Veltek Associates Catalog

Transcription

TABLE OF CONTENTS
7
SCMDSTERILE CHEMICAL MANUFACTURING DIVISION
81
CORE
84
ECMDENVIRONMENTAL CONTROL MONITORING DIVISION
111
DPMDDISPOSABLE PRODUCTS MANUFACTURING DIVISION
126
VAI® LABORATORIES
128
CORE2CLEAN® PLUS SYSTEMS
132
A P I ® ( C O N S U LT I N G ) D I V I S I O N
C O M PA N Y AT A G L A N C E
FOUNDED:
HEADQUARTERED:
1981
MALVERN, PENNSYLVANIA (SUBURBAN PHILADELPHIA)
CUSTOMERS:
MORE
EMPLOYEES:
120
KEY BUSINESS LINES:
VAI LABORATORIES:
THAN
300
COMPANIES WORLDWIDE
STERILE CHEMICALS & DISINFECTANTS, MICROBIAL AIR SAMPLING,
CLEAN DISPOSABLE GARMENTS, STERILE INGREDIENTS, CONSULTING
IN-HOUSE
TESTING
&
WEB SITE:
WWW.STERILE.COM
PHONE:
1-888-4-STERILE
RESEARCH FACILITY
I N N O VAT I V E S O L U T I O N S Y O U C A N T R U S T
Every day, the people of Veltek Associates, Inc.
make amazing things happen—from revolutionary
discoveries to exceptional customer service to
consistent, quality manufacturing. As a result,
we remain the clean room industry’s most trusted
source for innovation, quality and service…
w w w. s t e r i l e . c o m
1
For more than 30 years, Veltek Associates, Inc. (VAI), headquartered in Malvern, Pa., has pioneered the design and manufacture
of hundreds of clean room solutions. These innovations, many of them landmarks in the industry’s history, allow our customers to
overcome challenges and reach their business goals. Plus, VAI clients have more than a solutions provider; they have a partner
and trusted advisor. And with today’s complex research challenges, new competition and increasing government regulations, a
true partnership is more important than ever.
2
1-888-4-STERILE
1-888-478-3745
In 1981, Arthur L. Vellutato, Sr. founded VAI after 25 years in the pharmaceutical industry. VAI made an immediate contribution
to the industry as the first to manufacture disposable garments from start to finish in a clean room environment. Since then, VAI’s
product line has diversified significantly, enabling us to find solutions for many types of contamination, in many industries. Our
divisions include sterile manufacturing chemicals, environmental control monitoring, disposable products and VAI Laboratories
which provides our customers with microbiological testing services ranging from the identification of microorganisms to antimicrobial effectiveness studies. In addition, Aseptic Processing Inc. (API) offers our customers a customized consulting solution to aid in
their most difficult of needs.
We invite you to learn more about VAI’s products and services, and see for yourself what makes us the most innovative and
responsive provider in the industry. Whether you are looking for the tried-and-true products that helped build your business or
looking to develop something brand new, VAI provides innovative solutions you can trust.
3
A H I S T O R Y O F I N N O VAT I O N
For us, it’s simple. Innovation is about listening to industry challenges and
not stopping until we find the answer. Together with our clients, we’ve been
developing new solutions for the clean room industry for more than 30 years.
Our products and services have allowed our clients to do remarkable things—
from biotechnology breakthroughs to pharmaceutical discoveries that help millions
of people every day. From our early days developing the first sterile garments
to our latest innovations, VAI develops products that revolutionize and simplify
aseptic manufacturing. We encourage you to discuss your needs with our
technical representatives by calling 1-888-4-STERILE.
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1-888-4-STERILE
1-888-478-3745
5
K N O W L E D G E , E X P E R I E N C E A N D PA R T N E R S H I P
More than 500 pharmaceutical, biotechnology
and healthcare clients around the world
turn to VAI because we understand the
challenges they face. Our experience and
unsurpassed technical expertise means
“real-world” solutions from people who
have worked in the industry. And, because
our product line is so extensive, a relationship
with VAI means a more cost-effective way
to buy clean room products.
At VAI, we develop our products in an environment that mimics your environment
providing a seamless development process that ensures accuracy and precision.
And when you work with us, you get recommendations from technical experts
who have extensive industry experience, not salespeople. This means you get
exactly what you need, and nothing you don’t.
About VAI Laboratories
Complete and documented efficacy performance and testing to prove the
removal of existent contamination is a very costly and time-consuming task.
Hence, VAI has responded by establishing VAI Laboratories, a GLP microbiological
testing facility capable of performing time contact kill studies, disinfectant
validation services and microbe identification. In addition, the VAI Laboratories
staff, who work daily in GMP settings, will consult with each client to ensure
they achieve best-in-class clean room operations and contamination control.
These value-added services provide our clients with timely advice and proven
solutions, all within the framework of regulatory requirements.
Learn More
At VAI, we strive to develop meaningful, long-term relationships with our clients
to help reduce expenses, eliminate waste and simplify manufacturing. Plus, our
products are designed to build upon each other, so as you grow, you know you
can count on us. Call us today at 1-888-4-STERILE or visit www.sterile.com.
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1-888-4-STERILE
1-888-478-3745
Sterile Chemical Manufacturing Division
WELCOME TO SCMD
STERILE CHEMICAL MANUFACTURING DIVISION
T
he prior removal of contaminants, both viable and non-viable, in solutions to be used within the aseptic
SCMD
manufacturing operation is essential in assuring the control and integrity of the environment.
VAI’s Sterile Chemical Manufacturing Division (SCMD) has addressed the needs of the Pharmaceutical and
Biotechnology industries by designing a complete range of sterile chemicals and disinfectants for the aseptic
manufacturing area. VAI’s SCMD products are used at over 500 Pharmaceutical and Biotechnology
organizations worldwide.
VAI’s SCMD manufacturing operations mirror Current GMP’s and enforces the complete adherence to USP
specifications for testing of all manufactured products.
SCMD occupies a majority of the square footage of the Malvern, PA facility and manufactures a complete range of
sterile chemicals and disinfectants that are used daily in operations. All VAI manufacturing operations are
completely validated and routinely revalidated to assure product integrity. VAI capabilities for manufacturing
products include the ability to fill aerosol, bulk and unidose packages in a aseptic filling operation. Our aseptic
filling operations are coupled with the validated and proven ability to irradiate a final product. Assurances are taken
in every aspect of SCMD concerning sterility and particulate removal.
SCMD has taken another step in product quality assurance by incorporating USP Water for Injection (WFI) into all
of our products. The established WFI systems in our SCMD facility incorporate an added advantage to the
manufacture of our products. The mission of VAI’s SCMD is to provide either a pyrogen free product where desired
or a pyrogen reduced product where raw materials that must be incorporated have the inability to be processed as
pyrogen free.
SCMD has manufacturing capabilities to produce both VAI products and custom contract manufacturing designs.
In recent years, VAI has been asked by many Pharmaceutical and Biotechnology operations to manufacture raw
materials for use in their operations. VAI’s SCMD uncompromising cGMP manufacturing style and our complete
adherence to USP specifications have assured outside organizations that their products will not only be produced
and tested as sterile, but moreover, their product will be completely documented and validated. VAI’s SCMD is
proud of its history and track record.
VAI’s SCMD® products include DECON-AHOL® WFI Sterile, STER-AHOL® WFI Sterile, DECON HAND®,
DECON-PHENE®, DECON-PHASE®, DECON-CYCLE®, DECON-Clean®, DECON-QUAT® 100, DECON-QUAT® 200C,
DECON-QUAT® 200V, DECON-SOAP®, HYPO-CHLOR®, STERI-PEROX®, STERI-WATER®, VAI WFI QUALITY WATER,
DECON-SPORE 200 Plus®, DECON-Class®, STERI-OIL® 200, STERI-SILICON®, STERI-BUFFER®, STEEL-BRIGHT®, the
SIMPLEMIX® product line, the Process2Clean® and Cage2Wash® product lines and our line of Sterile Wipes.
These products are described on the following pages.
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SCMD-STERILE CHEMICAL
M A N U FA C T U R I N G D I V I S I O N
SCMD
9-11
12-13
14
15
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
41
42
43
44
45
46
47
48
49
50
51
53
55
57
59
61
63
66
68
70
72
74
76
78
8
DECON-ASSURE® BIODECONTAMINATION PROGRAM
DECON-AHOL® STERILE WFI
STER-AHOL® STERILE WFI
SIMPLEMIX® SYSTEMS
DECON-HAND®
ASEPTI-CLEANSE®
ALCOHOL DISPENSERS
DECON-PHENE®
DECON-PHASE®
DECON-CYCLE®
DECON-CLEAN®
HYPO-CHLOR®
STERI-PEROX®
DECON-QUAT® 100
DECON-QUAT® 200 C
DECON-SPORE® 200 Plus
STERI-WATER®
WFI QUALITY WATER
STERI-BUFFER® 90 & 99
STERI-OIL® 200
STERI-SILICON®
STEEL-BRIGHT®
DECON-GLASS®
DECON-SOAP®
LABEL COLOR CHART
WIPEDOWN® Dry Wipe
PROCESS2WIPE® IPA70
PROCESS2WIPE LC® IPA70
HYPO-CHLOR® WIPE
DECON-CLEAN® WIPE
STERI-PEROX®WIPE
ALCOH-WIPE®
ALCOHOL GLOVE® STERILE SINGLES
DAS-WIPE® 100
STEEL-BRIGHT®WIPE
WIPEDOWN® HC
PROCESS2CLEAN® 1
PROCESS2CLEAN 2
PROCESS2CLEAN 3
PROCESS2CLEAN 4
PROCESS2CLEAN 5
PROCESS2CLEAN 6
CAGE2WASH® 1
CAGE2WASH 2
CAGE2WASH 3
CAGE2WASH 4
CAGE2WASH 5
CAGE2WASH N
DECON-QUAT 200V
1-888-4-STERILE
1-888-478-3745
SCMD
DECON-ASSURE®
B I O D E C O N TA M I N AT I O N P R O G R A M
The DECON-Assure Biodecontamination Program has been developed to assist you in maintaining acceptable
environmental conditions while addressing the requirements of regulatory agencies. “Testing and Addressing”
contamination in a documented system is the goal of the DECON-Assure Biodecontamination Program. The following
is a brief summary.
CRITERIA #1: TEST AND ADDRESS CONTAMINATION:
Through one’s environmental monitoring program, one can develop a list of environmental isolates that have been noticed
in their operations. Once developed, the key is to successfully integrate and document a plan for assuring the demise of
these organisms.
CRITERIA #2: ANTIMICROBIAL EFFECTIVENESS STUDIES:
Determining what chemical agents will destroy a known level of one’s environmental isolates is the next step. Prior to
conducting either a Time Contact Kill Study (Tube Dilution), or a Time Contact Kill Study (On User Surfaces) or an AOAC
Protocol Study, one needs to review the available disinfecting agents and determine which is initially appropriate for their
operations. Upon choosing 1 or 2 disinfecting agents and a sporicide, one can continue with the antimicrobial effectiveness
studies. Antimicrobial effectiveness studies must be based on realistic bioburdens that may be noticed in the controlled
areas. It is normal to test an enumeration greater than or equal to 1.0 x 104 cfu’s. This testing will provide the justification for
utilizing the chemical agents.
CRITERIA #3: CHOOSING A
DISINFECTION SYSTEM:
Varying applications require various solutions to be in place. VAI has
established three (3) systems that will net success. The choice to use a
phenolic, quaternary ammonium or hydrogen peroxide delineates the
rotation parameters. The choice of one disinfectant and a sporicide is
completely appropriate, however, some may decide to rotate similar
disinfectants while also utilizing a sporicide.
9
SCMD
DECON-ASSURE®
(CONTINUED)
Rotation systems are designed to address known or possibly existent contamination with proven efficacious disinfectants.
The basis for the rotation of disinfecting or sporicidal agents is to address an organism that may not be destroyed by a
particular disinfectant with another that has proven efficacy performance against the organism. An example would be a phenol that may not kill a B. subtilis in a 5-10 minute contact time and thus the rotation to a more efficacious product such as a
sporicide may be warranted to destroy this organism. However, organisms do not develop an immunity or resistance to a
chemical agent over time. Scientific evidence of such occurrences has never been documented as factual in the clean
room. Thus, the basis for rotation is to address an organism that is not destroyed by, nor ever was destroyed by one
chemical agent, with another that has proven efficacy performance against such organism.
Destroying contamination in a clean room operation requires addressing the known vegetative cells and the spores. In
design of a rotation system, there are two types. 1) A single disinfectant rotated with a sporicide, and 2) A two disinfectant
system (rotated monthly) plus a sporicide. Either system requires, at minimum, a monthly sporicidal application. This may
be increased or decrease in time frames and will be determined by the environmental conditions. The use of DECON-Clean®
is considered an optional step in controlling existent residues and should be done at least once a quarter (suggested
monthly). DECON-AHOL WFI® or STER-AHOL WFI® should be used on process equipment as a final wipe down.
CRITERIA #4: CONDUCTING AN “IN-SITUATION FIELD STUDY”:
Once a disinfection system has been chosen and antimicrobial effectiveness testing has been completed, conducting an
“in situation field study” is important to prove the effectiveness of the combination of our cleaning SOP’s (standard operating
procedures) and our antimicrobial effectiveness testing. Simply, environmental monitoring (both air and surface) is conducted in a
dirtied room. Upon completion of the monitoring, the room is cleaned and disinfected per the current operating procedures.
Upon completion and drying of all surfaces, the room is monitored again. Satisfactory results need to be obtained in 3
different and separate in-situation field studies prior to acceptance of the disinfection system.
CRITERIA #5: UPDATING YOUR PROFILE:
As time progresses, it’s possible that organisms not previously tested may be noticed in operations. Antimicrobial effectiveness
testing should be performed on these contaminants to continue to prove and document the disinfection system as
validated to current operations. Changes over time may also occur in production scenarios, processes and personnel.
Reviewing SOP’s for cleaning and disinfection should be done routinely to address current situations.
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1-888-4-STERILE
1-888-478-3745
(CONTINUED)
SCMD
DECON-ASSURE®
DECON-ASSURE ROTATION SYSTEMS:
Month 1: Rotating One Disinfectant and a Sporicide
Day(s)
Phenolic
Day 1-13
Day 14
(if warranted
by EM data)
DECON-CYCLE
DECON-Clean® followed by
HYPO-CHLOR® 0.52%
or STERI-PEROX® 3% or 6%, or
DECON-SPORE® 200 Plus.
DECON-CYCLE
DECON-Clean followed by
HYPO-CHLOR 0.52% or
STERI-PEROX, or
DECON-SPORE 200 Plus.
Day 15-29
Day 30
®
Quaternary Ammonium
Hydrogen Peroxide
DECON-QUAT
HYPO-CHLOR 0.52% or
STERI-PEROX, or
DECON-QUAT
HYPO-CHLOR 0.52% or
STERI-PEROX, or
STERI-PEROX 3% or 6%
HYPO-CHLOR 0.52% or
STERI-PEROX, or
HYPO-CHLOR 0.52% or
STERI-PEROX, or
®
Month 2: Rotating Two Disinfectants with a Sporicide
Day(s)
Phenolic
Quaternary Ammonium
Hydrogen Peroxide
Day 1-13
Day 14
(if warranted
EM data)
DECON-PHENE
HYPO-CHLOR 0.52% or
STERI-PEROX 3% or 6%, or
DECON-CYCLE
HYPO-CHLOR 0.52% or
DECON-QUAT
HYPO-CHLOR 0.52% or
STERI-PEROX 6%
HYPO-CHLOR 0.52% or
HYPO-CHLOR 0.52% or by
DECON-SPORE 200.
DECON-QUAT
HYPO-CHLOR 0.52% or
Day 15-29
Day 30
After disinfection all critical surfaces should be rinsed with hot WFI or an IPA wipedown should be performed.
11
D E C O N - A H O L® W F I S T E R I L E
W F I F O R M U L A U S P I S O P R O P Y L A L C O H O L W I T H U S P W F I W AT E R
EPA Registered hard surface disinfectent and sanitizer.
SCMD
DECWFI-SP-70
DECWFI-TR-04
DECON-AHOL WFI Sterile Formula has been developed to address the reduction of possible
endotoxin levels that may exist in the use of a 70% sterile Isopropyl alcohol solution. VAI knew that
just formulating 99% isopropyl alcohol with USP Water for Injection (WFI) without the concern for the
reduction of endotoxin levels throughout the entire manufacturing process would net an
unacceptable final product. Therefore, after years of development VAI has assured not only the
formulation of the product with USP Water for Injection but also designed a system to assure a
closed system manufacture of the product. VAI has assured the lowest possible endotoxin level
making it an excellent choice for the critical aseptic manufacturing operation.
DECON-AHOL WFI Formula is:
• 70% USP Isopropyl Alcohol
• Formulated with WFI
• Filtered at 0.2 Microns
• Double-bagged packaged
• Gamma irradiated
• Completely tested according to current USP compendium
• Delivered with lot specific Certificate of Irradiation, Certificate of Analysis, LAL Testing Analysis
and Sterility Report
• Completely traceable
• Completely validated for sterility and shelf life
• Validated for a 3 year expiration of unopened product
• Available in Quadruple bagged ABCD® Clean Room Introduction System
USES: DECON-AHOL WFI Sterile Formula is used for the decontamination of items such as:
• Gloves
• Surfaces
• Carts
• Countertops
• Process lines
• Applications that require a sterile alcohol solution made with USP Water for Injection
DECWFI-SQ-16Z
Order#
DECWFI-B-70
DECWFI-SP-70
DECWFI-ST-70
DECWFI-SP-70-B
DECWFI-B-60
DECWFI-B-70
DECWFI-B-91
DECWFI-TR-04
DECWFI-TR-05
DECWFI-SQ-16Z
DECWFI-SQ-03
DECWFI-B-5G-70
DECWFI-BOT-01
DECWFI-BOT-02
Description
70%
70%
70%
60%
70%
91%
70%
70%
70%
70%
70%
70%
70%
Quan/cs.
Mist Spray Sterile, 11 oz. Aerosol
Stream Spray Sterile, 11 oz. Aerosol
Inverta Spray Mist, 11 oz. Aerosol
1 Gallon Sterile
1 Gallon Sterile
1 Gallon Sterile
16 oz. Trigger Spray Sterile (attached triggers)
32 oz. Trigger Spray Sterile (attached triggers)
16 oz. Squeeze Bottle Sterile (individually bagged)
16 oz. Squeeze Bottle Sterile (bulk packed)
5 Gallons Container Sterile
32 ounce bottle for Asepti Cleanse® Non-sterile
32 ounce bottle for Asepti Cleanse® Sterile
AVAILABLE TECHNICAL DATA SUPPLEMENTS
(UPON REQUEST)
DECON-AHOL WFI Product Validation
Technical Data File
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4
4
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12
12
12
1
12
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D E C O N - A H O L® S T E R I L E
FORMULA USP ISOPROPYL ALCOHOL
DECON-AHOL (NON WFI VERSION)
Order#
Order#
DECB-99
DECON-AHOL
DECON-AHOL
DECON-AHOL
DECON-AHOL
Quan/cs.
70%
70%
70%
70%
55
16
32
16
Gallon Non-Sterile
oz. Trigger Non-Sterile
oz. Trigger Non-Sterile
oz. Trigger Sterile
Description
Quan/cs.
DECON-AHOL 99% Gallon Sterile
1
12
12
12
SCMD
DECB-55G-70
DECTR-01
DECTR-07
DECTR-08
Description
4
(UPON REQUEST)
DECON-AHOL VL-101-B Product Validation
Technical Data File
13
S T E R - A H O L® W F I S T E R I L E
DENATURED ETHANOL WITH USP WFI WATER
EPA Registered hard surface disinfectent and sanitizer.
STER-AHOL WFI Sterile Formula is 70% Denatured Ethanol made with USP Water for Injection
SCMD
STER-AHOL WFI Formula is:
• Made with USP Water for Injection
• Formulated to 70% and denatured with a small percentage of Methyl Alcohol and Isopropyl Alcohol
• Available in aerosol spray (nitrogen propellant), 16 ounce containers and 1-gallon containers
• Delivered with lot specific Certificate of Irradiation, Certificate of Analysis, LAL Testing Analysis
and Sterility Report
• Quadruple bagged using the ABCD® Clean Room Introduction System
USES: STER-AHOL WFI Sterile Formula is used for the decontamination of items such as:
• Gloves
• Surfaces
• Carts
• Countertops
• Aseptic connections
• Applications that require a sterile alcohol solution made with USP Water for Injection
DSTER-WFI-TR-04
Order#
Description
DSTER-WFI-SP-70
DSTER-WFI-B-70
DSTER-WFI-TR-04
DSTER-WFI-70-5G
70%
70%
70%
70%
Quan/cs.
11 oz. Aerosol Mist Spray Sterile
1 Gallon Sterile
16 oz. Trigger Spray Sterile
5 Gallon Sterile
24
4
12
1
(UPON REQUEST)
STER-AHOL WFI Product Validation
Technical Data File
14
1-888-4-STERILE
1-888-478-3745
SIMPLEMIX® SYSTEMS
For the Exact Formulation of Disinfectants and Sporicides.
ADVANTAGES AND FEATURES:
•
•
•
•
1 GALLON STERILE
Order#
Description
DP-04-1Z
DCY-04-1/2Z
DQ100-04-2Z
DC-04-1Z
DS200-04-1/2ZA
DS200-04A
DQ200C-04-2Z
DECON-PHENE 1:128 use dilution 1 gal. mixture
DECON-CYCLE 0.5:128 use dilution 1 gal. mixture
DECON-QUAT 100 2:128 use dilution 1 gal. mixture
DECON-Clean 1:128 use dilution 1 gal. mixture
DECON-SPORE 200 Plus 0.5:128 use dilution 1 gal. mixture
DECON-QUAT 200C 1:28 use dilution 1 gal. mixture
1 GALLON NON-STERILE
Order#
Description
DP-05-1Z
DCY-05-1/2Z
DQ100-05-2Z
DC-05-1Z
DS200-05-1/2ZA
DS200-05A
DQ200C-05-2Z
DECON-PHENE 1:128 use dilution 1 gal. mixture
DECON-CYCLE 0.5:128 use dilution 1 gal. mixture
DECON-QUAT 100 2:128 use dilution 1 gal. mixture
DECON-Clean 1:128 use dilution 1 gal. mixture
DECON-QUAT 200C 1:28 use dilution 1 gal. mixture
SCMD
Eliminates concerns by regulatory agencies for proper mixing and sterility of the solution
No filtering solutions to aseptic manufacturing areas
No need to assure sterile USP Water For Injection is present in the aseptic area
No concerns for mixing and handling concentrate phenolics, quaternary ammoniums,
peroxyacetic acid & H202 or cleaners with sterile water in aseptic manufacturing operations
• The system assures the appropriate dilution is made each time in a closed sterile system
• Dilutions are made safely as concentrates are never handled
• All chemical agents and the WFI Quality Water‚ are filtered at 0.2 microns and manufactured
in a clean room filling operation
• The contents of the double bagged package are sterilized through a validated gamma
radiation cycle that assures a 10-6 Sterility Assurance Level
• All product lots are sterility tested per current USP compendium
• Available in 2 sizes – 1 gallon and 16 ounce trigger sprayer
• Simply remove the top cap, push the inner bottle down, replace the cap and shake gently.
The solution is then ready to use
• Available Sterile and Non-Sterile in the following VAI products:
– DECON-PHENE®
– DECON-QUAT 100®
®
– DECON-CYCLE
– DECON-Clean®
– DECON-SPORE® 200 Plus
– DECON-QUAT 200C
Quan/cs.
4
4
4
4
4
4
4
Quan/cs.
4
4
4
4
4
4
4
15
SIMPLEMIX® SYSTEMS
16 OUNCE STERILE
Order#
Description
SCMD
DP-06-16Z-01
DP-06-16Z-02
DCY-06-16Z-01
DCY-06-16Z-02
DQ100-06-16Z-01
DS200-06-16Z-01
DS200-06-16Z-02
DC-06-16Z-01
DQ200C-06-16Z-01
DECON-PHENE
DECON-PHENE
DECON-CYCLE 0.0625 oz./16 oz. of water
DECON-QUAT 100 0.250 oz./16 oz. of water
DECON-SPORE 200 Plus Sterilant 0.8/16 oz. of water
DECON-SPORE 200 Plus Disinfectant 0.0625 oz./16 oz. of water
DECON-Clean 0.125 oz./16 oz. of water
DECON-QUAT 200C 0.125 oz./16 oz. of water
16 OUNCE NON-STERILE
Order#
Description
DP-07-16Z-01
DP-07-16Z-02
DCY-07-16Z-01
DCY-07-16Z-02
DQ100-07-16Z-01
DS200-07-16Z-01
DS200-07-16Z-02
DC-07-16Z-01
DQ200C-07-16Z-01
Quan/cs.
Quan/cs.
DECON-PHENE
12
DECON-PHENE
12
12
12
DECON-QUAT 100 0.250 oz./16 oz. of water
12
DECON-SPORE 200 Plus Sterilant 0.8/16 oz. of water
12
DECON-SPORE 200 Plus Disinfectant 0.0625 oz./16 oz. of water 12
DECON-Clean 0.125 oz./16 oz. of water
12
DECON-QUAT 200C .125 oz./16 oz. of water
12
(UPON REQUEST)
SimpleMix Product Validation
Technical Data File
16
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1-888-478-3745
SIMPLEMIX® 200L
ASEPTIC MIXING SYSTEM
FOR LARGE SCALE ASEPTIC MANUFACTURING ENVIRONMENTS
SCMD
The SimpleMix 200L Aseptic Mixing System provides the ability to mix 200 Liters of
disinfectants and sporicides in a closed system for users whom require larger volumes
of cleaning agents in their operations. The patented SimpleMix 200L Closed Mixing
System incorporates a three integral parts; a 200L container of 0.2 micron filtered
sterile USP Water for Injection (bottom container), a cubicontainer of 0.2 micron filtered
sterile concentrate disinfectant or sporicide (top container) and a patented hose
and valve system. The 200L container and the cubicontainer are connected via the
sterile hosing and valve system awaiting activation by the end user. The entire 200L
system container, cubicontainer and hoses are double bag packaged and shipped to
the end user.
The method of attaining a sterile product by Veltek Associates, Inc. is dependent upon
the concentrate disinfectant/sporicide’s stability in varying sterilization methodologies.
Two methodologies are employed. Products are either aseptically filled in a Grade A,
ISO 5 area utilizing presterilized components (containers, hoses and bags) or packaged in a Grade A, ISO 5 area and subsequently terminally sterilized through a validated 10-6 SAL gamma radiation cycle. The SimpleMix 200L Aseptic Mixing System (WFI
water and disinfectant/sporicide) are subsequently tested per lot for sterility via current
USP protocol in either manufacturing methodology.
DECON-PHENE, DECON-CYCLE, DECON-Clean and DECON-QUAT 100 are
processed sterile via filtering and packaging that is done in a Grade A, ISO 5 area and
subsequently terminally sterilized through a validated 10-6 SAL cycle.
DECON-SPORE 200 Plus and HYPO-CHLOR are aseptically processed.
* HYPO-CHLOR is provided RTU in formulations of 0.25% & 0.52% and is simply
pumped directly from the 200L container.
As received by the end user, the entire 200L container is double bag packed and
skidded. An end user can transfer the container via dolly, manual or automated
lifting/transporting device to the Grade C, ISO 8 area where one outer bag is removed.
The 200L containers is then transfer to the Grade B, ISO 7 area where the second
outer bag is removed prior to entry to the Grade A, ISO 5 area. At this point, one hose
is inserted into the peristaltic pump. The pump can technically be located in any grade
Step 1
Step 2
Step 3
17
SCMD
as the SimpleMix 200L is a closed system of mixing. The container can be mixed in
lower classifications and pumped to the desired end use point or mixed within the
higher classification areas as all inside the double bag has been rendered sterile.
The peristaltic pump mixes the cubicontainer containing the concentrate with the
Water for Injection for approximately 3-5 minutes. The solution is contained in a
closed sterile disposable system. By opening of the dispense valve the sterile
solution can be distributed through the sterile closed system to point of use. Once
the end valve is closed, the system ensures its sterile integrity for the next use.
The SimpleMix 200L Closed Mixing System is another innovative solution from
Veltek Associates, Inc. to assist large scale manufacturing operations with the
difficult task of getting sterile disinfectants and sporicides to the aseptic area.
Order#
DC-10-200L-Cl
DCY-10-200L-Cl
DQ100-10-200L-2Xl
DQ200C-10-200L-2XI
DS200-10-200L-SD-Cl
Description
Quan/cs.
DECON-Clean SimpleMix 200L cubicontainer Sterile
DECON-CYCLE SimpleMix® 200L cubicontainer-Sterile
DECON-QUAT® 100 SimpleMix® 200L cubicontainer Sterile
DECON-QUAT 200C Simple Mix 200L cubicontainer
DECON-SPORE® 200 Plus SimpleMix® 200L cubicontainer
Sporicidal Dose Sterile
DS200-11-200L-SD-Cl DECON-SPORE® 200 Plus SimpleMix® 200L cubicontainer
Disinfectant Dose Sterile
DP-10-200L-Cl
DECON-PHENE® SimpleMix® 200L cubicontainer Sterile
Step 4
18
®
Step 5
®
1
1
1
1
1
1
Step 6
1-888-4-STERILE
Step 7
1-888-478-3745
DECON-HAND®
INSTANT HAND SANITIZER
DECON-HAND is a gelled alcohol hand sanitizer for hand sanitizing to
decrease bacteria on the skin.
DECON-HAND:
SCMD
• Is used by applying thoroughly to the hands and allowed to dry without wiping
(use no water or towels)
• Is Double-bagged packaged
• Is Gamma irradiated
• Manufactured in accordance with 21 CFR Part 211 Good Manufacturing Practices for
DRUGS and the Tentative Final Monograph for Topical Antimicrobial Drug Products for
Over-the-Counter use
• Can be used with the DH-100 dispenser/holder system or the Asepti-Cleanse hands-free
dispenser
• Is completely tested according to current USP compendium
• Is delivered with lot specific sterile documentation
• Is completely validated for sterility and shelf life
• Available in the Quadruple bagged ABCD Clean Room Introduction System®
USES: DECON-HAND is used as an instant hand sanitizer before glove doning.
Order#
Description
DH-04
DH-06
DH-09
DECON-HAND 16 oz. Non-sterile
DECON-HAND 16 oz. Sterile
DECON-HAND Non-Sterile 32 oz. Bottle
for Asepti-Cleanse
DECON-HAND Sterile 32 oz. Bottle for Asepti-Cleanse
DECON-HAND Wall Dispenser (316L Stainless)
Push Pump for 16 oz. DECON-HAND Bottle
DH-10
DH-100
216-P
Quan/cs.
12
12
12
DH-06
12
1
1
(UPON REQUEST)
DECON-HAND Product Validation
Technical Data File
DH-100
19
ASEPTI-CLEANSE®
HANDS-FREE DECON-AHOL® WFI/DECON-HAND® DISPENSER
ASEPTI-CLEANSE dispenser is a hands-free dispenser for DECON-AHOL WFI and DECONHAND. The system has been designed by VAI as the most advanced infrared sensor
dispensing system available in the pharmaceutical and biotechnology industries. The
dispensing unit is designed to meet the requirements of cGMP clean room operations.
SCMD
ASEPTI-CLEANSE Dispensing System:
DEC-301
• Is a sealed unit that protects the coated internal electronics
• Is photo-eye operated. Just place your hand underneath and it dispenses a pre-measured
dose to the hand without contact of the person to the unit
• Can be adjusted to dispense 1, 3 or 5 mL
• Is designed in a dual power configuration of power supply. It can be powered by 4 D Cell
batteries (4 D Cells last over 1 year) or connected to a 220 Volt receptacle. In the electrically
mounted installation, one has the backup of the battery power if a failure in the power
line occurs due to an abnormal situation
• Mounts directly on glass or walls
• Is water resistant in design
• Is small. It measures 12 inch long x 5 inches wide x 2 inches high and has a keyless
opening and closing system
Order#
Description
Quan/cs.
DEC-301
ASEPTI-CLEANSE Dispenser for 32 oz. Bottles
Operates on 4 D-Cell Batteries or 110V direct connections
1
Refills for Asepti-Cleanse Dispensers
Order#
Description
DECWFI-BOT-01
DECON-AHOL WFI Non-Sterile 70% IPA Bottles,
32 oz. fill double bag packaged, for Asepti-Cleanse
DECON-AHOL WFI Sterile 70% IPA Bottles,
32 oz. fill double bag packaged, for Asepti-Cleanse
DECON-HAND Non-Sterile 32 oz. Bottle
for Asepti-Cleanse
DECON-HAND Sterile 32 oz. Bottle for Asepti-Cleanse
DECON-SOAP 32 oz. Bottle for Asepti-Cleanse
DECON-SOAP 32 oz. Bottle for Asepti-Cleanse
DECWFI-BOT-02
DH-10
DH-09
DH-10
DSOAP-BOT-01
DSOAP-BOT-02
Quan/cs.
1-888-4-STERILE
12
12
12
12
12
(UPON REQUEST)
Technical Data File
20
12
1-888-478-3745
ALCOHOL DISPENSERS
FOR USE WITH VAI ALCOHOL PRODUCTS
Several options exist to further simplify the dispensing of our DECON-AHOL WFI® and
STER-AHOL WFI® products. The hand activated and hands-free dispensing mechanisms
(DEC-501 and DEC-100) assure the elimination of cross contamination from user to user during handling of the alcohol container. The bulk container mechanisms (200-P and 300-T) simplify dispensing of the product while delivering dosed quantities to prevent overuse of the
product.
SCMD
DEC-501 Hand-Activated Dispenser:
• Easy back of hand dispensing
• 316L Stainless Steel construction
• Dispensing mechanism easily slides on and off a permanently installed wall plate that
incorporates welded pin connectors
• Autoclavable
200-P Gallon Pump Dispenser:
•
•
•
•
Attaches to DECON-AHOL WFI and STER-AHOL WFI 1 gallon containers
Top lever dispenses a specified dose of alcohol (1 ounce)
Double bagged packaged
Gamma irradiated
DEC-501
300-T Gallon Trigger Sprayer:
• Attaches to DECON-AHOL WFI and STER-AHOL WFI 1 gallon containers
• Trigger sprayer dispenses a specified dose of alcohol (1.3 cc)
• Incorporates an extended hose from the top of the 1 gallon container to the trigger sprayer
for hard to reach areas
• Double bagged packaged
Order#
Description
DEC-501
200-P
300-T
320-PT
321-T-S
Hands-Free Back of Hand Activated Dispenser
1 Gallon Pump Spray Dispenser Sterile
1 Gallon Trigger Spray Dispenser Sterile
Pour top for 32 oz. Bottle
Trigger Spray for 32 oz. Bottle
Quan/cs.
1
4
4
4
4
200-P
(UPON REQUEST)
Technical Data File
300-T
21
D E C O N - P H E N E®
STERILE PHARMACEUTICAL CLEAN ROOM FORMULA
DECON-PHENE is a high pH, sodium based, phosphate free phenolic synthetic germicidal
detergent that is used where a broad spectrum disinfectant is required in moderate amounts
of organic soil.
DECON-PHENE is:
SCMD
•
•
•
•
•
•
•
•
DP-03-4Z
•
•
•
•
Filtered at 0.2 Microns
Double-bagged packaged
Gamma irradiated
Strong enough to kill a broad spectrum of pathogenic and non-pathogenic bacteria
Mild enough to have no harmful effect on the surface being disinfected
Detergent that has efficacy performance that confirms to AOAC protocol testing at a use
dilution of 1:128 in the presence of 5% blood serum at 20 degrees Celsius with an exposure
time of 10 minutes
Completely tested for sterility according to current USP compendium
Delivered with lot specific Certificate of Analysis, and Sterility Report, Certificate of
Irradiation
Completely traceable
Completely validated for sterility and shelf life
Validated for a 2 year expiration on unopened product
Available in the Quadruple bagged ABCD Clean Room Introduction System®
USES: DECON-PHENE is used for the decontamination of:
• Walls
• Ceilings
• Floors
DP-02
Order#
Description
DP-01
DP-02
DP-03-4Z
DP-03-2Z
DP-04-1Z
DP-04-2Z
DP-05-1Z
DP-06-16Z-01
DP-06-16Z-02
DP-07-16Z-01
DP-07-16Z-02
DP-10-200-L-CI
DECON-PHENE Gallon Non-Sterile
DECON-PHENE Gallon Sterile
DECON-PHENE 4 oz. Sterile
DECON-PHENE 2 oz. Sterile
DECON-PHENE 1:128 use dilution SimpleMix® Sterile
DECON-PHENE 1:64 2x dilution SimpleMix® Sterile
DECON-PHENE 1:128 use dilution SimpleMix® NonSterile
DECON-PHENE SimpleMix® Sterile
DECON-PHENE SimpleMix® Sterile
DECON-PHENE SimpleMix® NonSterile
DECON-PHENE SimpleMix® NonSterile
DECON-PHENE SimpleMix® 200L Cubicontainer
Quan/cs.
(UPON REQUEST)
DECON-PHENE Product Validation
Technical Data File
22
1-888-4-STERILE
1-888-478-3745
4
4
24
24
4
4
4
12
12
12
12
1
DECON-PHASE®
DECON-PHASE is a potassium-based phenolic germicidal solution.
DECON-PHASE is:
SCMD
• Used where a broad spectrum of disinfection is required in moderate amounts of organic soil
• Strong enough to kill a broad spectrum of pathogenic and non-pathogenic bacteria
• Mild enough to have no harmful effect on the surface being disinfected
• A phosphate free germicidal detergent that has efficacy performance which has been
confirmed using AOAC protocol testing at a use dilution of 1:256 in the presence of 5%
blood serum at 20 degrees Celsius with an exposure time of 10 minutes
• Completely tested for sterility according to current USP compendium
• Delivered with lot specific Certificate of Analysis and Sterility Report, Certificate of
Irradiation
• Validated for a 2 year expiration on unopened product
DEP-03-2Z
USES: DECON-PHASE is used for the decontamination of:
• Walls
• Ceilings
• Floors
Order#
Description
DPH-01
DPH-02
DPH-03-2Z
DPH-04-1/2Z
DPH-05-1/2Z
DPH-06-16Z-01
DPH-07-16Z-02
DECON-PHASE
DECON-PHASE
DECON-PHASE
DECON-PHASE
DECON-PHASE
DECON-PHASE
DECON-PHASE
Quan/cs.
Gallons Non-Sterile
4
Gallons Sterile
4
2 oz. Sterile
24
0.5/128 use dilution SimpleMix® Sterile
4
0.5/128 use dilution SimpleMix® Non-Sterile
4
0.0625 oz./16 oz. WFI water SimpleMix® Sterile 12
0.0625 oz./16 oz. WFI water SimpleMix® Non-Sterile 12
DPH-02
(UPON REQUEST)
DECON-PHASE Product Validation
Technical Data File
23
DECON-CYCLE®
DECON-CYCLE is a phosphate free, low pH germicidal detergent.
SCMD
DECON-CYCLE is:
DCY-03-2Z
• A low pH phenolic, dilutable, hospital detergent effective in 10 minutes at 20 degrees Celsius
in hard water up to 400 ppm (calculated as CaCO3) in the presence of 5% blood serum.
• Recommended for use in pharmaceutical, biotechnology, medical device manufacturing,
hospitals and any health care institutions that are dedicated to controlling the hazards of
cross contamination
• A multi-phenolic formula designed to clean, disinfect, and deodorize any washable inanimate
surface
• Strong enough to kill a broad spectrum of pathogenic bacteria
• Mild enough to have no harmful effect on the surface being disinfected
• Delivered with lot specific Certificate of Analysis and Sterility Report, Certificate of
Irradiation
•Available in the Quadruple bagged ABCD Clean Room Introduction System®
USES: DECON-CYCLE is used as a disinfectant on:
• Hard, inanimate surfaces
• Floors
in filling and gowning rooms
• Walls
• General manufacturing areas
• Stainless steel
• Machinery tables
• Porcelain
• Countertops
• Glass
• Laminar flow benches
• Chrome
DCY-02
Order#
Description
DCY-01
DCY-02
DCY-03-1Z
DCY-03-2Z
DCY-04-1/2Z
DCY-05-1/2Z
DCY-04-1Z
DCY-06-16Z-01
DCY-06-16Z-02
DCY-07-16Z-01
DCY-07-16Z-02
DCY-10-200L-CI
DECON-CYCLE 1 Gallon Non-Sterile
4
DECON-CYCLE 1 Gallon Sterile
4
DECON-CYCLE 1 oz. Sterile
24
DECON-CYCLE 2 oz. Sterile
24
DECON-CYCLE 0.5/128 use dilution SimpleMix® Sterile
4
DECON-CYCLE 0.5/128 use dilution SimpleMix® Non-Sterile
4
DECON-CYCLE 1:128 2x dilution SimpleMix® Sterile
4
DECON-CYCLE 0.0625 oz./16 oz. WFI water SimpleMix® Sterile 12
DECON-CYCLE 0.125 oz./16 oz. WFI water SimpleMix® Sterile 12
DECON-CYCLE 0.0625 oz./16 oz. WFI water SimpleMix® Non-Sterile 12
DECON-CYCLE 0.125 oz./16 oz. WFI water SimpleMix® Non-Sterile 12
DECON-CYCLE SimpleMix® 200L Cubicontainer
1
Quan/cs.
(UPON REQUEST)
DECON-CYCLE Product Validation
Technical Data File
24
1-888-4-STERILE
1-888-478-3745
DECON-CLEAN®
STERILE CLEAN ROOM FORMULA
DECON-Clean is a cleaning agent designed to remove residues from disinfecting agents.
DECON-CLEAN is:
USES: DECON-CLEAN is used for:
• Walls
• Countertops
• Ceilings
• Process lines
• Floors
• Aseptic connections
• Stainless items
DC-03-4Z
Order#
Description
DC-01
DC-02
DC-03-4Z
DCWFI-SP-11Z
DC-04-1Z
DC-05-1Z
DC- 06 -16Z - 01
DC-07-16Z - 01
DC-10-200L-CI
DECON-Clean Gallons Non-Sterile
DECON-Clean Gallons Sterile
DECON-Clean 4 oz. Sterile
DECON-Clean 11 oz Aerosol, Sterile
DECON-Clean 1/128 use dilution SimpleMix® Sterile
DECON-Clean 1/128 use dilution SimpleMix® Non-Sterile
DECON-Clean 0.125 oz./16 oz. use dilution SimpleMix® Sterile
DECON-Clean 0.125 oz./16 oz. use dilution SimpleMix® Non-Sterile
DECON-CLEAN SimpleMix® 200L Cubicontainer
SCMD
• Filtered to remove particulates and bioburden prior to gamma irradiation
• One-step residue remover when diluted to 1:128 (1 ounce/1 gallon) of hard or soft water
(400 ppm hard as CaCO3)
• Designed for washable, non-porous environmental surfaces
• Delivered with lot specific Certificate of Analysis and Sterility Report
Quan/cs.
4
4
24
24
4
4
12
12
1
DC-02
(UPON REQUEST)
DECON-Clean Product Validation
Technical Data File
25
H Y P O - C H L O R® W F I F O R M U L A
HYPO-CHLOR is a sterile sodium Hypochlorite solution.
HYPO-CHLOR is:
SCMD
• Aseptically filled into presterilized components (sterilized via gamma irradiation)
• Ready-to-use
• Available in premixed concentrations of 5.25%, 0.52% and 0.25%
• Formulated with USP WFI
• Validated for an 18 month expiration on unopened product
SHC-16Z-0.52
USES: HYPO-CHLOR is used for:
• Walls
• Ceilings
• Floors
• Surfaces
Order#
Description
SHC-01-5.25
SHC-02-5.25
SHC-02-0.52
SHC-02-0.25
SHC-16Z-5.25
SHC-16Z-0.52
SHC-16Z-0.25
SHC-13Z-5.25
SHC-10-200L-0.25
SHC-10-200L-0.52
SHC-32Z-0.52
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
HYPO-CHLOR
Quan/cs.
Gallons Non-Sterile @ 5.25%
Gallons Sterile @ 5.25%
16 oz. Trigger Spray, Sterile @ 5.25%
16 oz. Sterile @ 0.52%
16 oz. Trigger Spray, Sterile @ 0.25%
13 oz. Sterile @ 5.25%
0.25% SimpleMix® 200L Cubicontainer
0.52% SimpleMix® 200L Cubicontainer
0.52% 32 oz. Trigger Spray Sterile
(UPON REQUEST)
HYPO-CHLOR Product Validation
Technical Data File
26
1-888-4-STERILE
4
4
4
4
12
12
12
12
1
1
12
1-888-478-3745
S T E R I - P E R O X® W F I F O R M U L A
STERI-PEROX is a sterile hydrogen peroxide solution.
STERI-PEROX is:
USES: STERI-PEROX is used for:
• Walls
• Ceilings
• Floors
• Surfaces
Order#
Description
SPER-01-3%
SPER-01-6%
SPER-02-3%
SPER-02-6%
SPER-16Z-3%
SPER-16Z-6%
SPER-WFI-55-3%
STERI-PEROX
STERI-PEROX
STERI-PEROX
STERI-PEROX
STERI-PEROX
STERI-PEROX
STERI-PEROX
SCMD
• Aseptically filled into presterilized components (sterilized via gamma irradiation)
• Available in two premixed concentrations – 3% and 6%
• Ready-to-use
SPER-16Z-3%
Quan/cs.
Gallons Non-Sterile@3%
Gallons Non-Sterile@6%
Gallons Sterile@3%
Gallons Sterile@6%
16 oz. Trigger Spray, Sterile@3%
16 oz. Trigger Spray, Sterile@6%
55 Gallon, Sterile@3%
4
4
4
4
12
12
1
SPER-02-6%
(UPON REQUEST)
STERI-PEROX Product Validation
Technical Data File
27
D E C O N - Q U A T® 1 0 0
QUATERNARY AMMONIUM SOLUTION
DECON-QUAT 100‚ is a quaternary ammonium solution for use in hospital/medical and health
care institutions.
SCMD
DECON-QUAT 100 is:
DQ100-03-8Z
• Effective as a broad spectrum hospital disinfectant, deodorizer, hard surface disinfectant,
food and non-food contact surface sanitizer. May be used in USDA inspected facilities
• Effective against Pseudomonas aeruginosa, Staphylococcus aureus and Salmonella
choleraesuis
• Effective against Hepatitis B Virus (HBV) when contact time is 10 minutes at 1 ounce/1 gallon
of water*
• A product that also kills Human Immunodeficiency Virus Type 1 (HIV) after 30 seconds
contact time*
•Available in the Quadruple bagged ABCD Clean Room Introduction System®
USES: DECON-QUAT 100 is used as a disinfectant on inanimate, hard, non-porous
environmental surfaces such as:
• Walls
• Ceilings
• Floors
• Countertops
*SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATING AGAINST HIV-1 AND HBV OR
SURFACES/OBJECTS SOILED WITH BLOOD/BODY FLUIDS
DQ100-04-2Z
Order#
Description
DQ100-01
DQ100-02
DQ100-03-2Z
DQ100-03-8Z
DQ100-04-2Z
DQ100-05-2Z
DQ100-06-16Z-01
DQ100-07-16Z-01
DECON-QUAT
DECON-QUAT
DECON-QUAT
DECON-QUAT
DECON-QUAT
DECON-QUAT
DECON-QUAT
DECON-QUAT
Non-Sterile
DQ100-10-200L-2XI DECON-QUAT
Quan/cs.
100
100
100
100
100
100
100
100
-
1 Gallon Concentrate Non-Sterile
4
1 Gallon Concentrate Sterile
4
2 oz. Concentrate Sterile
24
8 oz. Concentrate Sterile
24
2/128 use dilution SimpleMix® Sterile
4
2/128 use dilution SimpleMix® Non-Sterile
4
0.250 oz./16 oz. WFI water SimpleMix® Sterile 12
0.250 oz./16 oz. WFI water SimpleMix®
12
100 SimpleMix® 200L Cubicontainer
1
(UPON REQUEST)
DECON-QUAT Product Validation
Technical Data File
28
1-888-4-STERILE
1-888-478-3745
D E C O N - Q U A T® 2 0 0 C
DECON-QUAT 200C (CONCENTRATE)
DECON-QUAT 200C is a fifth generation quaternary ammonium solution for use in hospital/medical
and healthcare institutions. Effective as a broad spectrum hospital disinfectant, fungicide,
deodorizer, hard surface disinfectant, non-food contact sanitizer effective against a broad spectrum
of bacteria and viruses.
DECON-QUAT 200C is:
•
•
•
•
•
•
Filtered at .2 micron
Double-bagged packaged
Gamma Irradiated
Effective as a broad spectrum disinfectant, non-food contact sanitizer, cleaner, mildewstat,
fungicide, virucide, deodorizer.
Effective against pseudomonas aeruginosa, staphylococcus aureus, Salmonella (enteric or
typhimurium) (choleraesuis is not in masons master label)
Effective against Effective against Hepatitis B Virus (HBV), Human Immunodeficiency
Virus type 1 (HIV 1) and Influenza A (H1N1) when contact time is 10 minutes at
2 ounce/ I gallon.
Delivered with lot specific Certificate of Analysis, Certificate of Irradiation and Sterility
Report.
Completely Traceable
Completely validated for sterility and self life
SCMD
•
•
•
•
USES: DECON-QUAT 200C is used as a disinfectant on inanimate, hard, non-porous,
environmental surfaces such as:
• Walls
• Ceilings
• Floors
• Countertops
Order#
Description
DQ200C-01
DQ200C-02
DQ200C-03-2Z
DQ200C-03-8Z
DQ200C-04-2Z
DQ200C-05-2Z
DQ200C-06-16Z-01
DQ200C-07-16Z-01
DQ200C-01 - 1 Gallon Concentrate Non-Sterile
DQ200C-02 - 1 Gallon Concentrate Sterile
DQ200C-03-2Z - 2 oz. Concentrate Sterile
DQ200C-03-8Z - 8 oz. Concentrate Sterile
DQ200C-04-2Z 2/128 use dilution SimpleMix® Sterile
DQ200C-05-2Z 2/128 use dilution SimpleMix® Non-Sterile
DQ200C-06-16Z-01 0.250 oz./16 oz. WFI water SimpleMix® Sterile
DQ200C-07-16Z-01 0.250 oz./16 oz. WFI water SimpleMix® Non-Sterile
Quan/cs.
4
4
24
24
4
4
12
12
29
D E C O N - S P O R E® 2 0 0 P L U S
DECON-SPORE 200 Plus is a peracetic acid and hydrogen peroxide solution that can be used
as either a steriliant or disinfectant.
SCMD
DECON-SPORE 200 Plus is:
DS200-03-2ZA
• Aseptically filled into pre-sterilized components (sterilized via gamma irradiation)
• Designed for the sterilization of manufacturing, packaging and filling equipment in aseptic
processes.
• Confirmed by AOAC protocol testing at a dilution of 5% (6.4 ounces/128 ounces) in hard or
soft water (500 ppm as CaCO3) for sterilization
– Suggested to be exposed to the surface for a minimum exposure time based on the
temperature of the solution:
• 68 degrees, 6 hours
• 122 degrees, 20 minutes
• 176 degrees, 5 minutes
• Confirmed by AOAC protocol testing at a dilution of 0.4% (0.394 ounces/1 gallon) in hard or
soft water for disinfection and Turbewicidal
– Suggested to be exposed to the surface for 10 minutes at 20 degrees Celsius in the
presence of 5% blood serum and soap film on a non-porous surface
• Validated for 1 year expiration on unopened product
USES: DECON-SPORE 200 Plus is used for:
• Walls • Ceilings • Floors • Surfaces
Order#
DS200-03-13ZA
DS200-02A
Description
Quan/cs.
DS200-01A
DS200-02A
DS200-03-1ZA
DS200-03-2ZA
DS200-03-13ZA
DS200-04-1/2ZA
DS200-04A
DS200-05-1/2ZA
DS200-05A
DS200-06-16Z-01
DS200-06-16Z-02
DS200-07-16Z-01
DS200-07-16Z-02
DS200-10-200L-SD-CI
DECON-SPORE 200Plus 1-Gallon Non-Sterile
DECON-SPORE 200Plus 1-Gallon Sterile
DECON-SPORE 200Plus 0.8oz. Sterile (Unit Dose sterilant w/16 oz. of water)
DECON-SPORE 200Plus 2oz. Sterile (Unit Dose disinfectant w/4 gal of water)
DECON-SPORE 200Plus 13oz. Sterile (Unit Dose sterilant w/2 gal of water)
DECON-SPORE 200Plus 0.5/128 use dilution SimpleMix® Sterile
DECON-SPORE 200Plus 6.4/128 use dilution SimpleMix® Sterile
DECON-SPORE 200Plus 0.5/128 use dilution SimpleMix® Non-Sterile
DECON-SPORE 200Plus 6.4/128 use dilution SimpleMix® Non-Sterile
DECON-SPORE 200Plus 0.8 oz./16 oz. WFI water SimpleMix® Sterile
DECON-SPORE 200Plus 0.0625 oz./16 oz. WFI water SimpleMix® Sterile
DECON-SPORE 200Plus 0.8 oz./16 oz. WFI water SimpleMix® Non-Sterile
DECON-SPORE 200Plus 0.0625 oz./16 oz. WFI water SimpleMix® Non-Sterile
DECON-SPORE 200 Plus SimpleMix® 200L Sporicial Dose Cubicontainer
Sterile
DS200-11-200L-SD-CI DECON-SPORE 200 Plus SimpleMix® 200L Disinfectant Dose
Cubicontainer Sterile
(UPON REQUEST)
DECON-SPORE 200 Plus Product Validation
Technical Data File
30
1-888-4-STERILE
1-888-478-3745
4
4
24
24
12
4
4
4
4
12
12
12
12
1
1
S T E R I - W A T E R®
STERI-WATER is a sterile USP Purified Water.
USES: STERI-WATER is used where the availability of a quality water grade is necessary in:
• Chemical formulation
• Cleaning
• Rinsing
Order#
Description
STWA-01
STWA-02
STWA-16Z
STWA-2G
STWA-5G
STERI-WATER
STERI-WATER
STERI-WATER
STERI-WATER
STERI-WATER
STWA-16Z
Quan/cs.
Gallons Non-Sterile
Gallons Sterile
16 oz. Sterile
2 Gallons Sterile
5 Gallons Sterile
SCMD
• Ready-to-use
• Delivered with lot specific Certificate of Analysis and Sterility Report and Certificate of
Irradiation
• Validated for 2 year expiration on unopened product
4
4
12
2
1
(UPON REQUEST)
STERI-WATER Product Validation
Technical Data File
STWA-02
31
V A I W F I Q U A L I T Y W A T E R®
FOR STERILE DISINFECTANT DILUTIONS
IN CLEAN ROOM OPERATIONS
VAI WFI QUALITY WATER is a high quality water produced from our validated WFI water system.
VAI WFI QUALITY WATER is:
SCMD
• Manufactured in a GMP, ISO 5, Grade A area
• An excellent choice for dilution of disinfectant concentrates to a use-dilution mixture
• Tested for assay, sterility and endotoxin levels
• Delivered with lot specific Certificate of Analysis and Sterility Report and Certificate of Irradiation
VAI-WFI-16Z
USES: VAI WFI QUALITY WATER is:
• For disinfectant preparation and dilution
• NOT FOR PARENTERAL ADMINISTRATION
Order#
VAIWFI-16Z
VAIWFI-1G
VAIWFI-2G
VAI-WFI-200L
VAI-WFI-200L-2B
VAI-WFI-SP-11Z
VAI-WFI-1G
Description
VAI
VAI
VAI
VAI
VAI
VAI
WFI
WFI
WFI
WFI
WFI
WFI
Quality
Quality
Quality
Quality
Quality
Quality
Quan/cs.
Water
Water
Water
Water
Water
Water
16 oz. Trigger Spray Container Sterile
1 Gallon Container Sterile
2 Gallon Container Sterile
200L Sterile Single bag
200L Double-bagged, Sterile
11 oz Aerosol Sterile
(UPON REQUEST)
Technical Data File
32
1-888-4-STERILE
1-888-478-3745
12
4
2
1
1
24
S T E R I - B U F F E R® 9 0 & 9 9
STERILE PHOSPHATE BUFFER
PH 7.2MADE WITH USP WATER FOR INJECTION
STERI-BUFFER‚ 90 & 99 are a sterile phosphate buffered to a pH of 7.2 + 0.2.
STERI-BUFFER is:
USES:
• Filter rinsing
• Steritest buffers
SCMD
• Filled in easy-open and close wide-mouth bottles
• Filtered at 0.2 microns
• Terminally sterilized through a validated cycle at a SAL level of 10-6 to assure sterility
• Lot sterility tested per current USP compendium
• Delivered with a Certificate of Analysis, Certificate of Sterility and Certificate of Irradiation
• Sealed with a “no-tamper” strip that is broken once the bottle is opened
• Validated for sterility and shelf life of 2 years
• Filled in bottles that are scaled on 4 sides for easy measurement
• Validated for a 2 year expiration unopened product
SB-100-90
Order#
Description
SB100-90
SB100-99
STERI-BUFFER 90 - 90 mL Sodium Phosphate Buffer
STERI-BUFFER 99 - 99 mL Sodium Phosphate Buffer
Quan/cs.
72
72
(UPON REQUEST)
Steri-Buffer Product Validation
Technical Data File
SB100-99
33
S T E R I - O I L® 2 0 0
STERI-OIL is a sterile mineral oil lubricant for use in the aseptic manufacturing area.
STERI-OIL is:
SCMD
• A sterile USP grade mineral oil lubricant
• Heavy in consistency providing lubrication and preventing metal to metal contact
• Able to withstand high friction without displacement
• Able to reduce metal fatigue
• Delivered with lot specific Certificate of Analysis, and Sterility Report and Certificate of Irradiation
SO-200-A1Z
USES: STERI-OIL:
• Reduces items from sticking
• Penetrates
• Lubricates mechanisms
• Used for moisture displacement
Order#
Description
SO-200-A1Z
STERI-OIL 200 1 oz. Dropper Sterile
Quan/cs.
250
(UPON REQUEST)
Steri-Oil Product Validation
Technical Data File
34
1-888-4-STERILE
1-888-478-3745
S T E R I - S I L I C O N®
STERI-SILICON is a sterile lubricant and releasing spray.
STERI-SILICON is:
USES: STERI-SILICON is used to speed the process of heat sealing, packaging and
process machinery.
Order#
Description
SSIL-02
STERI-SILICON, 8 oz. Aerosol Spray Sterile
SCMD
• Colorless
• Inert
• Temperature stable
SSIL-02
Quan/cs.
24
(UPON REQUEST)
Steri-Silicon Product Validation
Technical Data File
35
S T E E L - B R I G H T®
CLEAN ROOM FORMULA
STEEL-BRIGHT sterile stainless steel cleaner for use within the aseptic manufacturing area.
STEEL-BRIGHT is:
SCMD
• Used for removal of chemical residues, spotting and staining on stainless steel surfaces without
leaving a powdery residue
• Emulsion based cleaner that will not rainbow or accumulate to a heavy build up
• Delivered with lot specific Certificate of Analysis and Sterility Report, Certificate of Irradiation
SB-02
USES: STEEL-BRIGHT is used for the cleaning of:
• Stainless steel
• Chrome
• Brass
• Aluminum
• Copper
Order#
Description
SB-02
STEEL-BRIGHT 8oz. Aerosol Spray Sterile
Quan/cs.
24
(UPON REQUEST)
Steel Bright Product Validation
Technical Data File
36
1-888-4-STERILE
1-888-478-3745
DECON-GLASS®
DECON-GLASS is designed for pharmaceutical and biotechnology operations that demand a
sterile glass and plexiglass cleaner capable of the removal of residues from disinfecting agents.
DECON-GLASS is:
SCMD
• Ready-to-use residue remover for glass and plexiglass
• Designed for all washable environmental surfaces
• Removes noticeable and unnoticeable residues, smudges, oils and dirt buildup
• Available in 16 ounce trigger spray and 11 ounce aerosol containers
DG-03-16Z
USES: DECON-GLASS is used for the cleaning of:
• Glass
• Plexiglass
• Surfaces
Order#
Description
DG-03-16Z
DG-11Z-SP
DG-02-1G
DECON-GLASS, Trigger Spray, Sterile 16 oz.
DECON-GLASS, Aerosol, Sterile 11 oz.
DECON-GLASS, Gallon, Sterile
Quan/cs.
12
12
4
(UPON REQUEST)
DECON-Glass Product Validation
Technical Data File
37
DECON-SOAP®
DECON-SOAP‚ is a gentle formulation that cleans and moisturizes hands.
DECON-SOAP:
SCMD
•
•
•
•
•
•
Is an antibacterial formula designed to protect against cross-contamination
Contains Triclosan that kills bacteria on contact
Effectively removes dirt from hands
Validated for a 3 year expiration on unopened product
Available in the Quadruple bagged ABCD Clean Room Introduction System®
USES: DECON-SOAP is an effective killing agent for:
• Staphylococcus aureus
• Methicillin resistant staphylococcus aureus (MRSA)
• Staphylococcus epidermidis
• Streptococcus pyogenes
Order#
Description
DSOAP-BOT-01
DECON-SOAP,
Asepti-Cleanse®
DECON-SOAP,
Asepti-Cleanse®
DSOAP-BOT-02
Quan/cs.
32 oz. bottle for
unit Non-Sterile
32 oz. bottle for
unit Sterile
12
12
(UPON REQUEST)
Technical Data File
38
1-888-4-STERILE
1-888-478-3745
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WIPES
W E L C O M E T O VA I W I P E S
V
AI’s Sterile Cleanroom Wipers use innovative manufacturing technologies yielding superior quality exceeds
the requirements of the end user. The single source dedicated supply chain allows the vertical manufacturing
process to be completely traceable from start to finish.
VAI’s wipes are knitted with continuous monofilament polyester made in the USA. The knitting process is completed on state of the art equipment completely dedicated to the finished product. The “focused edge” cutting technology eliminates the risk of particulates being introduced into classified areas by improving the edge over traditional
laser cutting. The knitting process is complete in a class 100,000 (Grade C, ISO 8) manufacturing area located in
North America.
The material is pre-cleaned and de-linted prior to Class 10 Cleanroom Laundry process which uses specially
designed laundy equipment and a UPW (Ultra Pure Water) System. The wipes are dried with class 1 ULPA air. All
materials are quality assurance tested and released to specifications defined per product via ASTM methods. The
wipes are packaged into bags suitable for a class 10 area and labeled with raw material lot number and expiration.
These steps are all completed in a class 10 clean area.
The water system utilizes the latest technology to utilize the water over 4 times in the process, while some of the recycle goes back into the raw water system to be re purified, the Grieg Water is used in waste removal, facility cleaning,
cooling system and irrigation. Less than 15% of the total water used actually goes down the drain.
VAI’s wipes are made with one material dry or saturated for easy inexpensive Validation and consistency throughout
your manufacturing areas. VAI certifies that our wipes meet the specifications upon receipt. All versions of dry or saturated wipes are manufactured under cGMP’s, completely lot traceable and validated.
VAI’s high quality wipes are available in WipeDown® dry wipes, Procees2Wipe® 70% USP IPA and WFI, Hypo-Chlor®
WFI formula in 0.25% and 0.52%, Steri-Perox® WFI formula 3% and 6%, DECON-Clean® RTU residue remover,
individually packaged Alcoh Wipes®, STEEL-BRIGHT® Wipes and DAS® Wipes.
These products are described in detail on the following pages.
WIPEDOWN®
L A U N D E R E D P O LY E S T E R D R Y W I P E
STERILE AND NON-STERILE
WipeDown 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.
WipeDown:
Order#
Description
VEL8-12x12-S-3002
VEL8-12x12-3001
WIPEDOWN Sterile
WIPEDOWN Non-Sterile
WIPES
• Laundered polyester dry wipe
• Class 10 cleanliness
•100% continuous fiber
• Dried in a ULPA filtered class 1 air stream
• Extremely low particulate shedding & soluble extracts
• Available in the Quadruple bagged using the ABCD® Clean Room Introduction System
• Dried with ULPA filtered class 1 air stream
• Laundered with DI water
• Focus edge cutting technology
•12x12 size
• 20 wipes/pack folded for easy removal
• Re-sealable package
VEL8-12X12-S-3002
Quan/cs.
600
600
(UPON REQUEST)
WipeDown Product Validation
Technical Data File
41
P R O C E S S 2 W I P E ® I PA 7 0
GAMMA IRRADIATED TO 10-6 SAL USP 70% IPA in Water for Injection
Process2Wipe® IPA70 is a 70% USP IPA in Water for Injection saturated wipe
used for both aseptic and non-aseptic wipe downs of filling and packaging machinery,
stainless surfaces, Lexan, polycarbonate, glass and any critical surface requiring to be cleaned.
Product is available sterile and non-sterile
WIPES
Used for the decontamination of items such as gloves, surfaces, carts, counter tops,
process lines, and many other applications that require the use of a sterile alcohol solution
wipe that is made with USP Water for Injection.
VEL12-12X12-S-3010
• Available in 70% USP IPA in USP Water for Injection
• Class 10 Cleanliness
• Class 10 Laundered
• Reduced VOC’s
• Ideal for product spills
• Validated Sterile to 10-6 SAL
• Delivered with lot specific Certificate of Irradiation, Certificate of Analysis,
LAL Testing Analysis and Sterility Report
• 12x12 size
•Re-sealable package
Order#
Description
VEL12-12X12-3022
VEL12-12X12-S-3023
Process2Wipe IPA70 Non-Sterile 12”x12”
Process2Wipe® IPA70 Sterile 12”x12”
®
Quan/cs.
200
200
(UPON REQUEST)
Process2Wipe Product Validation
Technical Data File
42
1-888-4-STERILE
1-888-478-3745
P R O C E S S 2 W I P E ® L C I PA 7 0
GAMMA IRRADIATED TO 10-6 SAL USP 70% IPA in DI Water
Process2Wipe® IPA70 is a 70% USP IPA in DI Water saturated wipe used for both aseptic and
non-aseptic wipe downs of filling and packaging machinery, stainless surfaces, Lexan,
polycarbonate, glass and any critical surface requiring to be cleaned. Product is available sterile
and non-sterile
WIPES
Used for the decontamination of items such as gloves, surfaces, carts, counter tops,
process lines, and many other applications that require the use of a sterile alcohol solution
wipe that is made with DI water.
• Reduced VOC’s
• Ideal for abrasive surfaces
• Validated Sterile to 10-6 SAL
• Delivered with lot specific Certificate of Irradiation, Certificate of Analysis,
LAL Testing Analysis and Sterility Report
• 9x9 size
PROCESS 2 WIPE LC
Gamma Irradiated to 106 SAL USP 70% IPA and 30% DI Water
Order#
Description
P2W-LC-70DI
P2W-LCS-70DI
Quan/cs.
Process2Wipe IPA70 Non-Sterile 9”x9”
Process2Wipe® IPA70 Sterile 9”x9”
800
800
®
(UPON REQUEST)
Process2Wipe LC
Technical Data File
43
HYPO-CHLOR® WIPE
SATURATED SODIUM HYPOCHLORITE WIPE
in Water for Injection
WIPES
HYPO-CHLOR Wipe 0.25% or 0.52% are superior saturated sodium hypochlorite wipes
used for both aseptic and non-aseptic wipe downs of filling and packaging machinery, stainless
steel surfaces, Lexan, polycarbonate, glass and any critical surface requiring to be cleaned. The
unique and patented Asepti-Fill system assures sterility of the wipes contained. HYPO-CHLOR
wipe is the first sterile sodium hypochlorite wipe in the marketplace.
The use of HYPO-CHLOR Wipes is normally for intricate, or sensitive locations where a
spray down that would create an overage of residue that is not desired. HYPO-CHLOR Wipes
answer these difficult decontamination situations.
HYPO-CHLOR:
VEL9-12x12-S-3018
• Eliminates the use of a non-sterile, non-filtered sodium hypochlorite wipe in operations
• Enables the reduction of spraying of sodium hypochlorite on sensitive machinery
• Ultra Absorbent Wipe Material
• Available in 0.25%, 0.52%
• Delivered with lot specific Certificate of Analysis and Cetificate of Sterility
• 12x12 size
Order#
Description
VEL9-12X12-3021
VEL9-12X12-S-3020
VEL9-12X12-3019
VEL9-12X12-S-3018
HYPO-CHLOR
HYPO-CHLOR®
HYPO-CHLOR®
HYPO-CHLOR®
®
Quan/cs.
0.25%
0.25%
0.52%
0.52%
Wipe
Wipe
Wipe
Wipe
Non-Sterile
Sterile
Non-Sterile
Sterile
200
200
200
200
(UPON REQUEST)
Hypo-Chlor Product Validation
Technical Data File
44
1-888-4-STERILE
1-888-478-3745
DECON-CLEAN® WIPE
SATURATED CLEANING AGENT WIPE IN WATER
FOR INJECTION
WIPES
DECON-CLEAN wipe RTU is a superior saturated wipe designed to remove residue from disinfecting agents. It is used on both aseptic and non-aseptic wipe downs of filling and packaging
machinery, stainless steel, lexan, polycarbonate, glass and any critical surface requiring to be
cleaned. The unique and patented Asepti-Fill System and gamma irridation processing assures
sterility of the wipes contained. DECON-CLEAN wipes are excellent for use on process machinery and leave no residue.
The use of DECON-CLEAN wipes is normally for areas that require the assurance of a surface
that is free from cleaning agents and product residues.
DECON-CLEAN wipes:
• Class 1 laundered
• Class 10 cleanliness
• Ultra absorbant wipe material
• Delivered with lot specific Certificate of Analysis and Certificate of Sterility and
Certificate of Irradiation
• 12x12 size
Order#
Description
VEL14-12x12-S-4002
VEL14-12x12-4003
DECON-CLEAN Wipe 12”x12” Sterile
DECON-CLEAN Wipe 12”x12” Non-Sterile
Quan/cs.
200
200
(UPON REQUEST)
DECON-CLEAN Product Validation
Technical Data File
45
STERI-PEROX® WIPE
SATURATED HYDROGEN PEROXIDE WIPE
WIPES
STERI-PEROX Wipe is a superior saturated Hydrogen Peroxide wipe used for both aseptic and
non-aseptic wipe downs of filling and packaging machinery, stainless steel surfaces, Lexan,
polycarbonate, glass and any critical surface requiring to be cleaned. The unique and patented
Asepti-Fill system and gamma irrradiation processing assures sterility of the wipes contained.
STERI-PEROX Wipe is the first sterile hydrogen peroxide wipe in the marketplace. STERI-PEROX
Wipes is an excellent replacement for 70% IPA wipes on process machinery and leaves no
residue.
The use of STERI-PEROX Wipes is normally for broad and intricate locations where the desire to
reduce possible VOC’s is required. STERI-PEROX Wipes answer these difficult decontamination
situations.
STERI-PEROX:
• Reduces VOC’s by reducing the level of IPA or EtOH wipes
• Available in 6% and 3% Formulation
• Ready-to-use
• Delivered with lot specific Certificate of Analysis and Cetificate of Sterility
• 12x12 size
Order#
Description
VEL10-12X12-S-3014
VEL10-12X12-3015
VEL10-12X12-S-3016
VEL10-12X12-3017
STERI-PEROX
STERI-PEROX
STERI-PEROX
STERI-PEROX
3%
3%
6%
6%
Quan/cs.
Wipe
Wipe
Wipe
Wipe
Sterile
Non-Sterile
Sterile
Non-Sterile
200
200
200
200
(UPON REQUEST)
Steri-Perox Product Validation
Technical Data File
46
1-888-4-STERILE
1-888-478-3745
ALCOH-WIPE® SINGLES
SATURATED WITH 70% USP ISOPROPYL ALCOHOL
ALCOH-WIPE‚ is designed for sterile operations that demand the use of an individually packaged sterile saturated wipe.
ALCOH-WIPE IS:
ALCOH-WIPE
Order#
VEL6-12x12-2301
VEL6-12x12-S-2302
VEL6-12x12-S-2310
VEL6-12x12-S-2320
VEL6-18x18-2303
VEL6-18x18-2304
VEL6-6x6-2305
VEL6-6x6S--2307
Description
Alcoh
Alcoh
Alcoh
Alcoh
Alcoh
Alcoh
Alcoh
Alcoh
Wipe
Wipe
Wipe
Wipe
Wipe
Wipe
Wipe
Wipe
with
with
with
with
with
with
with
with
WIPES
• Saturated with DECON-AHOL®‚ WFI 70% USP Isopropyl Alcohol
• Individually packaged sterile wipe
• Available in a variety of sizes:
6 inch x 6 inch
12 inch x 12 inch
18 inch x 18 inch
• A polyester blend that is inherently low in particulate and shedding features
• Excellent for pharmaceutical and biotechnology industries
• Gamma irradiated through a validated cycle
• Delivered with lot specific Certificate of Irradiation, Certificate of Analysis and Sterility Test Report
• Folded for easy removal
Quan/cs.
70%
70%
91%
70%
70%
70%
70%
70%
DECON-AHOL WFI 12”x12” Non-Strerile
DECON-AHOL WFI 12”x12” Sterile
STER-AHOL WFI 12”x12” Sterile
DECON-AHOL WFI 18”x18” Non-Sterile
DECON-AHOL WFI 6”x6” Non-Sterile
100
100
100
100
100
100
100
100
(UPON REQUEST)
ALCOH-WIPE/ALCOH-GLOVE Product Validation
Technical Data File
47
ALCOH-GLOVE®
STERILE SINGLES
SATURATED WITH 70% USP ISOPROPYL ALCOHOL
ALCOH-GLOVE‚ is designed for sterile operations that demand the use of an individually
packaged sterile saturated wipe.
WIPES
ALCOH-GLOVE IS:
AG-04-70%-9053
• Remarkable innovation that resembles a dust mitten
• A non-linting, non-shedding polyester tube that is sewn at one end and then turned inside out
• Contoured to provide 100% coverage of the hand
• Saturated with DECON-AHOL WFI 70% USP Isopropyl Alcohol
• Individually packaged sterile wipe
• Gamma irradiated through a validated cycle
• Delivered with lot specific Certificate of Irradiation, Certificate of Analysis and Sterility Test Report
Order#
AG-01-70%-9050
AG-03-70%-9052
AG-05-9055
AG-06-9056
AG-02-70%-9051
AG-02-85%-9054
AG-04-70%-9053
Description
Quan/cs.
Dry Glove Wiper 1/pk Non-Steril
Dry Glove Wiper 1/pk Sterile
Dry Glove Wiper 20/pk Non-Sterile
Dry Glove Wiper 20/pk Sterile
Alcoh Glove with 70% DECON-AHOL WFI 1/pk Sterile
(UPON REQUEST)
ALCOH-WIPE/ALCOH-GLOVE Product Validation
Technical Data File
48
1-888-4-STERILE
1-888-478-3745
100
100
100
100
100
100
100
D A S - W I P E® 1 0 0
CLEAN ROOM FORMULA
DAS-WIPE 100 is a saturated 12 inch x 12 inch flat wipe.
DAS-WIPE 100 is:
WIPES
• Saturated with our stainless steel cleaner and lubricant with low remaining residues
that can be removed with an IPA wipedown
• Designed to replace silicon on turntables, process lines and as a general lubricant
• Designed to assure bottles do not stick during movement towards a critical fill site
• Made of a polyester blend inherently low in particulate and shedding features
• 12x12 size
USES: DAS-WIPE 100 is used for the cleaning of Stainless Steel
• Used for turntable lubrication and cleaning
Order#
Description
Quan/cs.
DW100-12X12-S-2319 DAS-Wipe 100 Wipes Sterile 12" x 12" 1/pk
DW100-12X12-S-2321 DAS-Wipe 100 Lubricating Wipes 2/pk
100
100
(UPON REQUEST)
Hypo-Chlor Product Validation
Technical Data File
49
S T E E L - B R I G H T® W I P E
STEEL-BRIGHT sterile stainless steel cleaner for use within the aseptic manufacturing area.
STEEL-BRIGHT is:
WIPES
• Used for removal of chemical residues, spotting and staining on stainless steel surfaces without
leaving a powdery residue
• Emulsion based USDA Authorized (A7) cleaner that will not rainbow or accumulate to a heavy
build up
USES: STEEL-BRIGHT is used for the cleaning of:
• Stainless steel
• Chrome
• Brass
• Aluminum
• Copper
SBW-12X12-S-2315
STEEL-BRIGHT Wipes Sterile 12" x 12" 1/pk
100
(UPON REQUEST)
Steel Bright Product Validation
Technical Data File
50
1-888-4-STERILE
1-888-478-3745
W I P EDOWN ® H C
THE SUPERIOR METHODOLOGY FOR PERFORMING
USP <797> COMPLAINT WIPE DOWNS
WipeDown® HC is a superior dry cleaning wipe used for surface cleanups, IPA wipe downs,
cleaning and decontaminating of primary engineering control equipment, stainless steel surfaces,
lexan, polycarbonate, glass and any other critical surface requiring to be cleaned.
WIPES
• Polycellulose blend dry wipe that incorporates Class 100 cleanliness
• Low particulates and non-shedding features.
• 9x9 size
• Sterile and Non-Sterile Version available
• Sterile version is terminally sterilized
• Each order is delivered with the lot specific Certificate of Irradiation and
Certificate of Sterility (current USP compendium).
• 55% polyester and 45% cellulose spunlaced blend that is especially clean and absorbent.
• Particulate, residues and foreign matter are effectively entrapped in the engineered design
of the material.
• Construction and pattern has been developed to ensure the greatest product integrity and
cleaning performance.
• Non-shedding edges are heat sealed.
WipeDown HC clean room wipes are extremely low in particle shedding and soluble
extractables. Each pack is inspected and sealed in ultra clean packages within class
100 conditions. WipeDown HC clean room wipes are your choice to meet the highest
cleanroom standards.
Order#
Description
Quan/cs.
VEL13-9X9-S-3013
WipeDown® HC Dry Wipe Sterile- 20 wipes/pack,
20 packs/case
400
VEL13-9X9-NS-HC-3024 WipeDown® HC Dry Wipe Non-Sterile- 300 wipes/pack,
5 packs/case (packaged flat)
1000
(UPON REQUEST)
Technical Data File
51
PROCESS
CLEAN
Clean In Place (Process2Clean)
F O R C R I T I C A L C L E A N I N P L A C E A P P L I C AT I O N S
WELCOME TO PROCESS2CLEAN
P
rocess2Clean products have been specifically designed for critical process cleaning applications. In this
venue, the appropriate use of process cleaning cleaners warrants two concerns. The first concern relates to the
ability of the specific detergent to remove existent product residues that may exist in either open or closed
processes manufacturing equipment and vessels. The second concern is the ability to rinse free the product residue,
any contamination that has entered and the process cleaning detergent itself to assure that such surfaces are clean prior
to the formulation and manufacturing of a new lot of product. In short, if one introduces contamination, may it be
viable, non-viable or residual, then one must assure its removal. To address the lowering of contamination,
Process2Clean products are available in both sterile and non-sterile packaging configurations. The sterile version
CIP
eliminates the concern for unwanted particulates, microorganisms and pyrogens that may be introduced through the
Process Cleaning detergent chemical.
Process2Clean products have been engineered to effectively remove a multitude of product residues. All products
are manufactured and tested from beginning to end in our GMP manufacturing facility that meets the highest standard in
manufacturing, processing and testing. All products are made in controlled environments. This assures the highest level
of quality and cleanliness of the final product.
In an effort to assist your validation efforts, Veltek offers a comprehensive cleaning validation support package
specific to all VAI process cleaners. Controlled documents include but are not limited to; analytical (specific and nonspecific) methods for detergent residue detection, last-to-rinse reports, conductivity and TOC curves, substrate compatibility reports, product toxicity reports and more.
52
1-888-4-STERILE
1-888-478-3745
PROCESS CLEAN
1
PROCESS 2 CLEAN 1
ALKALINE DETERGENT
Available in Sterile and Non-Sterile Formulations
Process2Clean 1 is a high performance concentrated liquid alkaline cleaning agent
designed specifically for the pharmaceutical, biotechnology, cosmetic, medical device
and research & development industries.
Applications
Process2Clean 1 is optimally formulated for use on all process and laboratory
equipment in automated wash and soak applications. It is extremely effective
in cleaning a wide assortment of soils including but not limited to protein,
excipients, silicones, ointments, creams, oils, waxes, greases, petrolatumbased products and most all other types of organic material.
CIP
The unique formulation of chelants and proprietary surfactants in this
premium detergent provide a stabilized formula that is capable of cleaning a
multitude of product and non-product contact surfaces. Process2Clean 1 is phosphate
free and is compatible for use on stainless steel surfaces, glass, soft metals, plastics
and a wide range of elastomers.
Typical use dilution is .5-5%. Precise temperature, concentration and cleaning time will
depend on the degree and type of soil present. All surfaces should be rinsed thoroughly
to remove all product and soil residue following cleaning.
Features
Benefits
Contains chelating agents
Hard water tolerant
Contains premium surfactants
Great wetting ability for optimal penetration
Highly concentrated
Low cost per use
No foaming
Ideal for optimal automated cleaning
Lot specific documentation package
Product consistency and integrity
Optimal formulation
Eliminates the need for hazardous organic solvent
Phosphate free
Ecologically safe
An extensive validation support package that includes Last-to-Rinse studies and analytical methods of detection
[specific and non-specific] are available to compliment VAI’s CORE (Critical Ongoing Residue Evaluation)
laboratory “soil” testing. Veltek’s comprehensive pharma program enables us to customize an optimal cleaning
program to meet your specific process needs.
Available in 1, 5, 30, 55, and 275 gallon containers. Most product sizes are available in sterile or non-sterile formula.
53
PROCESS CLEAN
1
Specifications
Appearance
Odor
Detergency
Specific Gravity
pH @ 1% Solution (normal)
Solubility
Foaming
Rinsing
Biodegradable
Storage Recommendation
P Content
N Content
Flash Point
Conductivity
Colorless Clear Liquid
Slight Chemical
Excellent
1.35
12.5
Complete
Minimal to none
Excellent
Yes
40°F – 90°F
0.00%
0.00%
Not Applicable
12.2 mS/cm (1% deionized water) @ 21°C
CIP
Material Compatibility
Under the recommended application conditions Process2Clean 1 is suitable for use with stainless steel, glass,
enamel, plastics and most elastomers at recommended use dilutions.
Safety
For cautionary and first aid information, consult the material safety data sheet or product label. Please contact
your Veltek sales consultant for further safety and or use recommendations.
Contact VAI customer service for recycling options offered for 30 gallon, 55 gallon and 275 gallon containers.
Standard Ordering Information
Order Number
Description
PC-1-275G-01
PC-1-55G-01
PC-1-55G-02
PC-1-30G-01
PC-1-30G-02
PC-1-5G-01
PC-1-5G-02
PC-1-1G-01
PC-1-1G-02
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
1
1
1
1
1
1
1
1
1
Container Size
Non-Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
275 Gallon
55 Gallon
55 Gallon
30 Gallon
30 Gallon
5 Gallon
5 Gallon
1 Gallon
1 Gallon
Qty. per case
1
1
1
1
1
1
1
4
4
Lot Specific Documentation Package
All product is lot traceable and delivered each time with the lot specific certification.
All lots are traced through the master batch records.
ADDITIONAL SUPPORT DOCUMENTATION PACKAGES
(AVAILABLE UPON REQUEST)
Sample Lot Specific Certification
Technical Product PDF File
Material Safety Data Sheet
Product Cleaning Validation Report
Product Sterility Validation Report
Analytical COAs
Last-to-Rinse Reports
Specific and Non-Specific Analytical Test Methods for Detection
54
1-888-4-STERILE
1-888-478-3745
PROCESS CLEAN
2
PROCESS 2 CLEAN 2
ACID DETERGENT
Process2Clean 2 is a high performance concentrated liquid phosphoric acid
cleaning agent designed specifically for the pharmaceutical, biotechnology,
cosmetic, medical device and research & development industries.
Applications
Process2Clean 2 is optimally formulated for use on all process and
laboratory equipment in automated wash and soak applications. It is
extremely effective in cleaning a wide assortment of soils including but not
limited to inorganic salts, scales, particulate carbon, proteins, excipients, fine
chemicals, silicones, oils, petrolatum, polymers and most all types of
organics. This product is especially effective on antacid formulations.
Routine use of this product reduces corrosion, pitting and rusting.
CIP
The unique formulation of this premium detergent provides a stabilized formula that is capable
of cleaning a multitude of product and non-product surfaces. Process2Clean 2 is compatible
for use on stainless steel, glass and a wide variety of plastic surfaces.
Typical use dilution is .5 - 5%. Precise temperature, concentration and cleaning time will
depend on the degree and type of soil present. All surfaces should be rinsed thoroughly to
remove all product and soil residue following cleaning.
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
No foaming
Optimal formulation
Eliminates the need for hazardous organic solvents
An extensive validation support package including Last-to-Rinse studies and specific and non-specific analytical
product residue detection methods are available and compliment VAI’s CORE (Critical Ongoing Residue
Evaluation) Laboratory program that can assist with customized testing to meet your specific needs.
Available in 1, 5, 30,55 and 275 gallon containers. Most product sizes are available in sterile or non-sterile formula.
55
PROCESS CLEAN
2
Specifications
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
P Content
N Content
Flash Point
Conductivity
Slight Chemical
Excellent
1.27
1.92
Complete
Minimal to none
Excellent
Yes
32°F – 90°F
29.7%
0.00%
Not Applicable
CIP
Under the recommended application conditions Process2Clean 2 is suitable for use with stainless steel, glass
and most elastomers.
Safety
For cautionary and first aid information, consult the material safety data sheet or product label. Please contact
your Veltek sales consultant for further safety and or use recommendations.
Contact VAI Customer Service for recycling options offered for 30, 55 and 275 gallon containers.
Order Number
Description
PC-2-275G-01
PC-2-55G-01
PC-2-55G-02
PC-2-30G-01
PC-2-30G-02
PC-2-5G-01
PC-2-5G-02
PC-2-1G-01
PC-2-1G-02
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
2
2
2
2
2
2
2
2
2
Container Size
Non-Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
275 Gallon
55 Gallon
55 Gallon
30 Gallon
30 Gallon
5 Gallon
5 Gallon
1 Gallon
1 Gallon
Qty. per case
1
1
1
1
1
1
1
4
4
Analytical COAs
56
1-888-4-STERILE
1-888-478-3745
PROCESS CLEAN
3
PROCESS 2 CLEAN 3
H Y D R O X YA C E T I C A C I D D E T E R G E N T
Process2Clean 3 is a high performance concentrated liquid hydroxyacetic acid
cleaning agent designed specifically for the pharmaceutical, biotechnology, cosmetic, medical device and research & development industries.
Applications
equipment in automated wash, spray and soak applications. It is extremely
effective in cleaning a wide assortment of soils including but not limited to
inorganic salts, scales, particulate carbon, proteins, excipients and most all
types of inorganics. This product is especially effective on antacid formulations.
Routine use of this product reduces corrosion, pitting and rusting.
CIP
The unique formulation of this premium detergent provides a stabilized formula that is capable of
cleaning a multitude of product and non-product surfaces. Process2Clean 3 is compatible for use
on stainless steel, glass and a wide variety of plastic and elastomer surfaces.
Typical use dilution is .5 - 5%. Precise temperature, concentration and cleaning time will depend
on the degree and type of soil present. All surfaces should be rinsed thoroughly to remove all
product and soil residue following cleaning.
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
No foaming
Optimal formulation
Contains no phosphates
Ecologically safe
Available in 1, 5, 30, 55, and 275 gallon containers.
57
PROCESS CLEAN
3
Specifications
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
P Content
N Content
Flash Point
Conductivity
Pale Yellow to Amber Liquid
Slight Chemical
Excellent
1.12
2.8
Complete
Minimal to none
Excellent
Yes
32°F – 90°F
0.00%
0.00%
Not Applicable
CIP
Under the recommended application conditions Process2Clean 3 is suitable for use with stainless steel, glass,
plastics and most elastomers, at recommended use dilutions.
Safety
For cautionary and first aid information, consult the material safety data sheet or product label.
Please contact your Veltek sales consultant for further safety and or use recommendations.
Order Number
Description
PC-3-275G-01
PC-3-55G-01
PC-3-55G-02
PC-3-30G-01
PC-3-30G-02
PC-3-5G-01
PC-3-5G-02
PC-3-1G-01
PC-3-1G-02
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
3
3
3
3
3
3
3
3
3
Container Size
Non-Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
275 Gallon
55 Gallon
55 Gallon
30 Gallon
30 Gallon
5 Gallon
5 Gallon
1 Gallon
1 Gallon
Qty. per case
1
1
1
1
1
1
1
4
4
Analytical COAs
58
1-888-4-STERILE
1-888-478-3745
PROCESS CLEAN
4
PROCESS 2 CLEAN 4
GENERAL PURPOSE DETERGENT
Process2Clean 4 is a high performance neutral liquid general cleaning agent
designed specifically for the pharmaceutical, biotechnology, cosmetic,
medical device, research & development and life science industries.
Process2Clean 4 is a neutral pH detergent with foaming properties.
Applications
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
Mild
Cleans most all surfaces safely & effectively
Biodegradable & Phosphate Free
Ecologically safe
Optimal formulation
CIP
Process2Clean 4 is optimally formulated for use on all process and laboratory equipment in low agitation, spray, soak, foam and manual cleaning
applications. It is extremely effective in cleaning a wide assortment of soils
including but not limited to ointments, creams, oils, waxes, greases most
all other types of inorganic material and petrolatum-based products.
Process2Clean 4 is also an excellent environmental cleaner for use on
equipment, exteriors, walls, floors and ceilings. The unique formulation of
chelants and proprietary surfactant in this premium detergent provide a stabilized formula that is capable of
cleaning a multitude of product and non-product contact surfaces. Process2Clean 4 is phosphate free and is
compatible for use on most all process and environmental surfaces, Process2Clean 4 is not suitable for
automated recirculation cleaning applications. Typical use dilution is .5 to 5%. Precise temperature,
concentration and cleaning time will depend on the degree and type of soil present. All surfaces should be
rinsed thoroughly to remove all product and soil residue following cleaning.
An extensive validation support package is available including Last-to-Rinse studies and specific and non-specific
analytical product residue detection methods are available and is complimented with VAI’s CORE (Critical Ongoing
Residue Evaluation)) Laboratory that can assist with customized testing to meet your specific needs.
59
PROCESS CLEAN
4
Specifications
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
P Content
N Content
Flash Point
Conductivity
Amber Liquid
Slight Chemical
Excellent
1.09
8.5
Complete
Moderate - high
Excellent
Yes
32°F – 90°F
0.00%
0.00%
Not Applicable
CIP
Process2Clean 4 is suitable for use with stainless steel, soft metals, plastics, enamel, glass, ceramic and most
all elastomer surfaces at the recommended use dilution.
Safety
Order Number
Description
PC-4-275G-01
PC-4-55G-01
PC-4-55G-02
PC-4-30G-01
PC-4-30G-02
PC-4-5G-01
PC-4-5G-02
PC-4-1G-01
PC-4-1G-02
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
4
4
4
4
4
4
4
4
4
Container Size
Non-Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
275 Gallon
55 Gallon
55 Gallon
30 Gallon
30 Gallon
5 Gallon
5 Gallon
1 Gallon
1 Gallon
Qty. per case
1
1
1
1
1
1
1
4
4
Analytical COAs
60
1-888-4-STERILE
1-888-478-3745
PROCESS CLEAN
5
PROCESS 2 CLEAN 5
NEUTRAL pH CLEANING ADDITIVE
Process2Clean 5 is a high performance concentrated liquid neutral pH stand alone or
cleaning additive detergent agent designed specifically for the pharmaceutical,
biotechnology, cosmetic, medical device and research & development industries.
Applications
equipment in automated wash, spray and soak applications. Process2Clean
5 may be used as an additive in conjunction with other detergents, or as a
stand alone detergent. It is extremely effective in cleaning a wide assortment
of soils including but not limited to protein, excipients, silicones, ointments,
creams, oils, waxes, greases, petrolatum-based products and most all other
types of inorganic material.
CIP
The unique formulation of chelants and proprietary surfactants in this premium detergent provide a
stabilized formula that is capable of cleaning a multitude of product and non-product surfaces.
Process2Clean 5 is phosphate free and is compatible for use on most all substrate material.
Typical use dilution is .5-5%. Precise temperature, concentration and cleaning time will depend on
the degree and type of soil present. All surfaces should be rinsed thoroughly to remove all product
and soil residue following cleaning.
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
No foaming
Ideal for optimal automated cleaning (see specifications)
Optimal formulation
Ecologically safe
61
PROCESS CLEAN
5
Specifications
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
P Content
N Content
Flash Point
Conductivity
Amber Liquid
Slight Chemical
Excellent
1.01
8.4
Complete
Minimal - cloud point at 120°F
Excellent
Yes
32°F – 90°F
0.00%
0.00%
Not Applicable
CIP
Under the recommended application conditions Process2Clean 5 is suitable for use with
stainless steel, soft metals, glass, plastics, enamel and most all elastomer surfaces.
Safety
Order Number
Description
PC-5-275G-01
PC-5-55G-01
PC-5-55G-02
PC-5-30G-01
PC-5-30G-02
PC-5-5G-01
PC-5-5G-02
PC-5-1G-01
PC-5-1G-02
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
5
5
5
5
5
5
5
5
5
Container Size
Non-Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
275 Gallon
55 Gallon
55 Gallon
30 Gallon
30 Gallon
5 Gallon
5 Gallon
1 Gallon
1 Gallon
Qty. per case
1
1
1
1
1
1
1
4
4
Analytical COAs
62
1-888-4-STERILE
1-888-478-3745
PROCESS CLEAN
6
PROCESS 2 CLEAN 6
CHLORINATED ALKALINE DETERGENT
Process2Clean 6 is a high performance concentrated liquid chlorinated alkaline
cleaning agent designed specifically for the pharmaceutical, biotechnology,
cosmetic, medical device research & development and lab animal reaearch industries.
Applications
equipment in automated wash, spray, soak and manual applications. It is
extremely effective in cleaning a wide assortment of soils including but not
limited to protein, excipients, silicones, ointments, creams, oils, waxes,
greases, petrolatum-based products,animal fats and most all other organic
material.
CIP
The unique formulation of chelants and proprietary surfactants in this premium
detergent provide a stabilized formula that is capable of cleaning a multitude of product and non-product contact
surfaces. Process2Clean 6 is compatible for use on stainless steel, glass and most elastomers and contains a buffering agent promoting substrate integrity.
Typical use dilution is .5-5%. Precise temperature, concentration and cleaning time will depend on the degree and
type of soil present. All surfaces should be rinsed thoroughly to remove all product and soil residue following cleaning.
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
No foaming
Optimal formulation
Contains buffering agent
Promotes substrate integrity
Ecologically safe
An extensive validation support package that includes Last-to-Rinse studies and analytical methods of detection
[specific and non-specific] are available to compliment VAI’s CORE (Critical Ongoing Residue Evaluation)
laboratory “soil” testing. Veltek’s comprehensive pharma program enables us to customize an optimal cleaning program to meet your specific process needs.
63
PROCESS CLEAN
6
Specifications
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
Cl2 Content
P Content
N Content
Flash Point
Conductivity
Amber Clear Liquid
Chlorine
Excellent
1.2
12.6
Complete
Minimal to none
Excellent
Yes
32°F – 80°F
1.5 – 2.5 %
0.00%
0.00%
Not Applicable
CIP
Under the recommended application conditions Process2Clean 6 is suitable for use with
stainless steel, glass, plastics and most elastomers.
Safety
Contact VAI Customer Service for recycling options offered for 275 gallon container.
Order Number
Description
PC-6-275G-01
PC-6-55G-01
PC-6-55G-02
PC-6-30G-01
PC-6-30G-02
PC-6-5G-01
PC-6-5G-02
PC-6-1G-01
PC-6-1G-02
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
Process2Clean
6
6
6
6
5
6
6
6
6
Container Size
Non-Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
Non-Sterile
Sterile
275 Gallon
55 Gallon
55 Gallon
30 Gallon
30 Gallon
5 Gallon
5 Gallon
1 Gallon
1 Gallon
Qty. per case
1
1
1
1
1
1
1
4
4
Analytical COAs
64
1-888-4-STERILE
1-888-478-3745
CAGE WASH
C
age2Wash products have been specifically designed for critical animal facility, component and animal cage
washing applications. In this venue, the appropriate use of a cleaning agent to remove animal waste and
animal by-products is critical. The use of a cleaning agent in this venue warrants an end user to concern
themselves with the ability of the specific detergent to remove the existent residues. These residues may be in the
form of urine, scales, animal fats, oils, organics and other related animal by-products or formulated drug product
residues. Such residues need to be effectively removed through a variety of application methodologies that include
rinsing, high pressure spray, circulation and immersion. The removal of past product residues and/or animal by-products
Clean In Place (Cage2Wash)
W E L C O M E T O C A G E 2 WA S H
protects the integrity of new product lots and animals that may be placed into the cages. Cage2Wash products also have
compromising the system. These concerns are critical considerations for lab animal research and lab animal housing facilities.
Cage2Wash products have been engineered to effectively remove a multitude of product residues. All products are
formulated under the highest quality standards in our GMP manufacturing facility and are offered in both sterile and
non-sterile formulations.
65
CIP
the ability to rinse free from the surfaces thus eliminating the possibility of the residual from the cleaner itself
CAGE WASH
1
C A G E 2 WA S H 1
ALKALINE DETERGENT
Cage2Wash 1 is a high performance concentrated liquid alkaline cleaning agent
designed specifically for the life science and research and development industries.
Applications
Cage2Wash 1 is optimally formulated for use on all process, caging and laboratory
equipment in automated wash, spray and soak applications. It is extremely
effective in cleaning a wide assortment of soils including but not limited to
protein, fats, oils, serums, and most all other types of organic material.
CIP
The unique formulation of chelating agent and proprietary surfactant system
ingredients in this premium detergent provide a stabilized formula that is
capable of cleaning a multitude of soils including but not limited to product
and non-product surfaces. Cage2Wash 1 is phosphate free and is compatible
for use on stainless steel, glass, soft metals, polycarbonate polypropylene, and a wide range
of plastics.
Typical use dilution is 0.25 - 3%. Precise temperature, concentration and cleaning
time will depend on the degree and type of soil present. All surfaces should be
rinsed thoroughly to remove all product and soil residue following cleaning.
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
No foaming
Optimal formulation
Phosphate free
Ecologically safe
Available in 1, 5, 30, 55, and 275 gallon containers. .
66
1-888-4-STERILE
1-888-478-3745
CAGE WASH
1
Specifications
Slight Chemical
Excellent
1.35
12.5
Complete
Minimal
Excellent
Yes
32°F – 90°F
0.00%
0.00%
Not Applicable
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
P Content
N Content
Flash Point
Conductivity
CIP
Under the recommended use applications Cage2Wash1 is suitable for use with stainless steel,
glass, soft metals, plastics and most elastomers.
Safety
Order Number
Description
C-1-275G-01
C-1-55G-01
C-1-30G-01
C-1-5G-01
C-1-1G-01
Cage2Wash
Cage2Wash
Cage2Wash
Cage2Wash
Cage2Wash
1
1
1
1
1
Container Size
Non-Sterile
Non-Sterile
Non-Sterile
Non-Sterile
Non-Sterile
275 Gallon
55 Gallon
30 Gallon
5 Gallon
1 Gallon
Qty. per case
1
1
1
1
4
Analytical COAs
67
CAGE WASH
2
C A G E 2 WA S H 2
ENHANCED ALKALINE DETERGENT
Specifically Designed for Animal Research and Manufacturing Facilities
Cage2Wash 2 is an enhanced high performance concentrated liquid mild alkaline
cleaning agent designed specifically for the animal research, life science,
research & development and manufacturing industries.
Applications
Cage2Wash 2 is optimally formulated for use on all process caging and laboratory
equipment in automated wash and soak applications. It is extremely effective
in cleaning a wide assortment of soils including but not limited to protein,
serums, urine scales, animal fats and most all other types of organic material.
CIP
The unique ingredients in this premium detergent provide a stabilized formula
that is capable of cleaning a multitude of product and non-product surfaces.
Cage2Wash 2 is phosphate free and is compatible for use on stainless steel,
soft metals, polycarbonate polypropylene and a whole assortment of other plastics.
Typical use dilution is .25 - 3%. Precise temperature, concentration and cleaning time will
depend on the degree and type of soil present. All surfaces should be rinsed thoroughly
to remove all product and soil residue following cleaning.
Features
Benefits
Hard water tolerant
Highly concentrated
Low cost per use
No foaming
Optimal formulation
Contains buffering agents
Maintain substrate integrity
Phosphate free
Ecologically safe
Available in 1, 5, 30, 55, and 275 gallon containers.
68
1-888-4-STERILE
1-888-478-3745
2
CAGE WASH
Specifications
Slight Chemical
Excellent
1.06
10.9
Complete
Minimal to none
Excellent
Yes
32°F – 90°F
0.00%
0.00%
Not Applicable
Safety
Contact VAI Customer Service for recycling options offered for 30, 55 and 275 gallon containers
Order Number
Description
C-2-275G-01
C-2-55G-01
C-2-30G-01
C-2-5G-01
C-2-1G-01
Cage2Wash
Cage2Wash
Cage2Wash
Cage2Wash
Cage2Wash
2
2
2
2
2
Container Size
Non-Sterile
Non-Sterile
Non-Sterile
Non-Sterile
Non-Sterile
275 Gallon
55 Gallon
30 Gallon
5 Gallon
1 Gallon
Qty. per case
1
1
1
1
4
Analytical COAs
69
CIP
Under the recommended use applications Cage2Wash 2 is suitable for use with stainless steel, soft metals,
glass, enamel, polycarbonate, polysulfone and a wide range of other plastic substrates and elastomers.
Appearance
Odor
Detergency
Specific Gravity
Solubility
Foaming
Rinsing
Biodegradable
P Content
N Content
Flash Point
Specific Conductivity

Veltek Associates Catalog

Transcription

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