usp isopropyl alcohol with usp water for...

USP Isopropyl Alcoholwith USP Water for Injection

Sterile Pharmaceutical Clean Room FormulaVEL-203 Rev. 25 June 2012

DECON-AHOL WFI Formula: US EPA Reg. No.: 68959-2 US EPA Est. No.: 68959-PA-01

DECON-AHOL WFI Formula (Aerosol): US EPA Reg. No.: 68959-4

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 1 of 16

Veltek Associates, Inc.

15 Lee Boulevard ● Malvern, PA 19355-1234 Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] VL-203 25 June 2012

DECON-AHOL® Products USP Isopropyl Alcohol with USP Water for Injection

DECON-AHOL products have been developed to address the reduction of possible endotoxin levels that may exist in the use diluted isopropyl alcohol solutions even sterile versions. Addressing the concern, VAI knew that just formulating 99% isopropyl alcohol with USP Water for Injection (WFI) without the concern for the reduction of endotoxin levels throughout the entire manufacturing process would net unacceptable final product endotoxin results. Therefore, after years of development VAI has assured not only the formulation of the products with endotoxin-free USP Water for Injection but also designed the system to assure a closed system manufacture of the product. VAI has also assured the lowest possible endotoxin levels are implemented in elements such as tubing and final containers. The VAI system has provided a final product that is very low in endotoxin levels making it an excellent choice for the critical ISO 5 (Grade A/Class 100) and ISO 7 (Grade C/Class 10,000) aseptic manufacturing conditions. The two EPA registered products, DECON-AHOL WFI Formula and DECON-AHOL Aerosol WFI Formula, are both (70% IPA and 30% USP Water) approved hard surface disinfectant and sanitizer when used according to directions.

DECON-AHOL Aerosol WFI Formula, DECON-AHOL WFI Formula (70% IPA) and DECON-AHOL 60%, DECON-AHOL 91% and DECON-AHOL 99% are formulated with USP WFI that is filtered at 0.2 microns, then double bag packaged and gamma irradiated, all for sterility assurance. The products are available in an 11 oz. aerosol spray (nitrogen propellant), 16 ounce squeeze bottle, 16 and 32 ounce trigger spray, and 1 and 5 gallon containers. The products are completely tested according to USP specifications and are delivered with lot specific Certificate of Irradiation, Certificate of Analysis, LAL Testing Analysis and Sterility Report. The products are completely traceable and have been completely validated for sterility and shelf life. The nitrogen propelled aerosol has the highest quality container available for clean room use today. This package does not permit aspiration of the room air into the master reservoir. Therefore, sterile alcohol is delivered each and every time. Uses: DECON-AHOL® WFI Formula and DECON-AHOL Aerosol WFI Formula are used for the decontamination of items such as gloves, surfaces, carts, counter tops, process lines, and many other applications that require the use of a sterile alcohol solution that is made with USP Water for Injection. DECON-AHOL 60%, 91% and 99% are all excellent cleaners and pre-cleaners.

VAI DECON-AHOL, DECON-AHOL Aerosol WFI Formula and DECON-AHOL WFI Formula (70% IPA) EPA registered products: Order# Description Quan/cs. DECWFI-SP-70 70% 11 oz. Aerosol Mist Spray Sterile 24 DECWFI-ST-70 70% 11 oz. Aerosol Stream Spray Sterile 24 DECWFI-SP-70-B 70% 11 oz. InvertaSpray Aerosol Mist Spray Sterile 24 DECWFI-NSP-70 70% 11 oz. Non-Aerosol Mist Spray Sterile 24 DECWFI-B-70 70% 1 Gallon Sterile 4 DECWFI-TR-04 70% 16 oz. Trigger Spray Sterile (Attached Sprayer) 12 DECWFI-TR-05 70% 32 oz. Trigger Spray Sterile (Attached Sprayer) 12 DECWFI-SQ-16Z 70% 16 oz. Squeeze Bottle Sterile (Individual Double Bag) 12 DECWFI-SQ-03 70% 16 oz. Squeeze Bottle Sterile (Bulk Double Bag) 12 DECWFI-B-70-5G 70% 5 Gallon Sterile 1 DECWFI-BOT-01 DECON-AHOL WFI Non-Sterile IPA bottles for Asepti-Cleanse 32oz fill 12 DECWFI-BOT-02 DECON-AHOL WFI Sterile IPA bottles for Asepti-Cleanse 32oz fill 12 VAI DECON-AHOL 60%, DECON-AHOL 91% and DECON-AHOL 99% WFI products: DECWFI-B-60 60% 1 Gallon Sterile 4 DECWFI-B-91 91% 1 Gallon Sterile 4 DECWFI-B-91-5G 91% 5 Gallon Sterile 1 DECB-99 99% 1 Gallon Sterile 4

DEC-301 Asepti-Cleanse Dispenser for DECON-AHOL WFI Bottles (4D Cell or 110V) 1

* DECON-AHOL Aerosol Products are Processed, Packaged and Sterilized according to U.S. Pat. No. 6,123,900.

Available Technical Data Supplements (Upon Request) VL-201: DECON-AHOL WFI Spray Product Validation VL-202: DECON-AHOL WFI Bulk Container Product Validation




DECON-AHOL® Sterile WFI Formula Manufacturing and Testing

The first consideration in choosing DECON-AHOL products is to review the GMP manufacturing and testing that is incorporated into Veltek Associates, Inc. manufacturing and testing operations. They are unequaled in the industry! We offer and suggest you audit VAI operations!

Manufacturing All DECON-AHOL WFI Formula 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/or FDA registered and follow cGMP’s All DECON-AHOL WFI Formula Products are Manufactured in accordance with cGMP's All DECON-AHOL WFI Formula Products are made with USP Isopropyl Alcohol and USP Water for Injection All DECON-AHOL WFI Formula products are manufactured utilizing dedicated equipment and processes. All DECON-AHOL WFI Formula manufacturing areas (ISO 5, Grade A (Class 100), ISO 7, Grade C (Class 10,000)) are controlled and monitored for particulate and microbials. All DECON-AHOL WFI Formula containers are air washed with 0.2 micron filtered air to assure particle removal before filling. All DECON-AHOL WFI Formula Containers are inspected for quality after filling. All DECON-AHOL WFI Formula Sterile products are packaged in the controlled environment into double bags and then the case contents are packaged into two polyethylene case liners within the carton. All DECON-AHOL WFI Formula packaging bags are ISO 5, Grade A (Class 100) Certified Bags All DECON-AHOL WFI Formula products are filtered through a pre-sterilized 0.2 um filter All filters are Bubble Point Tested after use. All DECON-AHOL WFI Formula packaged cartons are then sterilized through a validated gamma irradiation sterilization cycle as proven by both an AAMI validation and a 10-6 reduction of B. pumilus spores. All DECON-AHOL WFI Formula products are released only after successful conformance testing by VAI’s Quality Assurance

Testing

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




DECON-AHOL® Products SPECIFICATIONS

Specification DECON-AHOL WFI Formula & DECON-AHOL Aerosol WFI Formula (EPA registered)

DECON-AHOL 91% DECON-AHOL 60% DECON-AHOL 99%

Filtration: 0.2 Micron Absolute 0.2 Micron Absolute 0.2 Micron Absolute 0.2 Micron Absolute

Appearance: Colorless Liquid Colorless Liquid Colorless Liquid Colorless Liquid

Assay: 68.0%-72.0% v/v 89.0%-93.0%v/v 58.0%-62.0%v/v 98.1-99.5%v/v

Acidity: <1 ml. <0.7 ml. <1 ml. <0.7 ml.

Specific Gravity: 0.872-0.883 g/cc 0.810-0.821 g/cc 0.896-0.906 g/cc 0.783-0.787 g/cc

Nonvolatile Residue: <5 mg. (<0.01%) <2.5% <5 mg. (<0.01%) <2.5%

Irradiation Range: 25.0 - 50.0 kGy 25.0 - 50.0 kGy 25.0 - 50.0 kGy 25.0 - 50.0 kGy

Sterility: Sterile Sterile Sterile Sterile

Aerosol Pressure (If Applicable):

90-130 psi. 90-130 psi. N/A N/A

Max. Temperature: 120 degrees F 120 degrees F 120 degrees F 120 degrees F

Min. Temperature: 32 degrees F 32 degrees F 32 degrees F 32 degrees F

Flash Point: 75 degrees F 62 degrees F 79 degrees F 54 degrees F

Expiration: 3 Years 3 Years 3 Years 3 Years

Water For Injection (formulation):

less than 0.25 eu/mL N/A

LAL Testing Less than 0.45 eu/ml. Less than 0.45 eu/ml. Less than 0.45 eu/ml. Less than 0.45 eu/ml.

Testing Parameters: CURRENT USP COMPENDIUM** CURRENT USP

COMPENDIUM** CURRENT USP COMPENDIUM**

CURRENT USP COMPENDIUM**

Filled in: ISO 5 – ISO 7 (Grade A/B/C, Class 100 – Class 10,000) cGMP Manufacturing Conditions for all DECON-AHOL® products

Containers: Air washed in .2µm filtered air prior to filling all DECON-AHOL Products.

Manufactured by: Veltek Associates, Inc. VAI is an EPA and FDA Registered Manufacturing Facility (Audits are encouraged and welcomed)

** As no monograph exists in CURRENT USP COMPENDIUM, testing ranges for DECON-AHOL 60%, 91% & 99% were established using the 70% monograph

DECON-AHOL Aerosol Products are Processed, Packaged and Sterilized according to U.S. Pat. No. 6,123,900.




Available Containers

DECON-AHOL® Aerosol WFI Formula Stream and Mist:

In use since 1988, the DECON-AHOL Aerosol WFI Formula container is available in an 11 ounce stream spray (precipitating like a squirt bottle) and an aerosol mist (broader fine droplet spray). This container does not aspirate the room air to the master reservoir of alcohol and assures a sterile solution is precipitated from first use until last. This is important as one can eliminate contaminates from entering the solution from the clean room environment. This container fits easily into the DECON-AHOL DEC-501 Forearm Activated Dispenser or the DEC-100 Hands Free Dispenser

DECON-AHOL Aerosol WFI Formula InvertaSpray® System:

The DECON-AHOL Aerosol WFI Formula InvertaSpray container is available in an 11 ounce aerosol mist container that can spray UPSIDE DOWN, RIGHT SIDE UP OR HORIZONTALLY. This container uses a bag system and does not aspirate the room air to the master reservoir of alcohol and assures a sterile solution is precipitated from first use until last. This is important as one can eliminate contaminates from entering the solution from the clean room environment. The InvertaSpray System is excellent for areas when spraying at difficult angles becomes necessary.

DECON-AHOL WFI Formula Trigger Spray Containers:

The DECON-AHOL WFI Formula Trigger Spray Containers are available in both 16 ounce and 32 ounce sizes. The containers are available with or without the trigger mechanism attached to the container. The trigger sprayer attached containers eliminate the need for an aseptic connection to be made by the end user before use. All trigger spray containers afford the user the ability to choose a mist, stream and off position by easily adjusting the nozzle. These containers are an excellent choice where the use of the aerosol or non-aerosol containers is not possible.

DECON-AHOL WFI Formula Squeeze Bottle Containers:

The DECON-AHOL WFI Formula Squeeze Bottle Containers are available in both 8 ounce and 16 ounce sizes. A majority of large-scale FDA registered production operations have utilized this container from VAI for over 11 years. The containers are manufactured with the spray nozzle atop the container eliminating the need for an aseptic connection to be made by the end user before use. The end user has only to remove the tip cover (syringe sheath) and the container is ready to use. These containers are an excellent choice where the use of the aerosol or non-aerosol container is not possible.




DECON

Which Container to Choose?

The choice of a container is based on the intended use of the product and confines of the manufacturing process where the product is to be used. Most GMP facilities use a variety of containers within their operations to satisfy the unique needs of each situation. This is an excellent methodology that will not only assure the use of the correct container but also reduce the volume of alcohol used on an annual basis. Your local VAI Technical Support Representative can assist you in assuring all consideration are made prior to use of a container size. Please contact VAI at 1-888-4-STERILE (1-888-478-3745) for your local representative.

DECON-AHOL® WFI Formula 1-Gallon Containers:

The DECON-AHOL WFI Formula & DECON-AHOL 60%, 91% & 99% 1-gallon containers are an excellent choice for GMP operations that require a larger volume of sterile alcohol to be used at one time or over a short time period. While pouring of such containers to a trigger spray or a squeeze bottle is acceptable, concerns for sterility of the solution during this in-house operation need to be considered. These containers are better used within the package provided by VAI. These containers may incorporate either the 300-T Trigger mechanism or the 200-P Pump unidose dispensing mechanism by VAI.

DECON-AHOL WFI Formula 5-Gallon Containers:

The DECON-AHOL WFI Formula 5-gallon containers are an excellent choice for GMP operations that require a larger volume of sterile alcohol to be used at one time or over a short time period. While pouring of such containers to a trigger spray or a squeeze bottle is acceptable, concerns for sterility of the solution during this in-house operation need to be considered. These containers are better used within the package provided by VAI. These containers include a pour top dispensing mechanism within the sterile package provided by VAI.

DECON-AHOL WFI Formula Asepti-Cleanse Bottles & Dispenser:

The DECON-AHOL WFI Formula Asepti-Cleanse Bottles and Dispenser are an excellent choice for GMP operations that require a photo-eye operated pre-measured dispensing system. The DECON-AHOL WFI Formula Asepti-Cleanse Bottles and Dispenser do not aspirate the room air to the master reservoir and are sterile from first use till last. DECON-AHOL WFI Formula Asepti-Cleanse Bottles and Dispenser are designed in a dual power configuration of power supply. The Asepti-Cleanse® Dispensing System (DEC-301 unit) can be powered by 4D cell batteries (4D cell last over 1 year) or connected directly to 110V in the same unit. See product information: ASP-CLS-01 for complete details.




DECON-AHOL® WFI FORMULA (Gamma Irradiated)

For Use in Clean Rooms and Controlled Areas

Hard Surface Disinfectant and Sanitizer

Active Ingredients: Isopropyl Alcohol CAS# 67-63-0……………………70.0% Other Ingredients: USP Water for Injection……………………………...30.0% TOTAL……………………………………………..100.0%

KEEP OUT OF REACH FROM CHILDREN

DANGER – FLAMMABLE

Keep away from open flame. Store at room temperature below 48.8˚C (120˚F)

See other panel for first aid and additional precautions See container for lot number and storage expiration date

US EPA Reg. No.: 68959-E US EPA Est. No.: 68959-PA-001 Canadian DIN: xxxxxx Manufactured by: Veltek Associates, Inc. 15 Lee Blvd. Malvern, PA 19355-1234 In Canada: Distributed by: Canada Clean Room 280 Terence Matthews Kanata, ON K2M 2C6 Inquiries: (888) 595-8070

Net Contents: (In Canada XXXX mL or Liters) (In US XXX oz or gallons)




FIRST AID

If swallowed

Call a poison control center or doctor immediately for treatment advice. Have person sip a glass of water if able to swallow. Move person to fresh air. Do not induce vomiting unless told to by a poison control center or doctor. Do not give anything to an unconscious person.

If inhaled Move person to fresh air. If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth if possible. Call poison control center or doctor for treatment advice.

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

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGER: Not for personal use. Not for use on or around food. Do not get on skin or in eyes. Do not take internally and do not inhale vapor. PHYSCIAL AND CHEMICAL HAZARDS: This product may be irradiating to eyes, skin, gastrointestinal tract and respiratory system. May cause central nervous system depression. Flammable liquid vapor. Vapor may cause flash fire. Keep away from heat, sparks, direct sunlight, and open flame. Do not mix this product with other chemicals including, acids, oxidizing materials, combustible materials, halogens, peroxides, bases and metal salts. Do not puncture or incinerate container. Exposure to temperatures above 48.80 C (1200F) may cause bursting. PERSONAL PROTECTIVE EQUIPMENT: Wear eye protection goggles and face shield. Wear chemical-resistant gloves. Use supplied air respirators if levels exceed OSHA PEL.

DIRECTIONS FOR USE Read the label and leaflet before using

In the United States: It is a violation of U.S. law to use this product without having obtained the U.S. label at the time of purchase and following the U.S. label at the time of application.

In Canada: This product is to be used only in accordance with the directions on the label. It is an offence to use this product in a way that is inconsistent with the directions on the label. The user assumes the risk to persons and property that arises from any such use of this product.




USE: Disinfects and sanitizes cleanrooms and controlled areas such as those used in healthcare institutions, biopharmaceutical, pharmaceutical, medical device and diagnostic manufacturing facilities. May be used to disinfect hard, inanimate surfaces in aseptic filling and gowning rooms, general manufacturing areas, or on machinery, tools, tables, counters, laminar flow benches, floors, walls, carts, shelves and glass. It is compatible with most hard surface materials. DISINFECTION: Use this product while wearing personal protection such as eye protection and chemical-resistant gloves. Use with adequate ventilation and spray away from eyes and face. DECON-AHOL® is ready to use. Do not dilute. Pre-clean surface or item of heavy soil or gross filth before application. Hold can upright 6-12 inches from surface. Thoroughly wet surface with DECON-AHOL and allow to remain wet for a minimum of 10 minutes. Allow surface to air dry, or after 10 minutes wipe dry with sterilized cloth, wiper, if needed. DECON-AHOL is bactericidal. The results of AOAC Efficacy Tests show that DECON-AHOL is an effective hard surface disinfectant against Pseudomonas aeruginosa (ATCC# 15442), Staphylococcus aureus (ATCC#6538), and Salmonella enterica (ATCC# 10708) in the presence of fetal bovine serum organic load in 10 minutes. SANITIZATION: For use on hard, non-porous environmental surfaces (made from: stainless steel, glass, Corian™ , laminate flooring, aluminum, pvc, mild steel, polypropylene), in isolators, cleanrooms, sterile and controlled areas, gowning rooms and on process lines, gloves, work surfaces, tools and equipment. DECON-AHOL is an effective sanitizer on inanimate, non-food contact surfaces against Staphylococcus aureus (ATCC#6538) and Klebsiella pneumonia (ATCC# 4352) in the presence of fetal bovine serum organic load in 5 minutes.

Storage and Disposal Do not contaminate water, food, or feed by storage and disposal.

Storage: Store in the original container in a dry cool place below 48.80C (1200F). Disposal: Pesticide wastes are toxic. Follow Federal/Provincial/State regulations and Local/Municipal ordinances when disposing of this product. Improper disposal of excess product, spray mixture or rinsate is a violation of Federal/ Provincial /State Laws. If these wastes cannot be disposed of by use according to label instructions, contact your Federal/Provincial/State regulations or Local/Municipal environmental control agency for guidance. Never place unused product down any indoor or outdoor drain. Container Disposal: Non-fillable container. Do not reuse or refill this container. Do not puncture container and do not incinerate container. Offer for recycling, or dispose of in a sanitary landfill. FIRST RESPONDERS – For Spill/Exposure Emergency Response Services in English (and 26 languages) +44 208 762 8322, Arabic +961 3 487 287, Chinese +86 10 5100 3039. Calls originating from the USA or Canada prefix (+) with 011.




DECON-AHOL®mc AEROSOL WFI Formula

(Gamma Irradiated)

For Use in Clean Rooms and Controlled Areas

Hard Surface Disinfectant and Sanitizer

Active Ingredients: Isopropyl Alcohol CAS# 67-63-0……………………70.0% Other Ingredients: USP Water for Injection……………………………...30.0% TOTAL……………………………………………..100.0%

KEEP OUT OF REACH FROM CHILDREN

DANGER

FLAMMABLE - EXPLOSIVE Keep away from open flame.

Contents under pressure. Store at room temperature below 48.8˚C (120˚F)

See other panel for first aid and additional precautions

See container for lot number and storage expiration date

US EPA Reg. No.: 68959-4 US EPA Est. No.: 68959-PA-001 Canadian DIN: 02351382 Manufactured by: Veltek Associates, Inc. 15 Lee Blvd. Malvern, PA 19355-1234 In Canada: Distributed by: Canada Clean Room 280 Terence Matthews Kanata, ON K2M 2C6 Inquiries: (888) 595-8070

Net Contents: (In Canada XXXX mL or Liters) (In US XXX oz or gallons)




FIRST AID

If in eyes If splashed in eyes, hold eyes open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present, after the first five minutes, then continue rinsing eye. Call poison control center or doctor for 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. Move person to fresh air. Do not induce vomiting unless told to by a poison control center or doctor. Do not give anything to an unconscious person. Have product container or label with you when calling a poison control center or doctor, or going for treatment.

If inhaled Move person to fresh air. If person is not breathing, call 911 or an ambulance, then five artificial respiration, preferably mouth-to-mouth if possible. Call poison control center or doctor for 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 treatment advice.

EMERGENCIES: For Spill/Exposure/Poison Control Emergency Response Service from the USA and Canada in English, French and Spanish (and 23 other languages) call CareChem24 toll free at 866-928-0789.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS AND DOMESTIC ANIMALS DANGER: Corrosive. Causes irreversible eye damage. Harmful if swallowed or inhaled. Do not get in eyes or on clothing. Avoid breathing vapor or spray mist. Avoid contact with skin or clothing. Wear protective eyewear such as goggles or face shield, protective clothing and chemical resistant gloves. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum or using tobacco or using the toilet. Remove and wash contaminated clothing before reuse. Prolonged or frequently repeated skin contact may cause allergic reactions in some individuals. PHYSCIAL AND CHEMICAL HAZARDS: Contents under pressure. Flammable liquid and vapor. Vapor may cause flash fire. Keep away from heat, sparks, and open flame. Do not mix this product with other chemicals including: acids, oxidizing materials, combustible materials, halogens, peroxides, bases and metal salts. Do not puncture or incinerate container. Exposure to temperature above 48.80C (1200 F) may cause burning.

DIRECTIONS FOR USE Read the label and leaflet before using

In the United States: It is a violation of U.S. law to use this product in a manner inconsistent with its labeling. In Canada: This product is to be used only in accordance with the directions on the label. It is an offence to use this product in a way that is inconsistent with the directions on the label.




This product is NOT to be used as 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 area of the body. This product may be used to pre-clean or decontaminate critical or semi-critical medical devices prior to sterilization or high-level disinfection.

USE: Disinfects and sanitizes cleanrooms and controlled areas including those used in healthcare institutions, biopharmaceutical, pharmaceutical, medical device and diagnostic manufacturing facilities. Use on hard, non-porous, inanimate surfaces in aseptic filling and gowning rooms, general manufacturing areas, or on machinery, tools, tables, counters, laminar flow benches, floors, walls, carts, shelves made of hard non-porous materials, such as glass, plastic, vinyl, chrome and stainless steel. It is compatible with most hard surface materials.

DISINFECTION: Use this product while wearing personal protection. Wear protective eyewear such as goggles or face shield, protective clothing and chemical-resistant gloves. Use with adequate ventilation and spray away from eyes and face. DECON-AHOL® AEROSOL is ready-to-use. Pre-clean surface or item of heavy soil or gross filth before application. Hold can upright 6 – 12 inches from surface. Thoroughly wet surface with DECON-AHOL AEROSOL and allow to remain wet for 10 minutes. Allow surface to air dry, or after 10 minutes wipe dry with sterilized cloth, wiper, if needed.

DECON-AHOL is bactericidal. The results of AOAC Efficacy Tests show that DECON-AHOL AEROSOL is an effective hard surface disinfectant against Pseudomonas aeruginosa (ATCC# 15442), Staphylococcus aureus (ATCC#6538), and Salmonella enterica (ATCC# 10708) in 10 minutes.

SANITIZATION: Use a 5 minute contact time on hard, non-porous surfaces (made from: stainless steel, glass. Corian™, laminate flooring, aluminum, pvc, mild steel, polypropylene) in isolators, clean rooms, sterile and controlled areas, gowning rooms and on process lines, gloves, work surfaces, tools and equipment.

DECON-AHOL AEROSOL is an effective sanitizer on inanimate, non-food contact surfaces against Staphylococcus aureus (ATCC#6538) and Klebsiella pneumonia (ATCC# 4352) in 5 minutes.

Storage and Disposal Do not contaminate water, food, or feed by storage and disposal.

Storage: Store in the original container in a dry cool place below 48.80C (1200F). Disposal: Product and product wastes are toxic. Follow Federal/Provincial/State regulations and Local/Municipal ordinances when disposing of this product. Improper disposalof excess product is a violation of Federal/Provincial/State Laws. If these wastes cannot be disposed of by use according to label instructions, contact your Federal/Provincial/State or Local/Municipal environmental control agency for guidance. Container Disposal: Non-fillable pressurized container. Do not reuse or refill this container. Do not puncture container and do not incinerate. If empty, offer for recycling, if available. If partly filled: call local solid waste agency for disposal instructions.




Cost Evaluation of In-house Manufacture

Assure all the costs are included in your evaluation or you are losing money! Presented is a simple guide to assist you in your evaluation.

Purchase Alcohol Receiving Inspection Formulation Sterilizing Components Create Sterilization

Records for Components

Purchase Alcohol Receive Batch Formula Records Containers

Quarantine Formulations Area Caps Sterility

Sample Formulation Equipment Labels Particulate Matter

Release Change Over Procedure LAL

Solvent Storage Sterile Records:

Cert. of Analysis - Filter

- Lines

- Receiving Vessel

- Sterile Receive Vessel

Total = $ 8.00/gallon Total = $ 8.00/gallon Total = $ 20.00/gallon Total = $ 10.00/gallon Total =$ 6.00/gallon

Perform QA Testing Quarantine Product Safety Storage Overhead Total Costs

Sterility 7 days Bagged Amortization of Equip.

Particulate Matter Shelf Life Records/ inventory Space

Cert. of Analysis Insurance

Training

Total = $12.00/gallon Total = $ 3.00/gallon Total = $ 2.00/gallon Total = $ 36.00/gallon Total $105.00/gallon

Calculations do not include terminal sterilization of the final contents Calculations do not include Double bagging of final sterile product Calculations do not include validation studies and expiration testing




DECON-AHOL® WFI FORMULA

Lot Specific Sterile Documentation

(received with each shipment)

Certificate of Analysis Certificate of Sterility

Certificate of Irradiation LAL Test Report (on file)

(Please contact VAI for a sample of this documentation)

This document should not be used for acceptance criteria. Please contact a VAI representative

for sample documentation.




Efficacy Testing Results Summary: Results for DECON-AHOL® Aerosol WFI Formula & DECON-AHOL WFI Formula (70% Isopropyl Alcohol in WFI) 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

2.78 X 10^6 CFU/Carrier A 60 0/60

B 60 0/60

C 60 0/60

Salmonella enterica ATCC #10708

1.81 X 10^5 CFU/Carrier A 60 0/60

B 60 0/60

C 60 0/60

Staphylococcus aureus ATCC #6538 2.66 X 10^6 CFU/Carrier A 60 0/60

B 60 0/60

C 60 0/60

Testing per ASTM Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces, Germicidal Spray Method in the presence of 5% organic soil showed sanitization was effective. Five carriers were used per 3 separate lots, all of which were > 60 days old. This product is considered a sanitizer in this test when test results show a reduction of at least 99.9% (3 Log10) in the average numbers of each test microorganism on each carrier count within 5 minutes. Organism AvgCarrier Population Sample Lot AvgSurvivors/Carrier Percent Kill

Staphylococcus aureus ATCC #6538

4.17x10^6 A <2x10^1 >99.9 B <2x10^1 >99.9 C <2x10^1 >99.9

Klebsiella pneumonia ATCC #4352

1.07x10^6 A <2x10^1 >99.9 B <2x10^1 >99.9 C <2x10^1 >99.9




Results for DECON-AHOL® Aerosol WFI Formula & DECON-AHOL WFI Formula (70% Isopropyl Alcohol in WFI) This product is bactericidal according to the AOAC Use Dilution Test Germicidal Spray Method on hard inanimate surfaces when not more than 1 out of 60 carriers are positive for growth in 10 minutes. (Total carriers = 540).) Organism Carrier Population Sample Lot (All >60

days old)# Carriers # Positive

Pseudomonas aeruginosa ATCC #15442

7.5 X 10^6 CFU/Carrier A 60 0/60

B 60 0/60

C 60 0/60

Salmonella enterica ATCC #10708

8.9 X 10^4 CFU/Carrier A 60 0/60

B 60 0/60

C 60 0/60

Staphylococcus aureus ATCC #6538 4.6 X 10^6 CFU/Carrier A 60 0/60

B 60 0/60

C 60 0/60

Testing per ASTM Standard Test Method for Efficacy of Sanitizers Recommended for Inanimate Non-Food Contact Surfaces, Germicidal Spray Method showed sanitization was effective. Five carriers were used per 3 separate lots, all of which were > 60 days old. This product is considered a sanitizer in this test when test results show a reduction of at least 99.9% (3 Log10) in the average numbers of each test microorganism on each carrier count within 5 minutes. Organism AvgCarrier Population Sample Lot AvgSurvivors/Carrier Percent Kill

Staphylococcus aureus ATCC #6538

1.78x10^6 A <2x10^1 >99.9 B <2x10^1 >99.9 C <2x10^1 >99.9

Klebsiella pneumonia ATCC #4352

8.32x10^6 A <2x10^1 >99.9 B <2x10^1 >99.9 C <2x10^1 >99.9

Room Type/Surface Minimum Frequency* Method Application Product (Must be STERILE) ISO 5 Primary Engineering Controls • LAFW • BSC • CAI • CACI

• Beginning of each shift ____________________

• Before each batch • Every 30 minutes during

compounding • When spills occur • When surface contamination is

known/suspected

Wipe Wipe

Cleaning/Disinfecting Disinfecting Disinfecting

1. Decon-Quat 200C followed by: 2. Decon-Ahol 70% IPA

Decon-Ahol 70%IPA

Monthly or quarterly based in response to EM micro monitoring results

Wipe

Cleaning Sporicidal

1. Decon-Clean followed by: 2. Decon-Spore 200 Plus

Or 0.52% Hypo-Chlor Or 6% Steri-Perox

During use as required Wipe Decon-Ahol 70% IPA ISO 7 & 8 - Buffer Area & Anteroom Counters, Work surfaces, door plates, handles, gowning benches

Daily Wipe Cleaning/Disinfecting Decon-Quat 200C

Floors Daily (when no aseptic operations are in progress)

Mop Cleaning/Disinfecting Decon-Quat 200C

Monthly or quarterly based in response to EM micro monitoring results

Mop Cleaning Sporicidal

1. Decon-Clean followed by: 2. Spore 200 Plus

Or 0.52% Hypo-Chlor Or

6% Steri-Perox ** Walls & Ceilings Monthly Mop Cleaning/Disinfecting Decon-Quat 200C

Quarterly or yearly based in response to EM micro monitoring results

Mop Cleaning Sporicidal

1. Decon-Clean followed by: 2. Spore 200 Plus Or

0.52% Hypo-Chlor Or

6% Steri-Perox ** Storage Shelving Monthly Wipe Cleaning/Disinfecting Decon-Quat 200C In-coming Supplies As needed Wipe Disinfecting Decon-Ahol 70% IPA

Or 6% Steri-Perox Saturated Wipe

*Always refer to site specific SOP’s for cleaning and disinfection instructions. ** Consider MSDS PEL before applying.

Product Dilutions/Applications

Product Dilution Application Decon-Ahol 70% IPA RTU Disinfecting

6% Steri-Perox 6% RTU Sporicidal Decon-Quat 200C 1:128 RTU Cleaning/Disinfecting

Decon-Spore 200 Plus 6.4:128 RTU Sporicidal 0.52% Hypo-Chlor 0.52% RTU Sporicidal

Decon-Clean 1:128 RTU Cleaning 6% Saturated Steri-Perox Wipe RTU Decontamination

Wipedown HC - Sterile non-shedding drywipe

NOTE: All products used in the critical classified area must be sterile.

usp isopropyl alcohol with usp water for...

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