Technical Notes and Research Data

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1 Technical Notes and Research Data Actril Cold Sterilant Revised 1/7/03 This document is intended to be a supplement to the Actril Directions for Use. It is important that you read and understand the Directions for Use prior to using Actril Cold Sterilant. Disinfectants/Sterilants

2 Table of Contents Table of Contents History Who is Minntech Renal Systems? What does Minntech Renal Systems know about sterilants? What is Actril Cold Sterilant? How has peracetic acid been used as a sterilant? How does peracetic acid work? How effective is Actril Cold Sterilant as a sterilant? Is Actril Cold Sterilant biodegradable? Is Actril Cold Sterilant compatible with Renalin Cold Sterilant? Where is Actril Cold Sterilant registered? Efficacy How does peracetic acid work? How fast does Actril Cold Sterilant work? How do I know Actril Cold Sterilant is effective? How long is Actril Cold Sterilant effective? Compatibility With what type of devices and materials is Actril Cold Sterilant compatible?.7 Safety Issues How safe is Actril Cold Sterilant? Does Actril Cold Sterilant contain any aldehyde groups similar to those found in glutaraldehyde? Why does Actril Cold Sterilant smell like vinegar? Handling Recommendations Are special ventilation systems required? How should Actril Cold Sterilant be handled? Does Actril Cold Sterilant require mixing, activation, or dilution? How do I clean up an Actril Cold Sterilant spill? How should I dispose of Actril Cold Sterilant? How long will Actril Cold Sterilant last under normal storage conditions?....9 References Page 2

Who is Minntech Renal Systems? Minntech s dialysis product division, Renal Systems, manufactures supplies used in treating patients suffering from end-stage renal disease, or kidney failure.

What is Minntech Renal System s experience with sterilants? Medical device reprocessing systems and sterilants are two of Minntech s oldest and most trusted product lines.

Renalin Cold Sterilant, the Company s leading peracetic acid cold sterilant product, is used by more U.S. dialysis facilities than any other dialyzer reprocessing product.

medical devices without harmful aldehyde by-products. Beyond medical device reprocessing, Minntech s sterilant technologies have found numerous applications in other clinical and industrial settings.

3 Who is Minntech Renal Systems? Minntech s dialysis product division, Renal Systems, manufactures supplies used in treating patients suffering from end-stage renal disease, or kidney failure. Renal Systems is a leading U.S. manufacturer of both liquid and powdered acetate and bicarbonate hemodialysis concentrates, as well as dialyzer reprocessing systems and sterilants. What is Minntech Renal System s experience with sterilants? Medical device reprocessing systems and sterilants are two of Minntech s oldest and most trusted product lines. The Renatron Dialyzer Reprocessing System, Minntech s first reprocessing product, was introduced in 1982 and today is the worldwide leader in automated dialyzer reprocessing systems. Renalin Cold Sterilant, the Company s leading peracetic acid cold sterilant product, is used by more U.S. dialysis facilities than any other dialyzer reprocessing product. Actril Cold Sterilant, introduced in 1987, replaced formaldehyde and glutaraldehyde with a stabilized mixture of peracetic acid, hydrogen peroxide, and acetic acid for powerful disinfection of medical devices without harmful aldehyde by-products. Beyond medical device reprocessing, Minntech s sterilant technologies have found numerous applications in other clinical and industrial settings. Bacteria removal is an important concern in laboratories and manufacturing environments that maintain high-purity water systems. Minntech s other peracetic acid cold sterilant, Minncare Cold Sterilant has been cleaning and sanitizing reverse osmosis membranes and water distribution systems since Backed by years of extensive research and proven performance, Minntech s entire family of peracetic acid-based sterilants and disinfectants are completely formaldehyde- and glutaraldehyde-free to safeguard patients, healthcare personnel, and the environment. Who is Minntech Renal Systems? What does Minntech Renal Systems know about sterilants? Page 3

4 What is Actril Cold Sterilant? Peracetic acid is used as a sterilant. Actril Cold Sterilant is biodegradable. What is Actril Cold Sterilant? Actril Cold Sterilant is a stabilized mixture of peracetic acid, hydrogen peroxide, and acetic acid. Because it is formaldehyde-free and gluteralehyde-free, Actril Cold Sterilant allows you to practice proven effective, state-of-the-art disinfection while safeguarding your patients and staff. How has peracetic acid been used as a sterilant? Beyond medical device reprocessing, peracetic acid has been accepted worldwide in the food processing and beverage industries. Its powerful antimicrobial action at low temperatures and absence of toxic by-products make peracetic acid appropriate for applications in meat and poultry processing plants, canneries, dairies, breweries, wineries, soft drink plants and agriculture. Peracetic acid is also ideal for clean-in-place (CIP) systems, and is used as a terminal disinfectant or sterilant for stainless steel and glass tanks, piping, tank trucks, and railroad tankers. 1 How does peracetic acid work? Peracetic acid will react with sulfhydryl and sulfur-sulfur bonds in proteins as well as carbon-carbon double bonds as found in many lipids. 2 As a result, the peracetic acid can deactivate critical enzymes and disrupt cell membranes by oxidizing membrane components. Is Actril Cold Sterilant biodegradable? The stabilized mixture of peracetic acid, hydrogen peroxide, and acetic acid leaves no toxic residues. After reacting with organic material, Actril Cold Sterilant decomposes into oxygen and acetic acid. In addition, it is biodegradable in waste water. Is Actril Cold Sterilant compatible with Renalin Cold Sterilant? Actril Cold Sterilant is completely compatible with Minntech Renal Systems Renalin Cold Sterilant. Where is Actril Cold Sterilant registered? Actril Cold Sterilant can be sold in the United States (EPA Reg. No ), Canada (DIN No ), the European Union, as well as several Central and South American countries. Actril Cold Sterilant carries the CE mark. How fast does Actril Cold sterilant work? Actril Cold Sterilant is fast, effective and does not require heating. Efficacy Claim Exposure Time % Kill 20 C (68 F) 5.5 hours 100% High Level Disinfection* 10 minutes 100% 20 C (68 F) *Sterilization is defined as the destruction of all living organisms and is verified by the germicide s ability to destroy bacterial endospores. The exposure time for high-level disinfection is established by determining the time required for the germicide to destroy high numbers of mycobacteria. Page 4

5 How do I know Actril Cold Sterilant is effective? Testing demonstrates that as a full strength sterilant, Actril Cold Sterilant completely destroys all microorganisms, including: viruses, bacteria, spores, and fungi. It is effective against Pseudomonas aeruginosa, Bacillus subtilis, nontuberculosis mycobacteria (NTM), hepatitis B virus, and HIV (the virus associated with AIDS). When subjected to the testing accepted by the American Organization of Analytical Chemists (AOAC), the EPA, and the FDA, Actril Cold Sterilant has proven to be an effective sterilant. The following chart shows results of efficacy testing performed with undiluted sterilant (except where noted) that had been stressed for 14 days by means of simulating the bioburden load which would be introduced to the sterilant by the repeated disinfection of clean but microbially contaminated equipment. Actril Cold Sterilant is effective. Type Spores Organism Bacillus subtilis Clostridium sporogenes Contact Time Tested at 68 F (20 C) Test Results 5.5 hours 100% kill of 104 endospores Mycobacteria Mycobacterium bovis 10 minutes 100% kill of 106 microoranisms Vegetative Organisms Pseudomonas aeruginosa Salmonella choleraesuis Staphylococcus aureus 10 minutes Diluted 1:10 100% kill of 104 bacteria Fungi Trichophyton mentagrophytes 10 minutes 100% kill of 105 spores Non-lipid small virus Polio virus Type 2 15 minutes 100% kill of 105 viruses Lipid medium virus Herpes simplex Type 1,2, HIV (AIDS virus) 3 minutes Herpes - Diluted 1:10 HIV - Diluted to MEC 100% kill of Herpes viruses 100% kill of HIV 104 viruses Hepatitis B and C No approved method to test for hepatitis B&C exists. * N/A N/A * A direct test is unavailable, however they are generally considered easier to kill than Polio viruses Page 5

6 Actril Cold Sterilant can be re-used. How long is Actril Cold Sterilant effective? Actril Cold Sterilant can be re-used for its labeled shelf life for as long as it is in the original container and is resealed. Minntech Renal Systems recommends that effectivity testing be performed before each use. Actril Cold Sterilant can be re-used for up to 14 days and as long as the minimum effective concentration (MEC) of peracetic acid is present. The MEC for Actril Cold Sterilant is 500 ppm peracetic acid. The MEC should be tested prior to each use with Actril Peracetic Acid Indicator Test Strips. The solution should not be used after 14 days have lapsed even if the indicator strips show the level of peracetic acid to be over the MEC. As the graph below indicates, Actril Cold Sterilant remains well above the minimum effective concentration of 500 ppm peracetic acid even after 14 days of rigorous stressing according to the Re-use Test Protocol provided by the United States Environmental Protection Agency (EPA). Reuse life of Actril Cold Sterilant solution was determined by stressing it according to the Re-Use Test Protocol provided by the United States Environmental Protection Agency (EPA). 3 The EPA test protocol specifies both the repeated addition of bioburden (Bacillus subtilis, Clostridium sporogenes, Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella choleraesuis) and exposure to inhalation therapy equipment. Page 6

7 With what type of devices and materials is Actril Cold Sterilant compatible? Actril Cold Sterilant has been tested and shown to be compatible with material coupons and medical devices made from the materials shown below: Actril Cold Sterilant is compatible with most medical device materials. Metals Plastics Elastomers Stainless Steel (316) Polyproylene Silicone rubber Aluminum Alloy (6061) Teflon Acrylonitrile-butadienestyrene (ABS) Polyethylene Polyvinylchloride (PVC) Polycarbonate Tygon Do not use Actril Cold Sterilant with brass or copper. Other materials not listed should be tested for compatibility prior to use. How safe is Actril Cold Sterilant? Actril Cold Sterilant has been extensively tested both for potential toxicological effects to the user (environmental toxicity) and to the patient (patient toxicity). Completely aldehyde free, Actril Cold Sterilant enhances worker safety and protects the environment. Actril Cold Sterilant is safe to use. Actril Cold Sterilant Environmental Toxicity Testing Test Results Acute inhalation toxicity No toxic symptoms observed Primary dermal irritation Non-irritant to skin Subchronic dermal toxicity Not dermally toxic Dermal sensitization test Not a dermal sensitizer Skin corrosion test Not corrosive to skin Primary eye irritation Corrosive to ocular tissue Acute oral toxicity LD 50 = 50 g/kg Actril Cold Sterilant Patient Toxicity Testing Test Cytotoxicity MEM agrose overlay Hemolysis in vitro test Results Non-cytotoxic at 1:1000 dilution Non-hemolytic at 500 ppm peracetic acid Peracetic acid, the main active ingredient in Actril Cold Sterilant, is not listed as a carcinogen. Page 7

Actril Cold Sterilant is aldehyde-free. Does Actril Cold Sterilant contain any aldehyde or phenol groups similar to those found in other disinfectants?

8 Actril Cold Sterilant is aldehyde-free. Does Actril Cold Sterilant contain any aldehyde or phenol groups similar to those found in other disinfectants? No, Actril Cold Sterilant is completely aldehyde- and phenol-free. Actril sterilant is also free of all chlorine compounds. Why does Actril Cold Sterilant smell like vinegar? The main active ingredient in Actril Cold Sterilant is peracetic acid, which forms through a chemical reaction between acetic acid and hydrogen peroxide. Excess acetic acid is present in Actril Cold Sterilant to ensure that adequate amounts of peracetic acid are produced. Acetic acid is the main component in vinegar. No special ventilation system is required. Are special ventilation systems required? In a safe working environment under normal use conditions, special ventilation is not required. Independent testing indicates that under normal use conditions, levels for hydrogen peroxide and acetic acid (two of the Actril components), are well below established PELs. There is no Occupational Safety and Health Administration (OSHA) permissible exposure limit (PEL) for peracetic acid, the main active ingredient in Actril Cold Sterilant. When working with any liquid chemical germicide, a safe working environment that minimizes spills and undue exposure is always recommended as standard practice. Page 8

9 How should Actril Cold Sterilant be handled? Although environmental toxicity testing indicates that Actril Cold Sterilant is a user-friendly product, it is still a liquid chemical and should be handled as stated in the Actril Directions For Use. Eye protection should always be worn since Actril Cold Sterilant is corrosive and can cause eye damage. In case of contact with eyes, flush with large amounts of water for at least fifteen (15) minutes and get prompt medical attention. Even though Actril Cold Sterilant is not a skin irritant, skin sensitizer, nor a skin corrosive, rubber gloves should be worn at all times. For a chemical emergency, spill, leak, fire, exposure, or accident, call Chemtrec, Inc., day or night, at Outside the continental U.S., call Follow Actril Directions for Use for safe handling. Does Actril Cold Sterilant require mixing, activation, or dilution? No, Actril Cold Sterilant is convenient, ready to use, and requires no mixing, activation, or dilution. How do I clean up a Actril Cold Sterilant spill? Since Actril Cold Sterilant decomposes naturally, accidental spills can be cleaned up and discarded directly down the sewer drain. No neutralization of Actril Cold Sterilant is required. Always follow the handling instructions as specified in the Actril Directions for Use. How should I dispose of Actril Cold Sterilant? Actril Cold Sterilant liquid can be disposed directly into the sewer drain. In fact, peracetic acid has been investigated as a disinfectant for sewage and sewage effluents. Peracetic acid s unique broad spectrum activity in the presence of organic matter and decomposition into natural components makes it a potentially ideal sewage treatment processing product. Actril Cold Sterilant decomposes naturally into oxygen, water, and acetic acid. How long will Actril Cold Sterilant last under normal storage conditions? Actril has a shelf-life of one year. The expiration date of Actril Cold Sterilant is printed on the front panel of the bottle label. Even upon opening the bottle, Actril Cold Sterilant will maintain its germicidal activity if not used and if re-sealed. This is because it does not require an activator like glutaraldehyde which decays after activation and must be discarded. Follow storage instructions in the Actril Directions for Use. Actril Cold Sterilant spills are easy to clean up. Actril Cold Sterilant is easy to dispose of. Page 9

10 Actril Cold Sterilant and Renalin Cold Sterilant are registered trademarks of Minntech Renal Systems. Page 10

11 References 1. Block, S.S., Ph.D., Disinfection, Sterilization, and Preservation. 4th ed. Philadelphia: Lea & Febiger; 1991, p Block, S.S., Ph.D., Disinfection, Sterilization, and Preservation. 4th ed. Philadelphia: Lea & Febiger; 1991, p [US EPA] United States Environmental Protection Agency, Office of Pesticides and Toxic Substances Re-use test protocol specifications. Page 11

12 P/N /B 2003 Minntech Corporation

Creosote. Public Health Statement for CAS# August 1996

Creosote. Public Health Statement for CAS# August 1996 Public Health Statement for Creosote CAS# 8001-58-9 August 1996 This Public Health Statement is the summary chapter from the Toxicological Profile for Creosote. It is one in a series of Public Health Statements