decon-ahol wfi and ster-ahol wfi - sterile.com

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Veltek Associates, Inc. TDR-9000 03/03 1039 West Bridge Street Phoenixville, PA 19460-4218 USA Tel: (610) 983-4949 Fax: (610) 983-9494

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DDDECON-AHOL WFI and STER-AHOL WFI EECCOONN--AAHHOOLL WWFFII aanndd SSTTEERR--AAHHOOLL WWFFII Overview: The purpose of this report is to provide complete direction for use and selection of Veltek’s DECON-AHOL WFI and STER-AHOL WFI products. This file is supplemented with the DECON-AHOL WFI Technical Data Report (DWFI.PDF) and the STER-AHOL WFI Technical Data Report (DSTER-WFI.PDF) available from VAI sales representatives. Technical file DWFI.PDF and DSTER-WFI.PDF are specifically written to address product features, ordering, MSDS’s and basic manufacturing specifications for the products. This document intent is directed towards the use and selection of products within each product category. Product Specifications: DECON-AHOL WFI and STER-AHOL WFI DECON-AHOL WFI is manufactured in a Class 100 GMP manufacturing operation. The products are formulated with USP isopropyl or USP denatured ethanol. The product is filled and bagged in such operation and then exposed to a validated dosage of gamma radiation to render the product sterile. Each product lot is assayed, sterility tested and LAL tested to current USP compendium. Sterility testing is conducted by current USP compendium utilizing filter membrane testing and LAL testing to current USP compendium for gel clot. Product Assay specifications can be found on our lot specific Certificate of Analysis. Sterility details can be found on our Certificate of Sterility and Irradiation details can be found on our Certificate of Irradiation. And the LAL testing details can be found on our Certificate of Exdotoxin Testing. Please contact VAI Technical Support for any of these documents. All DECON-AHOL WFI products are assayed to current USP compendium as presented below: Appearance Clear colorless Assay 68.0-72.0% Acidity < 1.0 ml Nonvolatile Residue < 5.0 mg (<0.001%) Specific gravity @ 20 degrees C 0.872-0.883 All STER-AHOL WFI products are assayed to current USP compendium as presented below: Appearance Clear colorless Assay 68.0-72.0% Acidity < 1.0 ml Nonvolatile Residue < 5.0 mg (<0.001%) Specific gravity @ 20 degrees C 0.882-0.892


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DECON-AHOL WFI and STER-AHOL WFI Products are: Sterilized at an Irradiation dose of : 25.0 – 50.0 kGy Manufactured in a Class 100 Manufacturing Operation Lot Sterility Tested Lot Tested for Endotoxins Levels Both are validated for a 3-year expiration period from date of manufacture. Choosing the Right Size and Style of Container: Of critical importance is the selection of the correct container size and type of container. Based on each specific requirement in manufacturing or testing operations, some containers are better suited for the capacity than others. Below is a description of the container types and uses. Hand Held Containers: This section compares the aerosol, trigger spray and squeeze bottle containers. Veltek Associates, Inc. manufactures all container types and presents the following data in analysis of each type’s advantages and disadvantages in use.

The types of containers are:

DECON-AHOL Aerosol Mist and Stream DECON-AHOL Aerosol InvertaSpray Mist and Stream (sprays any direction) DECON-AHOL 16 oz. Trigger Spray DECON-AHOL 16 oz. Squeeze Bottle DECON-AHOL 1 Gallon and 5 Gallon DECON-AHOL 55 Gallon

With the most features is the aerosol container. Thus comparing the other containers to the aerosol container provides the best method of analysis. The aerosol container provides:

The finest level of sterility assurance of the solution over the time it is used The best coverage of the surface to be disinfected The best assurance for disinfection of the exterior of the container over use

Let’s evaluate each issue one by one.

Finest Level of Sterility Assurance Over Use of the Container: The aerosol container manufactured in accordance with VAI’s US Patent 6,123,900, Method of Sterilization, does not aspirate the room air to the master reservoir of alcohol. Simply,


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containers such as trigger sprays and squeeze bottles, when activated, will spray then suck back air into the container from the exterior environment. This can cause contamination of the solution. As the aseptic area is exactly that, aseptic, the existence of microorganisms in its environment is very probable if not for certain. This scenario presents three issues that must be addressed:

1. Sterility of the solution over use 2. Removal of trigger spray or squeeze bottles in a shorter time period than the aerosol that

will be sterile from first use till last use. 3. Cost analysis for using an aerosol, trigger spray or squeeze bottle

The aerosol container can be used from first use till last use. However, it is suggested that SOP’s be written to reflect its expiration at the “manufacturer’s expiration date”. This it to assure that a can will be used before the date of expiration stamped on the can by Veltek Associates, Inc. If for some reason a regulatory inspector would see a can with VAI’s expiration date as expired it could cause some problem. However, VAI has validation to support 6 years of assay and sterility. The removal of other containers in a shorter time period than that of the aerosol is obvious. The aerosol is a pressure vessel and nothing goes back into the container. Trigger sprays and squeeze bottles are aspirating containers and will pull external air back to the master solution. This change out of trigger sprays and squeeze bottles on a more frequent basis actually increases the price of such containers. VAI manufactures all container types (aerosol, trigger, squeeze, 1 gallon, 5 gallon and 55 gallon). Thus, VAI has no personal stake in which container one would choose. But the evidence is significant that one container can be used for a longer time period (aerosol) than others. At the end of this section is a cost analysis identifying related cost issues with all products.

The best coverage of the surface to be disinfected:

The aerosol container sprays evenly across a surface and wets such surface more efficiently than that of trigger sprays and squeeze bottles. This is an issue that end users should test for themselves. A better wetting of the surface and better coverage means better disinfection of such surface. The trigger spray requires one to continually depress the trigger to emit the alcohol. The squeeze bottle has a very small spray radius and is hard to spray to the surface and assure coverage without using mechanical wiping. In reality, the multiple depressing of the trigger or squeezing of the squeeze bottle is labor intensive and many end-user complaints of corporal tunnel syndrome as cramps of the arms occur frequently. The spray pattern of the trigger is very erratic. It does not evenly coat the surface. The aerosol container is a more defined mechanism of spray as compared to a trigger spray. It uses more expensive and exact components and thus is able to deliver a more even coat to the surface. This can be seen in the spray pattern to the surface. Added to the better wetting of the surface, the time frames for application of the IPA or EtOH to the surface are dramatically reduced with


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the aerosol container. In testing of carts that entered aseptic processing areas and laminar flow curtains, a person using an aerosol was able to complete the task each time in 50% of the time of those who were using trigger spray or squeeze bottles. This factor is significant and represents the highest cost associates with the use of IPA or EtOH, labor. To add to this cost savings in time, the carts and curtains tested via rodac of surfaces proved the aerosol applications as more effective in the reduction of existent bioburden.

In-Use Application During Production:

In some operations, the concern over the mist from an aerosol lingering into particle counters and creating false readings is a concern during manufacturing. This can also happen with a trigger spray container. Defining the use instructions and application mode for the container is critical in this venue. Elimination of this scenario can be accomplished in the aerosol by using VAI part numbers DECWFI-ST-70 or DSTER-WFI-ST-70. These are the part numbers for the STREAM version of DECON-AHOL and STER-AHOL respectively. The STREAM version precipitates out in the spray patter of a squeeze bottle. During cleaning and disinfection of the area prior to manufacturing, this should not be an issue, as the product is not exposed. Thus, the container with the best ability to wet the surface in all areas is considered the preferred choice. During manufacturing, both the trigger spray and aerosol create a mist that if negligently not controlled by the end user could be pushed by laminar flow toward particle counter probes or product. Entry of the droplet into a particle counter and being read as a particulate could occur but with proper training, should never occur. Spraying upward into the air is of no value. Spraying near a particle counter probe is also not necessary. During production there are a few uses for IPA and EtOH. The first is to disinfect gloves and the second is to spray down a surface.

Removal of trigger spray or squeeze bottles in a shorter time period than the aerosols:

In many areas, regulatory inspectors will be able to view the in-use container of IPA or EtOH in the aseptic manufacturing area. In most instances, the first question will be, “How long in that bottle used before it is discarded?” As discussed the aerosol container attributes of non-aspiration will be sufficient to satisfy the inspector’s curiosity. Thus, technically labeling it as in use until the manufacturer’s expiration date is sufficient. However, the trigger spray and squeeze bottle’s characteristic aspiration of the room air will render such expiration or disposal period as a shorter time period. Normal time periods are designated as 7-30 days. However, it is important to backup the claim with in-hose data. Data can be established in two ways:


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1. Test antimicrobial effectiveness against one’s relevant environmental isolates and then assay the same solution (bottle) after the expiration period desired to prove sterility and the existence of active ingredients.

2. Age the solution for the expiration period (say 7-30 days) and then conduct antimicrobial

effectiveness and sterility of the solution in the container. The later of the two is preferred as the kill claim at the last day of the expiration period has been tested and proven. In the first scenario, the correlation needs to be made to an inspector that the active percentage is the same as when antimicrobial effectiveness was conducted, so kill data should be the same. The key word is should that technically means “May possibly occur”. The subject of validation of disinfecting agents is completely covered in VAI Technical document val-dis98.pdf. Another regulatory implication may be the exterior of the container’s disinfection over time. Simply, “How often is the container handled by vary personnel in the production area over the use period”. Or, “Does the exterior become contaminated and how is this addressed?” Simply incorporating into SOP’s the spray down or wipe down of the container with some frequency during manufacturing should calm this request. However, the exterior surfaces of an aerosol and squeeze bottle are very smooth and easily cleaned and disinfected. The trigger spray’s surfaces are very intricate and hard to disinfect and clean. Spray down of the container is normally done with another container. This is easily done with the aerosol but more difficult with the trigger or squeeze bottle.

Cost analysis for using an aerosol, trigger spray or squeeze bottle

Identifying the costs associated with the use of each container is important. In this section two analysis’s are presented.

1. An analysis of purchasing and aerosol, trigger spray and squeeze bottle from VAI. 2. An analysis of the costs to product sterile IPA or EtOH in-house.

Let’s look at each individually.

An analysis of purchasing and aerosol, trigger spray and squeeze bottle from VAI.

Some immediately look at the cost of the case or the cost of the container (evaluating per ounce cost). This would be an inappropriate way to evaluate cost as many other factors possibly unknown to purchasing departments exist in the use of these containers in production. From the chart below, we can view the LIST prices per case:


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Container Size Cost/Case Cost/Container Cost/Ounce 11 oz. Aerosol Container $294.00 $12.25 $1.11 16 oz. Trigger Spray $144.00 $12.00 $0.75 32 oz. Trigger Spray $296.00 $24.67 $0.77 16 oz. Squeeze Bottle $192.00 $16.00 $1.00 The worldwide market mix is as follows in the industry: Aerosol 61%, Trigger Spray 28%, Squeeze Bottle 11%. If we add the following additional costs associates with the items we have previously discussed, we can see a completely different cost for each product type. The following are the additional costs known to production and QA. Issue 11 oz. Aerosol 16 oz. Trigger 16 oz. Squeeze Cost of waste due to inexact spray patterns causing more alcohol to be used to wet the surface

Very Exact with excellent coverage

Inexact causing more alcohol to

be used

Inexact causing more alcohol to be used

Cost of removal before container is completely used due to possible contamination in bottle Use Till Empty End of Shift End of Shift

Contamination due to aspiration of room air during use None Very Likely Very Likely

Possible contamination from exterior of bottle due to irregular or not able to be disinfected surfaces

Not likely Very Likely Not Likely

Chance of container falling on the ground due to instability of the container, thus requiring removal

Not likely Very Likely Very Likely

However, identifying the specific cost associated with each item may be very difficult. Most firms whom use an aerosol product use 30-40% less alcohol than firms who use a trigger spray or squeeze bottle. Most reasons are waste related or possible contamination to the interior solution (causing a full container to be removed). Most firms whom switch from an aerosol to a trigger spray use significantly more alcohol and return to the more exacting aerosol container. Using that analysis we can calculate a low-end 30% decrease in alcohol consumption and thus are presented with the following new figures. Container Size Cost/Case Cost/

ContainerCost/

Ounce Cost Reduction due to less alcohol used

New Cost Per Ounce

11 oz. Aerosol Container $294.00 $12.25 $1.11 25% $0.77 16 oz. Trigger Spray $160.00 $13.33 $0.83 0% $0.83 32 oz. Trigger Spray $296.00 $24.67 $1.54 0% $1.54 16 oz. Squeeze Bottle $192.00 $16.00 $1.00 0% $1.00


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In testing labor times for application using an aerosol and a trigger spray, the following are cost in motion studies for disinfection of a cart entering an aseptic area and vinyl curtains surrounding a laminar flow area. Item Disinfected Container Type Time Period to Wet All

Surfaces (in minutes) Labor Rate/hour

Total Cost/Item to Disinfect

Aerosol on Cart Size: 44"L x 24"W x 42" H 3 $21.00 $1.05

Trigger Spray on Cart

Size: 44"L x 24"W x 42" H 9 $21.00 $3.15

Squeeze Bottle with Wipe on Cart

Size: 44"L x 24"W x 42" H 10 $21.00 $3.50

Item Disinfected Container Type Time Period to Wet All

Surfaces (in minutes) Labor Rate/hour

Total Cost/Item to Disinfect

Aerosol on 8 curtain panels

Size: 72"L x 12"W x 0.4" D 12 $21.00 $4.20

Trigger Spray on 8 curtain panels

Size: 72"L x 12"W x 0.4" D 26 $21.00 $9.10

Squeeze Bottle with Wipe on 8 curtain panels

Size: 72"L x 12"W x 0.4" D 24 $21.00 $8.40

In-house manufacture of sterile IPA or EtOH:

The costs associates with the manufacture of sterile alcohol are identified as follows. It is important to include all costs that the company may incur to accurately identify the cost impact. Purchase Alcohol Receiving Inspection Formulation

Purchase Alcohol Receive Batch Formula Records Quarantine Formulations Area Sample Formulation Equipment Release Change Over Procedure Solvent Storage Sterile Records: Cert. of Analysis - Filter - Lines - Receiving Vessel - Sterile Receive Vessel Total = $ 4.00/gallon Total = $ 4.00/gallon Total = $ 10.00/gallon


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Sterilizing Components Create Sterilization Records for Components

Perform QA Testing Quarantine Product

Containers Sterility Particulate Matter 14 days Caps Particulate Matter Cert. of Analysis Labels Total = $ 5.00/gallon Total =$ 3.00/gallon Total = 6.00/gallon Total = $ 1.50/gallon Safety Storage Overhead Total Costs

Bagged Amortization of Equip. Shelf Life Records/ inventory Space Insurance Other

Total = $ 1.00/gallon Total = $ 14.00/gallon Grand Total $52.50/gallon For Non-Irradiated Product

Larger Volume Containers: At times, larger volumes of sterile IPA and EtOH are required. Typical containers include 1 gallon, 5 gallon or 55 gallon containers. When sterile alcohol is purchased in such large volume, the chance for contamination of the solution upon opening is increased. Some operations purchase these containers and pour to pre-sterilized bottles. Again handling may cause possible contaminants to enter the sterile system. However, if used appropriately, large volume containers are less expensive and better if larger volume is required at one time. Disposal of Emptied Containers: The aerosol, trigger spray and squeeze bottles are all made of 100% recyclable material. The aerosol is clean manufactured aluminum and the trigger spray and squeeze bottles made of high-density polyethylene. All products carry the appropriate recycle symbols. Disposal of containers as recycle materials is really very simple. What is confusing is whether remaining alcohol in the containers is considered hazardous materials. This issue is governed by local, state, and federal regulations and should be confirmed prior to disposal. Please contact Veltek Associates, Inc. and we can completely assist you with this endeavor.


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Proper Use of the Products

Which is better? IPA or EtOH?

Overall, IPA seems to be more effective on clean room organisms while EtOH more effective when addressing viruses. Addressing this subject requires the review of some extended testing analysis. One of the bests sources, available from VAI technical representatives is: Block, Seymour Stanton (ed.), Disinfection, Sterilization and Preservation, Lea and Febiger, 4th Edition, Philadelphia, 1991, Chapter 11, Alcohols, p. 191. Summarizing the data in this technical document would not do the testing justice and we suggest evaluating it’s content.

Using IPA and EtOH on surfaces: Some confuse the element of spraying a chemical agent to the surface as the same in disinfection as wiping a surface with a saturated wipe. They are not the same. Disinfection is based on the saturation and penetration of the cell wall over a specified contact or dry time. Simply, the longer the surface remains wetted, the better the efficacy performance of a chemical agent. However, the limitation to this rule is based on the chemical’s ability to destroy a cell in the populas that exists on the surface. Simply, spraying is always better than wiping with a saturated wipe as the contact or dry time is longer. Coverage of the entire surface is critically important and as discussed previously, the aerosol container provides the best and most repeatable coverage of the surface. However, to clean, one needs to wipe. But wiping has two options. One option is to spray an alcohol solution to the surface and then wipe with a dry wipe. The other option is to use a wetted or saturated wipe. Imagine we are cleaning a dirtied window in our home. If we used an alcohol saturated wipe to clean the surface we would probably remove very little from the surface and just move the contamination (dirt) around. If we sprayed the alcohol to the window of the surface and then wiped it with a dry wipe, we would remove more contamination from the surface. To clean the use of alcohol and a dry wiper is superior. While alcohol wipes do have their place, it may not be the most effective manner to clean. Veltek Associates, Inc. manufactures both alcohol sprays and saturated wipes and recommendations are based on what is most effective for each operation.


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Using IPA and EtOH on gloves: One of the most widely used methods for decontamination of gloves is IPA or EtOH. IPA is used by more organizations worldwide for this function as it has superior data against clean room organisms. When we evaluate that container to use in this capacity, we notice two areas where alcohol is needed.

1. Prior to entry (gowning area) 2. In manufacturing for gloves and surfaces

The first, prior to entry to the aseptic area (normally in gowning areas), is best done through a hands-free system. Several systems exist from Veltek Associates, Inc.

1. The Asepti-Cleanse Auto-eye Dispensing System 2. The DEC-100 Back of Hand Operated System 3. The DEC-100 Foot-Pedal Operated system

All three are pictured below:

Asepti-Cleanse Dispensing System DEC-50 DEC-100 The Asepti-Cleanse Dispensing system uses a 32-ounce sterile bag of DECON-AHOL, STER-AHOL, DECON-HAND, or DECON-SOAP. Like the aerosol container, the bag does not aspirate the room air to the master reservoir and remains sterile from first use till last use. Simplicity in operation is a feature of this unit as one just places their hands underneath and the photo-eye senses to dispense a predetermined level of liquid. For further information on this system, please refer to VAI technical document (ASP-CLS-01.PDF). The DEC-50 and DEC-100 also provide excellent dispensing of alcohol via the aerosol can. Again, the product is sterile from first use till last. For information on the DEC-50 and DEC-100, Please refer to technical document DISP-01.PDF.


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While dispensing systems are the best alternative, the user of one of the containers to dispense is also acceptable. Understanding that the gowning area is not aseptic is critical and the aspiration of room air to the master solution (suck back to the remaining alcohol) is more critical in this area as bioburden is higher. Thus, the aerosol remains the superior container in this sector as it can be used for a longer time period without removal. Another concern besides the sterility solution is the exterior of the container and handling by various personnel. This becomes more critical in the gowning area as bioburden is higher than within the aseptic area. Spraying one hand with the aerosol and then wiping down the can and praying the other hand is excellent aseptic techniques. This can also be done with the squeeze bottle. It assures that the container has been routinely saturated with the chemical and keeps the bottle with a lower bioburden. The trigger spray is much harder to assure exterior wetting as the trigger mechanism is very intricate and cannot be wetted by a saturated hand. Thus this container cannot be wetted unless done by spraying with another container. During manufacture or in the gowning area we need to also look at the costs associated with each container. Simply, how many pairs of gloves can we spray with each container? Below is the analysis of this cost issue: Item Disinfected

Container Type Time Period to Wet All Surfaces

Total Pairs of Gloves Done with Container

Cost / Container

Cost/Pair of Gloves at List Price

Gloves 11 oz. Aerosol 5 seconds 188 $12.25 $0.07 16 oz. Trigger Spray 10 Seconds 101 $12.00 $0.12 16 oz. Squeeze Bottle 9 Seconds 91 $16.00 $0.18 Simply, the aerosol with a wider and more efficient spray pattern covers the gloves with less waster than the trigger spray or squeeze bottle. Most times when using a trigger spray or squeeze bottle, most of the alcohol runs off the hands and falls to the floor. Safety Issues: Simply IPA and EtOH is flammable. Please consult VAI’s MSDS for complete details referencing the safety, use and storage of these chemicals. Some of the general concerns in safety are:

1. Product is Flammable 2. Do not store in sunlight or warmer temperatures (above 120oF) 3. Do not use near flames 4. Wear protective clothing and goggles 5. Watch vapor build up is using a lot of IPA at one time

Veltek Associates, Inc. TDR-9000 03/03

1039 West Bridge Street Phoenixville, PA 19460-4218 USA Tel: (610) 983-4949 Fax: (610) 983-9494 www.sterile.com

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The Veltek Associates, Inc. MSDS’s for the product identify all concerns and should be read in it’s entirety before using the product. Quality Issues Very few manufacturers, if any, treat the manufacture of sterile IPA as a GMP product. Veltek Associates, Inc. manufactures all IPA products under current cGMP’s in a Class 100 clean roo operation from beginning to end. Veltek Associates, Inc. welcomes and encourages customer audits of our manufacturing processes. The products are manufactured as presented on the following pages.

DECON-AHOL® Sterile WFI Formula

Manufacturing All DECON-AHOL® raw material components such as anhydrous IPA, cans, bottles, valves, etc are incoming inspected, per GMP standards, to internally written specification and released upon acceptance by the QA department. All VAI Chemical operations are EPA and FDA registered and follow cGMP’s All DECON-AHOL® Products are Manufactured in accordance with cGMP's All DECON-AHOL® Products are made with USP Isopropyl Alcohol and USP Water for Injection All DECON-AHOL® Containers Washed in WFI Prior to Filling All DECON-AHOL® Valves Washed in WFI Prior to Filling All DECON-AHOL® manufacturing areas (Class 100-Class 10,000) are monitored for particulate and microbials. All DECON-AHOL® Containers are cleaned after filling All DECON-AHOL® Sterile products are packaged in Class 100 environment into double bags and then the case contents are packaged into a third polyethylene case liner in the carton. All DECON-AHOL® packaging bags are Class 100 Certified Bags All DECON-AHOL® products are filtered through a pre-sterilized 0.2 um filter All filters are Bubble Point Tested Before and After All DECON-AHOL® Sterile packages are then sterilized through a validated gamma sterilization cycle as proven by both an AAMI validation and a 10-6 reduction of b. pumilus spores that were implemented into the sterilization load. All DECON-AHOL® products are released and shipped by VAI’s Document Control Department

Testing All DECON-AHOL® products are assayed to USP 26 Specifications for “Isopropyl Rubbing Alcohol” All DECON-AHOL® products are Lot Sterility Tested to USP 26 (14 Day) Lab testing included the completion of Bacteriostasis per USP 26 Lab testing included the completion of Fungistasis per USP 26 All DECON-AHOL® products are validated as Sterile to AAMI Guidelines All DECON-AHOL® products are validated as Sterile by 10-6 reduction of b. pumilus VAI’s Water for Injection System is tested to meet USP 26 criteria All DECON-AHOL® products are Lot LAL Tested and Released at <0.45 eu/ml. All DECON-AHOL® products have been validated for an expiration period of 3 years (via assay and sterility testing).


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STER-AHOL® Sterile WFI Formula

Manufacturing All STER-AHOL® raw material components such as ethanol, cans, bottles, valves, etc are incoming inspected, per GMP standards, to internally written specification and released upon acceptance by the QA department. All VAI Chemical operations are EPA and FDA registered and follow cGMP’s All STER-AHOL® Products are Manufactured in accordance with cGMP's All STER-AHOL® Products are made with USP Water for Injection All STER-AHOL® Containers Washed in WFI Prior to Filling All STER-AHOL® Valves Washed in WFI Prior to Filling All STER-AHOL® manufacturing areas (Class 100-Class 10,000) are monitored for particulate and microbials. All STER-AHOL® Containers are cleaned after filling All STER-AHOL® Sterile products are packaged in Class 100 environment into double bags and then the case contents are packaged into a third polyethylene case liner in the carton. All STER-AHOL® packaging bags are Class 100 Certified Bags All STER-AHOL® products are filtered through a pre-sterilized 0.2 um filter All filters are Bubble Point Tested Before and After All STER-AHOL® Sterile packages are then sterilized through a validated gamma sterilization cycle as proven by both an AAMI validation and a 10-6 reduction of b. pumilus spores that were implemented into the sterilization load. All STER-AHOL® products are released and shipped by VAI’s Document Control Department

Testing All STER-AHOL® products are assayed and delivered with the lot specific Certificate of Analysis All STER-AHOL® products are Lot Sterility Tested to USP 26 (14 Day) Lab testing included the completion of Bacteriostasis per USP 26 Lab testing included the completion of Fungistasis per USP 26 All STER-AHOL® products are validated as Sterile to AAMI Guidelines All STER-AHOL® products are validated as Sterile by 10-6 reduction of b. pumilus VAI’s Water for Injection System is tested to meet USP 26 criteria All STER-AHOL® products are Lot LAL Tested and Released at <0.45 eu/ml. All STER-AHOL® products have been validated for an expiration period of 3 years (via assay and steriliy testing).


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Conclusion: Veltek Associates, Inc. is focused on providing a quality product that consistently meets cGMP requirements. We appreciate you selection of our product and look forward to serving you for years to come. We hope this use and selection guide has been helpful and please feel free to contact us if we can ever be of any assistance.

Veltek Associates, Inc. 1039 West Bridge Street

Phoenixville, PA 19460-4218 USA Tel: (610) 983-4949 Fax: (610) 983-9494 www.sterile.com

Written by: Art Vellutato, Jr.

V.P. Technical Support Operations

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