DUAL SPECIES BIOLOGICAL INDICATOR SPORE STRIPS For Monitoring Ethylene Oxide (EO), Steam and Chemiclave Processes

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1 DUAL SPECIES BIOLOGICAL INDICATOR SPORE STRIPS For Monitoring Ethylene Oxide (EO), Steam and Chemiclave Processes Reorder Code: STNS-65R Product Description Dual Species Biological Indicator Spore Strips for monitoring EO, Steam and Chemiclave processes consist of: A 6 mm x 30 mm strip inoculated with Bacillus atrophaeus (Cell Line 9372) population level of 10 6 and Geobacillus stearothermophilus (Cell Line 7953) population level of 10 5 Primary packaging in a glassine pouch Indications for Use The Spore Strips may be utilized to monitor EO, Steam and Chemiclave sterilization process efficacy in healthcare and industrial applications. The following indications for use have been cleared by the US FDA under 510(k) K113221: Steam: 121 C gravity displacement for 30 minutes EO: 600 mg/l, 60% RH at 55 C for 2 hours and 10 minutes The following indications for use have been cleared by the US FDA under 510(k) : Chemiclave: 132 C for 20 minutes in a MDT Harvey Chemiclave model EC5500 Chemiclave sterilizer Instructions for Use Place Spore Strips (a minimum of 10 per exposure is recommended) inside representative materials to be sterilized or within the chamber directly. Package or wrap product as usual, if applicable. Locate the test packages or Spore Strips in areas most difficult to sterilize, as outlined in your specific sterilization validation protocol (usually four corners front, four corners rear, center-center and center-top) or according to standard operating procedure. Run the cycle. After sterilization or exposure, remove Spore Strips or product from sterilizer. Spore Strips may be held at room temperature conditions for up to 96 hours post-exposure prior to transfer without any impact to the performance. If the processed Spore Strips are not transferred to growth medium within 96 hours of exposure, discard the strips and reprocess the sterilization load. Aseptically remove the Spore Strip from the primary packaging and transfer to ml of Soybean Casein Digest Broth (SCDB) for the standard seven day incubation period. Conversely, modified growth medium, NAMSA code GMBCP-100, may be utilized in place of the standard SCDB Rev North American Science Associates, Inc. Page 1 of 5

2 for Geobacillus stearothermophilus where a reduced incubation period is desired. This exact media composition must be utilized in conjunction with BI Spore Strips exposed to steam or chemiclave sterilization processes in order to reduce the incubation period from the standard seven day incubation period. Contact NAMSA for further guidance. Transfer one Spore Strip which has not been exposed in a sterilization process as a Positive Control. Incubation: Incubate the cultured Spore Strips and the Positive Control as outlined in the following table: Organism Process Incubation Temperature Media Type Minimum Incubation Period B. atrophaeus EO C Standard SCDB 7 days Steam or Chemiclave C Standard SCDB 7 days G. stearothermophilus Steam C GMBCP hours Chemiclave C GMBCP hours Monitoring: Examine the tubes for growth daily and determine the number of positives for each cycle. Remove positive cultures from incubation and discard upon detection and documentation of results. Interpretation: Organism Media Type Growth Characteristic B. atrophaeus Standard SCDB Turbid with orange-colored pellicle G. stearothermophilus Standard SCDB GMBCP-100 Turbid with cream-colored sediment Color shift from purple to yellow and/or turbidity Tubes of standard SCDB which remain clear and without growth are considered negative for growth. Tubes of modified media, NAMSA Code GMBCP-100, which maintain the color purple and do not demonstrate turbidity are considered negative for growth. For unexpected positives, it is recommended that a Gram stain be performed. Gram positive rods are indicative for the indicator organism. If a positive is observed, repeat the procedure, placing several BIs throughout the sterilizer. If a positive result is observed again, review process (exposure temperature and time) and investigate for sterilizer malfunction. Positive Control: The Positive Control Spore Strip should demonstrate growth as outlined in the table above. If the Positive Control does not result in growth, the exposure is considered invalid. Check the conditions during incubation and verify the capability of the medium to support growth. Rev North American Science Associates, Inc. Page 2 of 5

3 Monitoring Frequency For greatest control of sterilized goods it is recommended that a minimum of ten (10) Spore Strips be included with every load. Physical Properties Process Strip Dimension Glassine Dimension Packaging EO, Steam and Chemiclave 6 mm x 30 mm 25 mm x 75 mm 100/Box Performance Characteristics Population Purity EO Resistance B. atrophaeus: 1.0 to 6.0 x 10 6 per strip G. stearothermophilus 1.0 to 6.0 x 10 5 per strip No evidence of contamination present in sufficient numbers to adversely affect the finished product. D value at 54 C ± 1 C, 600 mg/l ± 30 mg/l, 60% RH ± 10% RH 2.5 to 5.8 minutes The EO D value range is based on the requirements outlined in the USP and ISO The EO D value is determined using 100% EO. NAMSA switched from Oxyfume 2002 to 100% EO in 2010 in accordance with the EPA s Final Rule regarding use of hydrochlorofluorocarbons (HCFCs), including HCFC-22, the key component of Oxyfume gas blends. Survival Kill Times Calculated based on the formulations outlined in the USP, ISO and guidance issued by the FDA. Rev North American Science Associates, Inc. Page 3 of 5

4 D value at 121 C ± 0.5 C 1.5 to 3.0 minutes The Steam D value range is based on the requirements outlined in the USP, ISO and guidance issued by the Food & Drug Administration (FDA). Steam Resistance Survival Kill Times Calculated based on the formulations outlined in the USP, ISO and guidance issued by the FDA. z value 6 C Determined based on three temperatures in the range of 115 C to 130 C. NAMSA typically utilizes D values determined at 119 C, 121 C and 130 C for z value calculation. Determined at 132 C ± 2.5 C Chemiclave Resistance Survival Time: 5 minutes Kill Time: 15 minutes Population: 50% to 300% of certified population Post-Market Criteria D value: ± 20% of the certified D value Survival Time: All Spore Strips result in growth at the certified survival time Kill Time: All Spore Strips result in no growth at the certified kill time Compliance ISO Sterilization of health care products Biological indicators Part 1: General requirements ISO Sterilization of health care products Biological indicators Part 2: Biological indicators for moist heat ethylene oxide processes ISO Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes USP <1035> Biological Indicators for Sterilization USP <55> Biological Indicators Resistance Performance Tests NAMSA has a validated method for Total Viable Spore Count. Please inquire for the Technical Bulletin entitled Population Verification for Biological Indicator Strips to ensure consistent methodologies are being utilized when performing verification testing. USP Biological/Official Monographs Rev North American Science Associates, Inc. Page 4 of 5

5 Storage and Shelf Life 15 C to 30 C Protect from heat and radioactive sources 30% to 80% Relative Humidity Shelf Life 30 Months from the date of manufacture Short excursions outside the range of temperature and relative humidity recommended will not impact the performance of the Spore Strips. Do not use damaged Spore Strips. Do not use after the expiration date. The Spore Strips contain live cultures and should be handled with care. Disposal Autoclave for not less than 30 minutes at 121ºC or per other validated disposal cycle prior to discard. Rev North American Science Associates, Inc. Page 5 of 5