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Low pH Phenolic Germicidal Detergent/Disinfectant Sterile Pharmaceutical Clean Room Formula DECON-CYCLE-dcy-01 Rev. 06 May 2013 Veltek Associates, Inc., 15 Lee Boulevard, Malvern, PA 19355-1234 USA T: 610.644.8335 F: 610.644.8336 www.sterile.com

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Low pH Phenolic Germicidal Detergent/DisinfectantSterile Pharmaceutical Clean Room Formula

DECON-CYCLE-dcy-01 Rev. 06 May 2013

Veltek Associates, Inc., 15 Lee Boulevard, Malvern, PA 19355-1234 USA T: 610.644.8335 F: 610.644.8336 www.sterile.com

O V E R V I E W DECON-CYCLE®

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Veltek Associates, Inc. 15 Lee Boulevard, Malvern, PA 19355-1234 T: 610-644-8335 F: 610-644-8336 www.sterile.com

DECON-CYCLE-dcy-01 Rev 06 May 2013

DECON-CYCLE Sterile Pharmaceutical Clean Room Formula

PRODUCT DESCRIPTION

DECON-CYCLE LOW pH Phenolic is a phosphate free, dilutable, hospital germicidal detergent/disinfectant and is recommended for use by pharmaceutical industry, biotechnology industry, medical device manufacturers, hospitals and health care institutions that are dedicated to controlling the hazards of cross contamination in their establishments. DECON-CYCLE's multi-phenolic formula is designed to clean, disinfect and deodorize any washable inanimate non porous surface in one easy step. When used as directed, DECON-CYCLE is strong enough to kill a broad spectrum of pathogenic bacteria, yet mild enough to have no harmful effect on the surface being disinfected.

DECON-CYCLE is filled by sterile filtration at 0.2 microns in GMP ISO 5 (Grade A/B, Class 100) and subsequently gamma radiated to a 10-6 SAL level. DECON-CYCLE is available sterile and non-sterile in variety of sizes. Each sterile container is double bag packaged and delivered each time with the lot specific Certificate of Analysis, Certificate of Sterility and Certificate of Irradiation. DECON-CYCLE is completely traceable and has been validated for sterility and shelf life.

DECON-CYCLE has efficacy performance which has been confirmed using A.O.A.C. protocol testing.

The SimpleMIX® System Technology Alternative:

Veltek Associates, Inc. has developed the SimpleMIX System Technology to eliminate measuring and additional containers. It provides for the transfer of the sterile concentrate and sterile water in a sealed container to the aseptic area. The system container is double bag packaged for easy transfer and eliminates all internal and external sterility concerns. It assures use of a sterile, disinfectant or sporicide. The Patent Pending SimpleMIX System Gallon and 16oz Systems provide a sealed multi-chamber container that when activated mixes the solution to the use dilution. The opening on the top of the gallon size contains the concentrate and the bottom reservoir contains the USP WFI Quality Water. The 16 ounce side container houses the concentrate and the bottom reservoir houses the USP WFI Quality Water. Just open the small chamber cap, push the plunger container completely down until the bottom pops open and the bellows are compressed. The solution and water mix together. The system design permits the easy transfer of the product to the aseptic manufacturing area without concern for the transfer of contamination. See VAI Technical Document (SMix-01)

Uses: For use on hard, nonporous, inanimate surfaces in aseptic filling and gowning rooms, general manufacturing areas, or on machinery, tables, counters, laminar flow benches, floors, walls, stainless steel, porcelain, glass and chrome.

ORDERING INFORMATION Order# Description Quan/cs. DCY-01 DECON-CYCLE 1 Gallon Non-Sterile 4 DCY-02 DECON-CYCLE 1 Gallon Sterile 4 DCY-03-1Z DECON-CYCLE 1 oz. Sterile 24 DCY-03-2Z DECON-CYCLE 2 oz. Sterile 24 DCY-03-4Z DECON-CYCLE 4 oz. Sterile 24 DCY-04-1/2Z DECON-CYCLE SimpleMix Sterile 1 gallon 4 DCY-04-1Z DECON-CYCLE SimpleMix Sterile 1 gallon 4 DCY-05-1/2Z DECON-CYCLE SimpleMix Non-Sterile 1 gallon 4 DCY-06-16Z-01 DECON-CYCLE SimpleMix Sterile 0.0625/16oz 12 DCY-06-16Z-02 DECON-CYCLE SimpleMix Sterile 0.125/16oz 12 DCY-07-16Z-01 DECON-CYCLE SimpleMix Non-Sterile 0.0625/16oz 12 DCY-07-16Z-02 DECON-CYCLE SimpleMix Non-Sterile 0.125/16oz 12 DCY-10-200L-CI DECON-CYCLE SimpleMix Sterile 200 Liter 1

Available Technical Data Supplements (Upon Request) SC-001: Sterile Chemical Product Guide VL-501: DECON-CYCLE Technical Data Report

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DECON-CYCLE-dcy-01 Rev 06 May 2013

DECON-CYCLE

Sterile Pharmaceutical Clean Room Formula Low pH Phenolic Germicidal Detergent

PRODUCT LABELING

Any Specific Product Label Is Available Upon Request

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Presented from the Master Label dated 15 December 2010.

DECON-CYCLE

Sterile Pharmaceutical Clean Room Formula

Low pH Phenolic Germicidal Detergent Effective In Hard Water

up to 400 Ppm (Calculated as CaCO3) With Organic Soil Tolerance

Tuberculocidal - Germicidal - Pseudomonacidal Fungicidal – Virucidal (kills HIV-1) Bactericidal

Formulated for Effective Aseptic Controlled Environment (Clean Room) Sanitation

ACTIVE INGREDIENTS: Ortho-Phenylphenol.......................................................................................8.209% Orthobenzyl-para-Chlorophenol ....................................................................6.650% INERT INGREDIENTS...............................................................................85.141% Total ...............................................................................................................100.00%

Keep Out of Reach of Children

DANGER

Product and container sterilized and distributed by: Veltek Associates, Inc. (EPA Reg. No. 211-62-68959) (Veltek Sub-registration number)

15 Lee Boulevard (EPA Est. No. 68959-PA-1) (Veltek Sub-registration EPA number) Malvern, PA 19355-1234 Tel: (610)644-8335

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DANGER FIRST AID

If in eyes – Hold eye open and rinse slowly and gently with water for 15-20 minutes. – Remove contact lens, if present, after the first 5 minutes, then continue rinsing. – Call a poison control center or doctor for further treatment advice.

If on skin or clothing

– Take off contaminated clothing. – Rinse skin immediately with plenty of water for 15-20 minutes. – Call a poison control center or doctor for further treatment advice.

In inhaled – Move person to fresh air. – If person is not breathing, call 911 or an ambulance, then give artificial respiration,

preferably by mouth-mouth, if possible. – Call a poison control center or doctor for further treatment advice.

If swallowed – Call a poison control center or doctor immediately for treatment advice. – Have person sip a glass of water if able to swallow. – Do not induce vomiting unless told to do so by a poison control center or doctor. – Do not give anything by mouth to an unconscious person.

HOTLINE NUMBER In case of emergency, call your local poison control center or a doctor.

Have the product container or label with you when calling a poison control center or doctor or going in for treatment.

NOTE TO PHYSICIAN Probable mucosal damage may contraindicate the use of gastric lavage. Measures against circulatory shock, respiratory depression, and convulsion may be needed.

PRECAUTIONARY STATEMENTS Hazards to Humans and Domestic Animals

Corrosive. Causes irreversible eye damage or skin burns. Harmful if swallowed or absorbed through skin or inhaled. Do not get in eyes, on skin, or on clothing. Avoid breathing spray mist. Wear goggles or face shield. Wear protective clothing (long sleeve shirt and long pants, socks, plus shoed and chemical resistant gloves such as water proof gloves). Wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove contaminated clothing and was before reuse.

USER SAFETY REQUIREMENTS Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Users MUST remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly ad change into clean clothing. Users should remove clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.

PERSONAL PROTECTIVE EQUIPMENT (PPE)

Handlers must wear: Coveralls over long-sleeved shirt and long pants; socks and chemical resistant shoes; goggles or face shield and chemical resistant gloves (such as barrier laminate, butyl rubber, nitrile rubber, neoprene rubber, polyvinyl chloride, or vition). Follow manufacturer’s instructions for cleaning/maintaining Personal Protective Equipment (PPE). If no such instructions exist, use detergent and hot water. Keep and wash PPE separately from other laundry.

ENVIRONMENTAL HAZARDS This product is toxic to fish and aquatic organism. Do not discharge effluents containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your State Water Board or Regional Office of the EPA.

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STORAGE AND DISPOSAL Do not contaminate water, food, or feed by storage or disposal.

PESTICIDE STORAGE – Store in a securely closed original container. Store in area that will prevent cross contamination of other pesticides, fertilizer, food, or feed. Avoid storage at temperature extremes or in sunlight. PESTICIDE DISPOSAL – Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste representative at the nearest EPA Regional Office for guidance. CONTAINER DISPOSAL - Nonrefillable container. Do not reuse or refill this container. Offer for recycling, if available or Offer for reconditioning if appropriate or Puncture and dispose of in a sanitary landfill, or by incineration. Less than or equal to 5 gallons: Clean container promptly after emptying or Triple rinse container (or equivalent) promptly after emptying. Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank and drain for 10 seconds after the flow begins to drip. Fill the container ¼ full with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix tank or store rinsate for later use or disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times.

Greater than 5 gallons: Clean container promptly after emptying or triple rinse container (or equivalent) promptly after emptying. Triple rinse as follows: Empty the remaining contents into application equipment or a mix tank. Fill the container ¼ full with water. Replace and tighten closures. Tip container on its side and roll it back and forth, ensuring a least one complete revolution, for 30 seconds. Stand the container on its end and tip it back and forth several times. Empty the rinsate into application equipment or a mix tank and store rinsate for later use or disposal. Repeat this procedure two more times.

DIRECTIONS FOR USE It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

CLEANING AND DISINFECTION For broad spectrum disinfection of gram negative (as demonstrated by efficacy against Salmonella enterica) and gram positive (as demonstrated by efficacy against Staphylococcus aureus and Pseudomonas aeruginosa) bacteria, add ½ ounce DECON-CYCLE per 1 gallon of water. Remove heavy soil or gross filth then apply solution with a mop, cloth, sponge, or hand-pump trigger sprayer so as to wet surface thoroughly. Allow to remain wet for 10 minutes and then air dry. If higher detergency is desired, increase to 1 ounce per gallon of water.

**Medical Device Uses DECON-CYCLE is a general purpose disinfectant that may be used to clean and disinfect hard, non-porous, inanimate, non-critical medical and dental equipment surfaces. DECON-CYCLE may also be used to clean and/or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection.

This product is not to used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used to preclean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection.

To clean and disinfect toilet bowls and urinal surfaces, remove gross soils from surfaces with bowl brush and flush toilet or urinal prior to applying the use solution. Remove residual bowl water from toilet and urinal by forcing water over the trap with a bowl swab. Press bowl swab against side of the bowl or urinal to remove excess water from the applicator. Add ½ ounce of DECON-CYCLE directly into the bowl or urinal trap water. Swab or brush the interior surface of the fixture thoroughly, making sure to get under the rim. For disinfection, allow to stand for 10 minutes then flush. Wipe exterior surfaces with a cloth or sponge.

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EFFICACY PERFORMANCE

The broad spectrum efficacy of DECON-CYCLE has been confirmed using A.O.A.C. protocol testing at a use-dilution of 1:256 in hard water up to 400 ppm (calculated as CaCO3) in the presence of 5% blood serum (used to simulate organic soil load), at 200C with an exposure time of 10 minutes.

GERMICIDAL: DECON-CYCLE is effective against a broad spectrum of Gram positive and Gram negative pathogens as confirmed by the A.O.A.C. Use-Dilution test, in hard water up to 400 ppm (calculated as CaCO3 and in the presence of 5% organic soil load at 200C with an exposure time of 10 minutes against the following organisms: Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Methicillin Resistant Staphylococcus aureus (MRSA).

FUNGICIDAL: DECON-CYCLE is effective against the following pathogenic fungi, as confirmed by A.O.A.C. Use-Dilution test, in hard water up to 400 ppm (calculated at CaCO3), and in the presence of 5% organic soil load at 200C with an exposure time of 10 minutes, in use areas such as shower room floors, locker room benches, bathmats, or any other head nonporous, inanimate environmental surfaces: Trichophyton mentagrophytes (the athlete’s foot fungus). TUBERCULOCIDAL: DECON-CYCLE is effective against Mycobacterium bovis (BCG) as demonstrated through testing using the A.O.A.C. Method “Confirmative in Vitro Test for Determining Tuberculocidal Activity”, in hard water up to 400ppm (calculated as CaCO3) and in the presence of 5% organic soil load, at 200 C with an exposure time of 10 minutes. VIRUCIDAL: DECON-CYCLE is effective against the following viruses on hard, nonporous, inanimate surfaces, as confirmed by the A.O.A.C. Use-Dilution test, in hard water up to 400 ppm (calculated at CaCO3) and in the presence of 5% organic soil load, at 200C with an exposure time of 10 minutes: HIV-1 (AIDS virus), Vaccina Virus, Herpes Simplex virus Type 2 (HSV-2), Influenza virus type A2.

Respiratory illnesses attributable to Pandemic 2009 H1N1 are caused by influenza A virus. DECON-CYCLE is a broad-spectrum hard surface disinfectant that has been shown to be effective against (influenza A virus tested and listed on the label) and is expected to inactivate all influenza A viruses including Pandemic H1N1 (formerly called swine flu.) This product has demonstrated effectiveness against influenza A virus and is expected to inactivate all influenza A viruses including Pandemic 2009 H1N1 influenza A virus.

KILLS HIV-1 ON PRE-CLEANED ENVIRONMENTAL SURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/BODY FLUIDS in health care settings or other settings in which there is an expected likelihood of soiling of inanimate surfaces/objects with blood or body fluids, and in which the surfaces/objects likely to be soiled with blood or body fluids can be associated with the potential for transmission of human immunodeficiency virus Type -1 (HIV-1) (associated with AIDS). SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HIV-1 (AIDS VIRUS) OF SURFACES/OBJECTS SOILED WITH BLOOD/BODY FLUIDS. PERSONAL PROTECTION: Clean-up should always be done wearing protective latex gloves, gowns, masks and eye protection. CLEANING PROCEDURE: Blood and other body fluids must be thoroughly cleaned from surfaces and objects before application of the disinfectant. CONTACT TIME: Leave surface wet for 10 minutes with a ½ ounce per gallon use-dilution (1:256), DECON-CYCLE and water. DISPOSAL OF INFECTIOUS MATERIALS: Blood, body fluids, cleaning materials and clothing should be autoclaved and disposed according to local regulations for infectious waster disposal.

PELIGRO: Si no puede leer in ingles, pregunte a su supervisor sobre las instrucciones do uso apropiadas antes do trabajar con este producto.

Formulated for Effective Hospital and Health Care Facility Sanitation.

DECON-CYCLE is a phosphate-free, dilutable, hospital germicidal-detergent effective in 10 minutes at 200C, in hard water up to 400 ppm (calculated as CaCO3), in the presence of 5% blood serum, used to simulate organic soil. DECON-CYCLE’s multi-phenolic formula is designed to clean, disinfect, and deodorize any washable, inanimate, non-porous surface in one easy step. When used as directed, DECON-CYCLE is strong enough to kill a broad

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spectrum of pathogenic bacteria, yet it is mild enough to have no harmful effects on the surface being disinfected, when used as directed.

DECON-CYCLE has been formulated for use on hard, inanimate surfaces commonly found in facilities and areas such as: hospitals, nursing homes, other health care institutions, and establishments that are dedicated to controlling the hazards of cross contamination. This product is specifically designed for use in hospitals, hospital emergency departments, ambulance and patient transfer vehicles, police and law enforcement vehicles, prisoner holding areas, office, funeral homes, restrooms, medical and dental offices, and day car facilities.

DECON-CYCLE is recommended for use on hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, hampers, telephones, clean up carts, bassinets, dressing carts, toilet bowl surfaces, urinal surfaces, showers, bathtubs, bed frames, mattress springs, impervious vinyl surfaces, counter tops, table tops, sinks, waste containers, lockers desks, patient transfer lifts, patient scales, examination tables, dental chairs, medical lamps, stethoscopes, bedpans, blood donor chairs, crutches, instrument trays, operating tables, and other hard, non-porous surfaces that need disinfection.

DECON-CYCLE is a dilutable germicidal detergent formulated for use where broad spectrum disinfection is required in the presence of moderate amounts of organic soil, in hard water up to 400 ppm (calculated as CaCO3).

DECON-CYCLE is effective for immersion disinfection of inanimate, non-porous surfaces. Use at a dilution of 1:256 (1/8 ounces per 32 ounces of water, or 4mL per liter).

DISINFECTION: Thoroughly clean and rinse instruments before immersion in disinfection solution. Immerse instruments completely for 10 minutes at room temperature (200c/680F). After immersion, remove instruments and rinse them thoroughly. Fresh solution should be prepared daily or more often if solution becomes visibly dirty.

CONFIRMATION: When tested with full immersion at room temperature for 10 minutes in a solution created as above, DECON-CYCLE was confirmed effective against Mycobacterium tuberculosis, Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella enterica, Trichophyton mentagraophytes, Staphylococcus aureus (methicillin resistant strain), Escherichia coli, and Herpes simplex type 2 on hard, nonporous surfaces.

DECON-CYCLE is a dilutable germicidal detergent formulated to clean, disinfect, and deodorize any washable, inanimate non-porous instrument or surface in one easy step. When used as directed, it is strong enough to kill a broad spectrum of pathogenic bacteria, yet mild enough to have no harmful effects on the surface being disinfected. DECON-CYCLE inhibits mold and mildew, and has a pleasant lavender fragrance.

DECON-CYCLE is acceptable for use by pharmaceutical and biotechnology industries; medical device manufacturers; hospitals and any health care institutions that are dedicated to controlling the hazards of cross contamination in their establishments. For use on hard, inanimate surfaces in aseptic filling and gowning rooms, general manufacturing areas, or on machinery, tables, counters, laminar flow benches, floors, walls, stainless steel, glazed porcelain, glass or chrome.

FUNGICIDAL: At ½ ounce per gallon of water, DECON-CYCLE is also effective against Trichophyton mentagrophytes pathogenic fungi in use areas as aseptic filling and gowning rooms, and general manufacturing areas or on any other hard, non-porous, inanimate environmental surfaces.

VIRUCIDAL DECON-CYCLE is effective against the following viruses as confirmed by A.O.A.C. use-dilution test, in hard water up to 400 ppm (calculated at CaCO3) and in the presence of 5% organic soil load, at 200C with an exposure time of 10 minutes: Canine Parvo Virus, Feline Parvo Virus.

Formulated for Effective Instrument Cleaning and Decontamination Sanitation. Formulated for Effective Aseptic Controlled Environment (“Clean Room”) Sanitation.

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DECON-CYCLE Sterile Pharmaceutical Clean Room Formula

Low pH Phenolic Germicidal Detergent

Testing Results Summary

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Efficacy Testing Results Summary This product is bactericidal according to the AOAC Use Dilution Test Germicidal Spray Method in the presence of 5% organic soil on hard inanimate surfaces when not more than 1 out of 60 carriers are positive for growth. (Total carriers = 540.)

Organism Carrier Population Sample Lot (All >60 days old)

# Carriers # Positive

Pseudomonas aeruginosa ATCC #15442

2.7 x 10^5 CFU/Carrier A 60 0/60 4.9 x 10^5 CFU/Carrier B 60 0/60 5.5 x 10^5 CFU/Carrier C 60 1/60

Salmonella enterica (choleraesuis) ATCC # 10708

6.1 x 10^5 CFU/Carrier A 60 1/60 4.1 x 10^6 CFU/Carrier B 60 1/60 7.6 x 10^5 CFU/Carrier C 60 1/60

Staphylococcus aureus ATCC #6538

2.1 x 10^6 CFU/Carrier A 60 1/60 4.1 x 10^6 CFU/Carrier B 60 0/60 1.2 x 10^6 CFU/Carrier C 60 1/60

Supplemental Organisms (Testing is performed per the AOAC UDT/GST method. Ten carriers are required on 2 separate lots against each supplemental organism. Killing of 10 out of 10 carriers.)

Organism Carrier Population Sample # Carriers # Positive

Bacillus subtilis ATCC # 19659 1.6 x 10^6 CFU/Carrier A 10 0/10 B 10 0/10

Escherichia coli ATCC # 11229 2.6 x 107 CFU/Carrier A 20 0/10 1.0 x 107 CFU/Carrier B 20 0/10

Staphylococcus aureus (Methicillin Resistant) ATCC #

33592

1.5 x 10^5 CFU/Carrier A 10 0/10

1.5 x 10^6 CFU/Carrier B 10 0/10

Other Supplemental Tests Testing is performed per the AOAC UDT/GST method. Ten carriers were done per lot, except HIV below is individual test on each of two lots.

Organism Carrier Population Sample # Carriers # Positive Mycobacterium bovis (BCG)

EPA-BARC 4.96 x 10^5 CFU/Carrier D 10 0/10

Mycobacterium bovis (BCG) EPA-BARC

4.96 x 10^6 CFU/Carrier E 10 0/10

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Virucidal Testing This product was evaluated in the presence of 5% serum with a 10 minute contact time and found to be effective against the following viruses on hard nonporous environmental surfaces. (Testing is performed per EPA Guidance (DIS/TSS-7). Two separate lots are tested. Inactivation of virus must be demonstrated when no cytotoxicity is observed or above the cytotoxic level when it is observed. The data must demonstrate a 4-log reduction in viral titer for both lots.)

Organism Dried Virus Control Sample Result Log Reduction Vaccina virus WR strain ATCC VR-

119 6.25 Log10

A ≤0.5 Log10 ≥5.75 Log10 B ≤0.5 Log10 ≥5.75 Log10

Herpes Simplex Type 2 ATCC VR-734 Strain G

5.5 Log10 A ≤0.5 Log10 ≥5.0 Log10 B ≤0.5 Log10 ≥5.0 Log10

Human Immunodeficiency Virus type 1 (HIV 1) HTLV-IIIB

6.0 Log10 A ≤1.5 Log10 ≥4.5 Log10 B ≤1.5 Log10 ≥4.5 Log10

Infectious Laryngotracheitis Virus (LT) Strain LT-IVAX

4.75 Log10 C ≤0.5 Log10 ≥4.25 Log10 D ≤0.5 Log10 ≥4.25 Log10

Influenza A2 Virus ATCC VR-5441 5.25 Log10 A ≤0.5 Log10 ≥4.75 Log10 B ≤0.5 Log10 ≥4.75 Log10

Foot & Mouth Disease OBFS-18600 (UK)

6.38 Log10 A ≤1.5 Log10 ≥4.5 Log10 6.47 Log10 B ≤1.5 Log10 ≥4.5 Log10

Infectious Bursal Disease Virus (IBR) ATCC VR-2041

6.0 Log10 A ≤1.5 Log10 ≥4.5 Log10 B ≤1.5 Log10 ≥4.5 Log10

Fungicidal Testing (Testing is performed per the AOAC UDT/GST method. Ten carriers are required on 2 separate lots against each supplemental organism. Killing of 10 out of 10 is required.)

Organism Carrier Population Sample # Carriers # Positive Trichophyton mentagrophytes

ATCC 9533 2.8 x 106 CFU/Carrier B 10 0/10

1.3 x 10^5 CFU/Carrier C 10 0/10 Aspergillus fumigatus ATCC

6285 1.04 x 108 CFU/Carrier A 10 0/10

1 Please contact VAI for exact Master Label Testing Statement.

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DECON-CYCLE

Sterile Pharmaceutical Clean Room Formula Low pH Phenolic Germicidal Detergent

Lot Specific

Sterile Documentation (received with each shipment)

Certificate of Analysis Certificate of Sterility

Certificate of Irradiation

(Please contact VAI for a sample of this documentation)