10 (M2.5) Cleanroom Applications
GENERAL PRODUCT PACKAGING/FILLING SPECIFICATIONS:
PRODUCT LOT NUMBER:
Product Lot Number is placed on each wiper package and on the exterior of the
case.
IRRADIATION LOT NUMBER:
Irradiation Sterilization Lot Number appears on the exterior of the case and on
the certificate of irradiation. Dosage is Min: 10.0 kGy Max: 20.0 kGy
PACKAGING:
Product is bagged in groups of ten (10) wipes in a 4 mil nylon bag and then
placed into intermediate bulk pouch of ten (10) wiper bags (100 wipes,10/bag).
Six (6) wiper pouches (containing 100 wipes, 10/bag) are then placed into a
lined case. This forms a triple bag presentation for easy transfer to aseptic
areas. The entire contents are then irradiated.
STERILITY TESTING:
Once irradiation treatment has been accomplished, the product undergoes 14
day USP <71> Direct Transfer Method in TSB (Trypticase Soy Agar) and
Thioglycollate Media. (20 samples/lot)
EXPIRATION:
Expiration is 2 years from date of manufacture.
DOCUMENTATION:
Deliver with the Lot Specific Certificate of Analysis, Certificate of Irradiation,
and Certificate of Sterility.
Veltek Associates, Inc.
15 Lee Boulevard • Malvern, PA 19355-1234
Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] WD-01 Rev3: 20NOV2009