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1 SPOR-KLENZ READY-TO-USECOLD STERILANTTECHNICAL DATA420-100-6525(01/01/10) GENERAL DESCRIPTIONSpor-Klenz Ready-To-Use (RTU) Cold Sterilant is an Environmental Protection Agency (EPA) registered product designed tobe used as a sterilant, sporicide or as a high-level disinfectant for cleanroom surfaces and equipment in the pharmaceutical,biotechnology, medical products, cosmetics and nutritionals industries. Spor-Klenz RTU sterilant may also be used in researchfacilities, including laboratory animal research RTU sterilant is a stabilized blend of peracetic acid, hydrogen peroxide and acetic acid. This chemistry providesfor fast, effective microbial control, including RTU sterilant may be used without dilution as a sterilant, sporicide or a high-level disinfectant, or it may be diluted1:50 with purified water and used as a sanitizer.

2 Spor-Klenz RTU sterilant should be used on pre-cleaned surfaces and is safefor use on stainless steel, plastics, glass, floors and walls. Please contact STERIS regarding substrate compatibility peracetic acid/hydrogen peroxide blendProvides fast microbial control against a broad range oforganisms, including bacteria, fungi, viruses andbacterial sporesReady to useSaves time; eliminates labor and the need to validatepreparation proceduresProduct may be used without dilution as a sterilant,Flexible-use options depending on facility needssporicide or as a high-level disinfectant, or it may bediluted 1:50 with purified water and used whensanitization is neededReusable as a sterilant or as a high-level disinfectantProven effective and stable for extended use(undiluted), for up to 14 days5-1/2 hour sterilant claimOne of the fastest chemical sterilants availableAvailable in 1-gal ( ), 1-qt ( ), and 55-galOffers versatile use options for both cleanrooms and(208-L) containersprocess sanitizing applicationsTYPICAL PHYSICAL pH (undiluted).

3 TypicalTypical specific gravity (77 F [25 C]).. typicalNORTH AMERICA: MICROBIAL EFFICACY DATASPORICIDAL PROPERTIESSpor-Klenz RTU sterilant is registered with the EPA as a sterilant. To be granted this registration, Spor-Klenz RTU sterilant wastested by the Association of Official Analytical Chemists (AOAC) test method , Sporicidal Activity of is a carrier method which utilizes cultures ofBacillus subtilis(ATCC 19659) andClostridium sporogenes(ATCC3584) to demonstrate efficacy. As per the test criteria, none of the 720 carriers evaluated in this test showed growth after a5-1/2 hourexposure to Spor-Klenz RTU RTU is registered with the EPA as a sporicide for use on non-porous surfaces undiluted 30 minutes at 20 C (68 F)as tested againstBacillus subtilis(ATCC 19659)and Clostridium sporogenes(ATCC 3584).

4 2 BACTERICIDAL PROPERTIESTo demonstrate that the Spor-Klenz RTU sterilant meets the EPA requirements for broad-spectrum disinfectant, AOACUse-Dilution Method was performed. This carrier method utilizesStaphylococcus aureus(ATCC 6538),Pseudomonasaeruginosa(ATCC 15442) andSalmonella enterica(ATCC 10708) to demonstrate efficacy. To satisfy the EPA requirements fora disinfectant claim, no more than one carrier per set of 60 may show growth under the test RTU sterilant is effective againstMycoplasma gallisepticum(ATCC 15302) undiluted for 10 minutes at 20 C (68 F).Spor-Klenz RTU sterilant is effective as a non-food contact surface sanitizer (Staphylococcus aureus[ATCC 6538] andKlebsiellapneumoniae[ATCC 4352]) when diluted 50x (1 part to 49 part water) for five TESTING BY EPA PROTOCOLTo demonstrate that Spor-Klenz RTU sterilant may be reused repeatedly for a 14-day period, repeated challenge testing wasperformed as specified by EPA guidelines (Re-Use Test Protocol Specifications).

5 The test protocol involves daily inoculation ofSpor-Klenz RTU sterilant with the following organisms:Bacillus subtilis(ATCC 19659), Clostridium sporogenes(ATCC 3584),Pseudomonas aeruginosa(ATCC 15442) andStaphylococcus aureus(ATCC 6538). At days 7 and 14, a portion ofSpor-Klenz RTU sterilant which had been treated in this fashion was removed and tested by the aforementioned Sporicidal andDisinfectant Testing protocols. During this testing, no failed carriers were PROPERTIESSpor-Klenz RTU sterilant is effective againstMycobacterium tuberculosis (BCG)as tested by the AOAC Tuberculocidal ActivityTest within 10 minutes at 20 C (68 F).

6 Use fresh solutions PROPERTIESSpor-Klenz RTU sterilant was found to be effective against mouse hepatitis, minute virus of mice, murine novovirus, murine parainfluenza virus type 1 (Sendai) and Human Immunodeficiency Virus (HIV-1) when tested according to EPA guidelines undilutedfor 10 minutes at 20 C (68 F) exposure. Spor-Klenz RTU sterilant was found to be effective against mouse parvovirus whentested according to EPA guildlines undiluted for 25 minutes at 20 C (68 F). Treated surfaces must remain completely immersedfor 25 PROPERTIESSpor-Klenz RTU sterilant was found to be effective againstAspergillus nigerundiluted five minutes at 20 C (68 F) SPRAYTo demonstrate that Spor-Klenz RTU sterilant is an effective disinfectant when sprayed onto a surface, the AOAC GermicidalSpray Products as disinfectants test (Method ) was performed.

7 When applied as a spray, per the testing protocol,Spor-Klenz RTU sterilant was found to be effective againstPseudomonas aeruginosa(ATCC 15442), Salmonella cholerasuis(ATCC 10708) andStaphylococcus aureus(ATCC 6538) with an exposure time of 30 seconds at 20 C (68 F).DIRECTIONS FOR USEIt is a violation of federal law to use this product in a manner inconsistent with its DisinfectantFor broad-spectrum disinfection of items such as equipment, walls, etc., remove any obvious debris or organic material fromthe surface to be disinfected. This can often be accomplished by rinsing with purified water, by mechanical action or by the useof a germicidal detergent.

8 Apply the Spor-Klenz RTU sterilant as is or as a 1:50 dilution to the clean, dry surface to be disinfectedeither by manual or mechanical means ( , spraying), in such a manner as to completely wet the surface. The surface mustremain wet for a minimum of 10 may also be desirable to completely immerse certain items in the Spor-Klenz RTU sterilant. Allowing for materials compatibilitywith the Spor-Klenz RTU sterilant formula, this is an acceptable practice with the following provisions: The items to be immersed should be free of debris and organic material prior to Spor-Klenz RTU sterilant exposure. The Spor-Klenz RTU sterilant solution may be reused for a period of up to 14 days under these SprayApply Spor-Klenz RTU sterilant undiluted onto pre-cleaned surfaces using a plastic spray bottle or other appropriate the surface to remain wet for 30 seconds.

9 Allow to air SterilantRemove any obvious debris or organic material from the surface to be sterilized. This can often be accomplished by rinsingwith water, or by detergent cleaning, followed by a water rinse. Immerse the item to be sterilized with a sufficient volume ofundiluted Spor-Klenz RTU sterilant to cover the item and fill all passages requiring sterilization. Maintain items in the sterilizingsolution for a minimum of 5-1/2 hours at 20 C (68 F) temperature. Remove items after 5-1/2 hours and rinse with sterile wateruntil effluent reaches an acceptable residue level. The solution may be used and reused for up to 14 days in a manual systemwith 5-1/2 hours only on hard, non-porous surfaces.

10 Remove any obvious debris or organic material from the surface to be sterilized. Thiscan often be accomplished by rinsing with water or by detergent cleaning followed by a water rinse. Apply product to hard,non-porous surfaces, thoroughly wetting surfaces by immersion. Treated surfaces must remainwetfor 30 minutes. Wipe dry orallow to air (non-food contact surfaces)Using water or mechanical action, remove heavy soil or gross filth from hard surfaces such as formica, stainless-steel or vinylsurfaces. Apply by cloth, mop or sponge so as to wet all surfaces thoroughly, a freshly made 50x dilution (1 part product to 49part water) of Spor-Klenz RTU sterilant, made using purified water, to the pre-cleaned surface or immerse pre-cleaned items tobe sanitized in the solution.