low ph, phosphate free, phenolicdec-cycle rev 19jan2016 ml rev: d-15 product description dec-cycle...

DEC-CYCLE® Low pH, phosphate free, Phenolic

Sterile pharmaceutical cleanroom formula

DEC-CYCLE® Technical Data File

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

DEC-CYCLE Rev 19Jan2016 ML Rev: D-15

Product Description

DEC-CYCLE low pH phenolic is a phosphate free, dilutable, hospital germicidal detergent/disinfectant and is recommended for use by the pharmaceutical industry, the biotechnology industry, medical device manufacturers, hospitals, and health care institutions that are dedicated to controlling the hazards of cross contamination in their establishments. DEC-CYCLE's multi-phenolic formula is designed to clean, disinfect and deodorize any washable inanimate, environmental, non-porous surface. When used as directed, DEC-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. DEC-CYCLE has efficacy performance that has been confirmed using efficacy testing approved by the US EPA. DEC-CYCLE is filled by sterile filtration at 0.2 microns in an ISO 5 (Grade A/B, former Class 100) operation and subsequently gamma irradiated to a 10-6 SAL. DEC-CYCLE is available sterile and non-sterile in variety of sizes. Each sterile container is double bag packaged, available in the ABCD introduction system, and delivered each time with the lot specific Certificate of Analysis, Certificate of Sterility and Certificate of Irradiation. DEC-CYCLE is completely traceable and has been validated for sterility and shelf life.

Quality and Manufacturing • Gamma irradiated at a 10-6 SAL • Each container is double packaged sterile • Completely lot traceable and has been validated for sterility and shelf life • Filtered at 0.2 microns in an ISO 5 operation • Delivered each time with lot specific documentation and safety material • Sterility tested according to current USP Compendium

Features and Benefits • Available in the ABCD Introduction System TM • Available in our patented SimpleMix System • Multiple convenient container sizes – Unit Dose, 16oz, 1 Gallon, and 200L • Clean, disinfects, and deodorizes • Has a broad spectrum efficacy for multiple organisms • Mild enough to have no harmful effects on the surface being disinfected when used as directed • Formulated for effective hospital and health care facility sanitation • Available in sterile or non-sterile versions

DEC-CYCLE – Low pH, Phosphate Free, Phenolic

Certificate of Analysis Result Appearance: Clear Amber Solution

Odor: Mild Phenolic/Alcohol

pH, Concentrate: 1.50-2.50

Specific Gravity: 1.082-1.102

Expiration Period 2 years




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

The SimpleMix® System Technology Alternative Veltek Associates, Inc. has developed the patented SimpleMix System Technology to eliminate measuring and additional containers. It provides for the transfer of the sterile concentrated disinfectant or sporicide 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. The patented SimpleMix System Gallon, 16oz, and 200L systems provide a sealed multi-chamber container that when activated mixes the solution to the correct use dilution. The opening on the top of the gallon size contains the concentrate and the bottom reservoir contains the VAI WFI Quality Water. The 16 ounce side container houses the concentrate and the bottom reservoir houses the VAI 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. 200L SimpleMix systems are activated through a hose and valve system connecting the cubicontainer of concentrate to the VAI WFI Quality Water. 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.

ABCD Cleanroom Introduction System TM The ABCD Cleanroom Introduction System is a packaging system that allows operators/users to take the package through each level of classified areas by simply removing one bag at a time. Each bag acts as barrier protecting the finished product from becoming a carrier of viable and non-viable contamination. This prevents the need to decontaminate each outer bag prior to entering a cleaner area. In this packaging system, sterilized groups of containers are contained in two outer bags and after each are removed individual containers are each additionally contained in two easy tear bags.




Ordering Information

DEC-CYCLE – Low pH Phenolic Germicidal Detergent

Part number Description Qty/cs DCY-01-E DEC-CYCLE, 1 Gallon, Concentrate, Non-Sterile 4

DCY-02-E DEC-CYCLE, 1 Gallon, Concentrate, Sterile 4

DCY-03-1Z-E DEC-CYCLE, 1 oz , Unit Dose, Sterile 24



DCY-04-1/2Z-E DEC-CYCLE, 1 Gallon, SimpleMix, 1:256, Sterile 4

DCY-04-1Z-E DEC-CYCLE, 1 Gallon, SimpleMix, 1:128, Sterile 4

DCY-05-1/2Z-E DEC-CYCLE, 1 Gallon, SimpleMix, 1:256, Non-Sterile 4

DCY-05-1Z-E DEC-CYCLE, 1 Gallon, SimpleMix, 1:128, Non-Sterile 4

DCY-06-16Z-01-E DEC-CYCLE, 16 oz, SimpleMix, Trigger Spray, 1:256, Sterile 12

DCY-06-16Z-02-E DEC-CYCLE, 16 oz, SimpleMix, Trigger Spray, 1:128, Sterile 12

DCY-07-16Z-01-E DEC-CYCLE, 16 oz, SimpleMix, Trigger Spray, 1:256, Non-Sterile 12

DCY-07-16Z-02-E DEC-CYCLE, 16 oz, SimpleMix, Trigger Spray, 1:128, Non-Sterile 12

DCY-10-200L-CI-E DEC-CYCLE, 200L, SimpleMix Drum 1




VAI’s Product Label Colors:




PRODUCT LABELING

Any Specific Product Label Is Available Upon Request

DEC-CYCLE

Sterile Pharmaceutical Cleanroom Formula

Low pH Phenolic 256 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 (Cleanroom) Sanitation Sterile pharmaceutical cleanroom formula

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




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. CHARECHEM 24 Spill/Exposure Emergency 866-928-0789.

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.




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: 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. For non-refillable SimpleMix® Drums and Containers Non-Refillable Container. Triple rinse container promptly after emptying by running pump to dispense all product left in the system into application equipment. Cubic Container: Disconnect cubic container hose at valve 1. Fill the container ¼ full with water and recap. Shake for 10 seconds. Follow pesticide disposable instructions for rinsate disposal. Drain for 10 seconds after the flow begins to drip. Repeat this procedure two more times. Then offer for recycling if available or puncture and dispose of in a sanitary landfill, or by incineration. 200L Drum: Fill the drum ¼ full with water. Close all tubing valves. Tip container on its side and roll it back and forth, ensuring at least one complete revolution for 30 seconds. Stand the container up and tip it back and forth several times. Empty rinsate into appropriate storage vessel for disposal. Repeat this procedure two more times. Follow Pesticide Disposal for rinsate disposal. Then offer for recycling if available or puncture and dispose of in a sanitary landfill, or by incineration.




Efficacy Performance

The broad spectrum efficacy of DEC-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: DEC-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: DEC-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). At ½ ounce per gallon of water, DEC-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. TUBERCULOCIDAL: DEC-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: DEC-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. DEC-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.

Respiratory illnesses attributable to Pandemic 2009 H1N1 are caused by influenza A virus. DEC-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.)

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), DEC-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 waste disposal.




DEC-CYCLE Statements Sterile Pharmaceutical Cleanroom Formula

Formulated for effective hospital, health care facility, aseptic controlled environment (cleanroom), and instrument cleaning and decontamination sanitation. DEC-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. DEC-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, DEC-CYCLE is strong enough to kill a broad spectrum of pathogenic bacteria, yet it is mild enough to have no harmful effects on the surface being disinfected, when used as directed. DEC-CYCLE has been formulated for use on hard, nonporous, 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. DEC-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). DEC-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). **Medical Device Uses DEC-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. DEC-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 be 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. DEC-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. DEC-CYCLE inhibits mold and mildew, and has a pleasant lavender fragrance. DEC-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. PELIGRO: Si no puede leer in ingles, pregunte a su supervisor sobre las instrucciones de su uso apropiadas antes do trabajar con este producto.




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 Pseudomonas aeruginosa) and gram positive (as demonstrated by efficacy against Staphylococcus aureus) bacteria, add ½ ounce DEC-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. This product may be applied only by the methods specified on the labeling. 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, DEC-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.

SimpleMix System Technology

SimpleMix® is a convenient closed system that delivers an accurate use solution of pre-measured disinfectant concentrate and water every time equivalent to 580 ppm active without measuring. DIRECTIONS FOR USE PREPARATION OF DISINFECTION USE SOLUTION: For heavily soiled areas in non-medical premise, a preliminary cleaning is required. Mix 1 ounce of DEC-CYCLE per 2 gallons of water to disinfect hard non-porous, inanimate, environmental, surfaces. Apply use solution using a brush, sponge, cloth, mop, auto scrubber, mechanical spray device, or by immersion so as to thoroughly wet surfaces. For sprayer applications spray 6-8 inches from surface. Do not breathe spray. Rub with brush, cloth, or sponge. Treated surfaces must remain wet for 10 minutes. Allow to air dry or rinse. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled. PREPARATION OF DISINFECTION/VIRUCIDAL*/FUGICIDAL USE SOLUTION: For heavily soiled areas, a preliminary cleaning is required. Mix 1 ounce of DEC-CYCLE per 2 gallons of water to disinfect hard non-porous, inanimate, environmental surfaces. Apply use solution using a brush, sponge, cloth, mop, auto scrubber, mechanical spray device or by immersion so as to thoroughly wet surfaces. For sprayer applications spray 6-8 inches from surface. Do not breathe spray. Rub with brush, cloth, or sponge. Treated surfaces must remain wet for 10 minutes. Allow to air dry or rinse. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled. CLEANING AND DISINFECTION: For heavily soiled areas in non-medical premise, a pre-cleaning step is required. For one-step cleaning and general disinfection. Mix 1 ounce of DEC-CYCLE per 2 gallons of water use solution. Apply use solution using a brush, sponge, cloth, mop, auto scrubber, mechanical spray device or by immersion so as to thoroughly wet surfaces. For sprayer applications spray 6-8 inches from surface. Do not breathe spray. Rub with brush, cloth, or sponge. Treated surfaces must remain wet for 10 minutes. Allow to air dry or rinse. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled.




TO DEODORIZE: For heavily soiled areas, a preliminary cleaning is required. Mix 1 ounce of DEC-CYCLE per 2 gallons of water use solution. Apply use solution using a brush, sponge, cloth, mop, auto scrubber, mechanical spray device or by immersion so as to thoroughly wet surfaces. For sprayer applications spray 6-8 inches from surface. INSTITUTIONAL DISINFECTANT DIRECTIONS (HOSPITALS, DENTAL OFFICES, NURSING HOMES, AND OTHER HEALTH CARE INSTITUTIONS): For heavily soiled areas, a preliminary cleaning is required. For disinfecting hard, non-porous, inanimate, environmental surfaces such as floors, walls, countertops, bathing areas, lavatories, bed frames, tables, chairs, garbage pails mix 1 ounce of DEC-CYCLE with 2 gallons of water to disinfect, hard, non-porous, inanimate, environmental surfaces. Apply use solution to surfaces, thoroughly wetting surfaces with a brush, cloth, mop, sponge, auto scrubber, mechanical spray device or by immersion. For sprayer applications, spray 6-8 inches from surface. Do not breathe spray. Rub with brush, cloth, or sponge. Treated surfaces must remain wet for 10 minutes. Allow to air dry or rinse. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled. ANIMAL LIFE SCIENCE LABORATORY: For cleaning and disinfecting hard, non-porous, inanimate, environmental, surfaces in an Animal Life Science Laboratory such as equipment, utensils, instruments, cages, kennels, stables, stalls and catteries, apply a use solution of 1 oz DEC-CYCLE per 2 gallons of water and apply so as to wet thoroughly. Apply use solution using a brush, sponge, cloth, mop, auto scrubber, mechanical spray device or by immersion. For spray applications, spray 6-8 inches from surface. Do not breathe spray. Rub with brush, cloth, or sponge. Allow surface to remain wet for a period of 10 minutes. Immerse all halters and other types of hard, non-porous, inanimate, environmental, equipment used in handling and restraining animals as well as forks, shovels, scrapers used in removing litter and manure in the use solution. Ventilate buildings and other closed spaces. Do not house animals or employ equipment until treatment has been absorbed, set or dried. Thoroughly scrub all treated feed racks, automatic feeders, waterers and other treated equipment that dispenses food or water with soap or detergent, and rinse with potable water before reuse. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled. SPECIAL INSTRUCTIONS FOR INACTIVATING AVIAN INFLUENZA A (H5N1) VIRUS: Apply 1 oz of DEC-CYCLE per 2 gallons of water and apply to all hard nonporous, inanimate, environmental surfaces and allow to remain wet for a period of 10 minutes. Apply by cloth, mop, brush, sponge, auto scrubber, mechanical spray device or by immersion. For spray applications, spray 6-8 inches from surface. Do not breathe spray. Immerse all halters and other types of hard non-porous, inanimate, environmental equipment used in handling and restraining animals as well as forks, shovels, and scrapers used in removing litter and manure. Ventilate buildings, coops, and other closed spaces. Do not house poultry or employ equipment until treatment has been absorbed, set, or dried. Thoroughly scrub treated feed racks, troughs, automatic feeders, fountains, and waterers, and other treated equipment with soap or detergent, and rinse with potable water before reuse. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled. FUNGICIDAL ACTIVITY: At 1 ounce of DEC-CYCLE per 2 gallons use-level is effective against Trichophyton mentagrophytes on hard nonporous, inanimate, environmental surfaces in the presence of 5% blood serum in locker rooms, dressing rooms, shower and bath areas and exercise facilities. Apply use solution using a brush, sponge, cloth, mop, auto scrubber, mechanical spray device or by immersion so as to thoroughly wet surfaces. For sprayer applications spray 6-8 inches from surface. Do not breathe spray. Saturate surfaces with use solution. Treated surfaces must remain wet for 10 minutes. Allow solution to dry on surface and repeat treatment every seven days or when new growth appears. Change cloth, sponge or towels frequently to avoid redeposition of soil. A fresh solution must be prepared at least daily or when use solution becomes visibly soiled. MOLD AND MILDEW CONTROL DIRECTIONS: At 1 ounce per 2 gallons use-level, DEC-CYCLE will effectively inhibit the growth of mold and mildew and the odors caused by them when applied to hard, non-porous, inanimate, environmental surfaces as indicated in general instructions above.




DIRECTIONS FOR ALTERNATE CONTAINERS/DELIVERY SYSTEMS. AUTOMATED DILUTION SYSTEM, SIMPLE-MIX INSTRUCTIONS: SIMPLEMIX® SYSTEM CONTAINER: Trigger Spray Bottle Lid Label:

1. To prepare use solution, open cap. 2. Peel off inner seal by grasping tab at far edge and pulling off. 3. Firmly push small, inner container completely down. 4. Replace cap and tighten. 5. Slowly swirl for 15 seconds. 6. Move spray nozzle to open position.

Gallon Size Bottle Lid Label:

1. To prepare use solution, open cap. 2. Peel off inner seal by grasping far edge and pulling off. 3. Firmly push small, inner container completely down. 4. Replace cap and tighten. 5. Slowly swirl for 15 seconds. 6. Open small side spout and peel off inner seal, as above. 7. Pour solution from small side spout onto surfaces to be treated or

alternate containers. 200 Liter Drum Lid Label: (note: To be used with a Veltek Associates, Inc. pump)

1. Close all valves. 2. Uncoil hoses. 3. Connect center hose to pump between X and Y. 4. Open valve 1, then valve 2, then valve 4. 5. START pump to empty cubic container. 6. When cubic container is empty, turn pump OFF. 7. Close valve 1 and valve 2. 8. Open valve 6 and valve 5. 9. Re-start pump and mix 15 minutes 10. STOP pump. 11. Close valve 4. 12. To dispense – Open valves 3 and 7. Run pump only when

dispensing.




SIMPLEMIX® SYSTEM, 200L CONTAINER OPERATION:




DEC-CYCLE Sterile Pharmaceutical Cleanroom Formula

Low pH Phenolic Germicidal Detergent

Testing Results Summary

*Please contact VAI if summary testing results are required for these organisms

DEC-CYCLE is effective against the following bacteria:

DEC-CYCLE is effective against the following viruses:

DECDE-CYCLE is effective against the following fungi:

Organism Organism Organism

Pseudomonas aeruginosa

Vaccina virus Trichophyton mentagrophytes (the athlete’s foot fungus)

Salmonella enterica

Herpes Simplex Type 2 (HSV 2) Aspergillus fumigatus ATCC

6285

Methicillin Resistant Staphylococcus aureus (MRSA)* HIV-1 (AIDS virus)

Escherichia coli Influenza A2 Virus

Mycobacterium bovis (BCG) Feline Parvovirus*

Staphylococcus aureus Infectious Bursal’s Disease Virus (IBD)*

Salmonella puilorum* Canine Parvo Virus*

Salmonella gallinarum* H1N1 influenza A virus*

Mycoplasma gallisepticum* Avian Influenza Virus*

Pasteurella multocida* Avian Herpes Virus 2 (Mareks Disease)*

Pseudomonas fragi* Avian Bronchitis Virus*

Mycobacterium tuberculosis* Hog Cholera Virus*

Mycoplasma synoviae* Avian Laryngotracheitis Virus*

Bordetella avium* Pseudorabies Virus*

Avian Adenovirus*

African Swine Fever Virus*

Avian Reovirus*




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


Staphylococcus aureus ATCC #6538


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 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

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




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

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

1 Please contact VAI for exact Master Label Testing Statement.




DEC-CYCLE

Sterile Pharmaceutical Cleanroom 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)

VAI’s Sterile Chemical Manufacturing Division - SCMD manufactures a complete range of

cleaning agents and disinfectants that are used daily in cleanroom operations. Overall, VAI’s capabilities for manufacturing products include the ability to fill aerosol, bulk, and unidose packages in ISO 5 (Grade A/B). 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. VAI’s operations mirror current GMP’s and enforces the adherence to USP specifications. VAI is an

EPA and FDA registered facility. To learn more about our division capabilities please visit www.sterile.com

http://www.sterile.com/

low ph, phosphate free, phenolicdec-cycle rev 19jan2016 ml rev: d-15 product description dec-cycle...

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