Medline Gemini Sterilization Wrap. Test Studies

Transcription

1 Medline Gemini Sterilization Wrap Test Studies Steam Efficacy : Steam PreVac Steam Efficacy: Steam Gravity Shelf Life: 180 Days Plasma Efficacy: STERRAD 100NX Plasma Efficacy: STERRAD NX Plasma Efficacy: STERRAD 100S Ethylene Oxide (EO) Material Strength: Ball Burst Test

2 Gemini Wrap Sterilization Studies Sterilization Efficacy: Steam PreVac, 4 Minutes Exposure, 20 Minute Dry Time Steam Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non-Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed to a Typical Health Care Mechanical Air Removal Steam Sterilization Cycle. A typical health care mechanical air removal steam cycle, target 270 F, 4 minute exposure, 20 minute dry time was microbiologically challenged with four classes of packs double wrapped in Medline Gemini disposable wrappers. These four classes consisted of the following packs. Small Textile Pack 16 OR Towels 2 GEM1130 Gemini Disposable Wrappers, 30 x 30 Large Textile Pack 48 OR Towels 2 GEM5154 Gemini Disposable Wrappers, 54 x 54 Small Instrument Pack Stainless steel instruments and parts, approximately 3 Pounds 2 GEM1130 Gemini Disposable Wrappers, 30 x 30 Large Instrument Pack Stainless steel instruments and parts, approximately 15 pounds 2 GEM5154 Gemini Disposable Wrappers, 54 x 54 Each pack was prepared with a Geobacillus stearothermophilus spore strip, approximately 1 x 10 6 spores per strip, placed either in the center of one of the stacks of OR towels in the textile packs or among the stainless instruments in the instrument packs. Additionally, all packs of each type in each cycle were monitored for internal temperature during the process by calibrated wireless temperature sensors placed within the packs. Each of the packs were processed through target 270 F, 4 minute exposure, 20 minute dry time cycles in a Steris steam sterilizer at Wuxi Apptec, Marietta, Georgia. Wuxi Apptec is an independent test laboratory that was contracted to perform the test exposures, temperature monitoring and microbiological testing.

3 Table 1 PreVac Steam Sterilization Cycle Parameters & Microbiology Test Results Physical Parameter Summary All Cycles Exposure Time Actual 4 minutes Dry/Exhaust Time Actual 22 minutes Sterilizer Temperature Target 270 F Sterilizer Temperature Range Actual F Internal Pack Temperature Range from Sensors F Microbiology Test Results Tested Pack Category Number Tested Results Small Textile Pack Sterile Small Instrument Pack Sterile Large Textile Pack Sterile Large Instrument Pack Sterile These results demonstrate that large and small packs (textile and instrument) double wrapped (nonsequentially wrapped) in Medline Gemini Disposable Wrappers can be sterilized in typical health care, mechanical air removal steam sterilization processes.

4 Gemini Wrap Sterilization Studies Sterilization Efficacy: Steam Gravity, 30 Minutes Exposure, 20 Minute Dry Time Steam Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed in a 250 F, 30 Minute Exposure Gravity Steam Sterilization Cycle A gravity steam cycle, target 250 F, 30 minute exposure, 15 minute exhaust/dry time was microbiologically challenged with four classes of packs double wrapped in Medline Gemini disposable wrappers. These four classes consisted of the following packs. Small Textile Pack 16 OR Towels 2 GEM1130 Gemini Disposable Wrappers, 30 x 30 Large Textile Pack 48 OR Towels 2 GEM5154 Gemini Disposable Wrappers, 54 x 54 Small Instrument Pack Stainless steel instruments and parts, approximately 3 Pounds 2 GEM1130 Gemini Disposable Wrappers, 30 x 30 Large Instrument Pack Stainless steel instruments and parts, approximately 15 pounds 2 GEM5154 Gemini Disposable Wrappers, 54 x 54 Each pack was prepared with a Geobacillus stearothermophilus spore strip, approximately 1 x 10 6 spores per strip, placed either in the center of one of the stacks of OR towels in the textile packs or among the stainless instruments in the instrument packs. Additionally, all packs of each type in each cycle were monitored for internal temperature during the process by calibrated wireless temperature sensors placed within the packs. Each of the packs were processed through target 250 F, 30 minute exposure, 15 minute exhaust dry time cycles in a Steris steam sterilizer at Wuxi Apptec, Marietta, Georgia. Wuxi Apptec is an independent test laboratory that was contracted to perform the test exposures, temperature monitoring and microbiological testing.

5 Table 2 Gravity Steam Sterilization Cycle Parameters & Microbiology Test Results Physical Parameter Summary All Cycles Exposure Time Actual 30 minutes Exhaust /Dry Time Actual 17 minutes Sterilizer Temperature Target 250 F Sterilizer Temperature Range Actual F Internal Pack Temperature Range from Sensors After Air Purged from Pack in Gravity Cycle F Microbiology Test Results Tested Pack Category Number Tested Results Small Textile Pack Sterile Small Instrument Pack Sterile Large Textile Pack Sterile Large Instrument Pack Sterile These results demonstrate that large and small packs (textile and instrument) double wrapped (nonsequentially wrapped) in Medline Gemini Disposable Wrappers can be sterilized in health care, gravity air removal steam sterilization processes with 30 minutes exposure time and exhaust/dry times of at least 15 minutes.

6 Gemini Wrap Sterilization Studies Shelf Life: 0, 30, 90 & 180 Days Shelf Life Evaluation for Packs Non-Sequentially Double Wrapped in Medline Gemini Disposable Wrappers and Sterilized in a Typical Mechanical Air Removal Cycle. A total of eighty (80) identically prepared textile packs in Medline Gemini disposable wrappers were sterilized in a typical health care mechanical air removal steam cycle. Each of these towel packs consisted of 16 OR towels and prepared OR towel sections wrapped in two (2) Medline GEM11136 wrappers (non-sequentially double wrapped). Each of the packs were processed through target 270 F, 4 minute exposure, 20 minute dry time cycles in a Steris steam sterilizer at Wuxi Apptec, Marietta, Georgia. Wuxi Apptec is an independent test laboratory that was contracted to perform the test exposures and microbiological testing. Upon completion of the sterilization processing, packs were placed into monitored ambient temperature storage and held for 0, 30, 90 and 180 days. At the completion of each holding time period, 20 packs were pulled and tested for sterility (by testing the OR towel sections) per USP 71 sterility test methods. 20 OR towel sections from the packs were tested in Soybean Casein Digest Broth (SCDB) and incubated for 14 days at 20 to 25 C. 20 additional sections from the packs were tested in Fluid Thioglycollate Medium (FTM) and incubated for 14 days at 30 to 35 C. Results from these studies are summarized below. Table 3 PreVac Steam Sterilization Cycle Parameters & Shelf Life Microbiology Test Results Physical Parameter Summary All Cycles and Storage Conditions Exposure Time Actual 4 minutes Dry/Exhaust Time Actual 20 minutes Sterilizer Temperature Target 270 F Sterilizer Temperature Range Actual F Storage Temperature Range Actual F Microbiology Test Results Storage Time Period OR Towel Sections Tested Results 0 Days 40 (20 SCDB + 20 FTM) 40 Sterile 30 Days 40 (20 SCDB + 20 FTM) 40 Sterile 90 Days 40 (20 SCDB + 20 FTM) 40 Sterile 180 Days 40 (20 SCDB + 20 FTM) 40 Sterile These results demonstrate that textile packs double wrapped (non-sequentially wrapped) in Medline Gemini disposable wrappers, sterilized in 270 F, 4 minute exposure, 20 minute dry time mechanical air removal steam sterilization processes and held for up to 180 days in ambient storage conditions maintained the sterility of the pack contents.

7 Gemini Wrap Sterilization Studies Sterilization Efficacy: STERRAD 100NX, STANDARD Cycle Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed to a half cycle of the STERRAD 100NX STANDARD Sterilization cycle. A full STERRAD 100NX STANDARD cycle is comprised of two identical exposure phases consisting of 6 minutes transfer, 0.5 minute diffusion and 7.5 minutes plasma. Each cycle is injected with 4.9mL of 53% nominal concentration of hydrogen peroxide as the sterilant. Test protocol followed to validate Gemini Sterilization in the STERRAD 100NX STANDARD cycle is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configurations were prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Configuration 1 10 Stainless Steel Lumens (0.7mm ID X 500mm Lg.) are placed in two STERRAD Instrument Trays (5 lumens per tray even distributed). Each stainless steel lumen in loaded with a BI and a chemical indicator is placed in each tray. Each tray is wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD Chemical Indicator Tape. Sets sterilized in a half cycle of the STERRAD 100NX STANDARD cycle. Following sterilization BI s are removed and incubated at C for 14 days. Configuration 1 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 1 was repeated with Gemini Lightweight wrap (GEM1136) with data recorded similarly. Configuration 2 Configuration 2 is the standard STERRAD 100NX Reference Load used as the control load for STERRAD validation. Configuration 2 details can be found in complete Gemini Wrap in STERRAD validation report. Configuration 2 was repeated 3 times for each of the Gemini Lightweight and Super Heavyweight wrap for complete collection of data points.

8 Table 4 Sterility Test Results, STERRAD 100NX STANDARD Cycle These results demonstrate that Gemini Wrap Products can be used in the STERRAD 100NX STANDARD cycle and will achieve sterility assurance level (SAL) of 10-6.

9 Gemini Wrap Sterilization Studies Sterilization Efficacy: STERRAD 100NX, FLEX Cycle Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed to half cycles of the FLEX Plasma Sterilization Cycle on a STERRAD 100NX. A typical FLEX Cycle on a STERRAD 100NX is comprised of two identical exposure phases consisting of 8 minutes transfer, 0.5 minute diffusion and 5 minutes exposure using 4.9mL of 53% nominal concentration of hydrogen peroxide as the sterilant. Test protocol followed to validate Gemini Sterilization in the FLEX Cycle on a STERRAD 100NX is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configurations were prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Configuration 1 Two BI s are placed at the center of two clean flexible endoscopes (one per scope). Flexible Endoscopes are then placed into two STERRAD instruments trays (one per tray). A chemical indicator strip is added to each tray and then double wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD SealSure Chemical Indicator Tape. Both sets are then sterilized in half cycles of the FLEX Plasma Sterilization Cycle. Following sterilization, BI s are removed and incubated at C for 14 days. Configuration 1 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 1 was repeated with Gemini Lightweight wrap (GEM1136) with data measured and recorded in the same manner. Configuration 2 Configuration 2 is the standard STERRAD 100NX Reference Load used as the control load for STERRAD validation. Configuration 2 details can be found in complete Gemini Wrap in STERRAD validation report. Configuration 2 was repeated 3 times for each of the Gemini Lightweight and Super Heavyweight wrap for complete collection of data points.

10 Table 5 Sterility Test Results, STERRAD 100NX FLEX Cycle These results demonstrate that Gemini Wrap Products can be used in the STERRAD 100NX FLEX cycle and will achieve sterility assurance level (SAL) of 10-6.

11 Gemini Wrap Sterilization Studies Sterilization Efficacy: STERRAD 100NX, EXPRESS Cycle Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed to half cycles of the EXPRESS Plasma Sterilization Cycle on a STERRAD 100NX. A typical EXPRESS Cycle on a STERRAD 100NX is comprised of two identical exposure phases consisting of 2.5 minutes transfer, 0.5 minute diffusion and 3.5 minutes exposure (followed by a 3 minute post processing plasma phase) using 4.9mL of 53% nominal concentration of hydrogen peroxide as the sterilant. Test protocol followed to validate Gemini Sterilization in the EXPRESS Cycle on a STERRAD 100NX is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configurations were prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Configuration 1 Two BI s are placed at the center of two clean flexible endoscopes (one per scope). Flexible Endoscopes are then placed into two STERRAD instrument trays (one per tray). A chemical indicator strip is added to each tray and then double wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD SealSure Chemical Indicator Tape. Both sets are then sterilized in half cycles of the EXPRESS Plasma Sterilization Cycle. Following sterilization, BI s are removed and incubated at C for 14 days. Configuration 1 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 1 was repeated with Gemini Lightweight wrap (GEM1136) with data measured and recorded in the same manner. Configuration 2 Configuration 2 is the standard STERRAD 100NX Reference Load used as the control load for STERRAD validation. Configuration 2 details can be found in the complete Gemini Wrap in STERRAD validation report. Configuration 2 was repeated 3 times for each of the Gemini Lightweight and Super Heavyweight wrap for complete collection of data points.

12 Table 6 Sterility Test Results, STERRAD 100NX EXPRESS Cycle These results demonstrate that Gemini Wrap Products can be used in the STERRAD 100NX EXPRESS Cycle and will achieve sterility assurance level (SAL) of 10-6.

13 Gemini Wrap Sterilization Studies Sterilization Efficacy: STERRAD NX, STANDARD Cycle Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed to a half cycle of the STERRAD NX STANDARD Sterilization cycle. A full STERRAD NX STANDARD cycle is comprised of two identical exposure phases consisting of 3 minutes transfer, 0.5 minute diffusion and 4 minutes plasma. Each cycle is injected with 1500ųL of 53% nominal concentration of hydrogen peroxide as the sterilant. Test protocol followed to validate Gemini Sterilization in the STERRAD NX STANDARD cycle is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configurations were prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Configuration 1 10 PTFE Lumens (1mm ID X 350mm Lg.) are placed into a STERRAD Instrument Tray. Each PTFE lumen in loaded with a BI and a chemical indicator is placed in the tray. Tray is wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD Chemical Indicator Tape. Sets sterilized in a half cycle of the STERRAD NX Advanced cycle. Following sterilization BI s are removed and incubated at C for 14 days. Configuration 1 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 1 was repeated with Gemini Lightweight wrap (GEM1136) with data recorded similarly. Configuration 2 Configuration 2 is the standard STERRAD NX Reference Load used as the control load for STERRAD validation. Configuration 2 details can be found in complete Gemini Wrap in STERRAD validation report. Configuration 2 was repeated 3 times for each of the Gemini Lightweight and Super Heavyweight wrap for complete collection of data points.

14 Table 7 Sterility Test Results, STERRAD NX STANDARD Cycle These results demonstrate that Gemini Wrap Products can be used in the STERRAD NX STANDARD cycle and will achieve sterility assurance level (SAL) of 10-6.

15 Gemini Wrap Sterilization Studies Sterilization Efficacy: STERRAD NX, Advanced Cycle Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and exposed to a half cycle of the Advanced cycle on a STERRAD NX. A full Advanced Cycle on a STERRAD NX is comprised of two identical exposure phases consisting of 7 minutes transfer, 0.5 minute diffusion and 4 minutes plasma exposure using 1500 ųl of 53% nominal concentration of hydrogen peroxide as the sterilant. Test protocol followed to validate Gemini Sterilization in the Advanced Cycle on a STERRAD NX is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configurations were prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Configuration 1 10 Stainless Steel Lumens (1mm ID X 500mm Lg.) are placed into a STERRAD Instrument Tray. Each stainless steel lumen in loaded with a BI and a chemical indicator is placed in the tray. Tray is wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD Chemical Indicator Tape. Sets sterilized in a half cycle of the STERRAD NX Advanced cycle. Following sterilization BI s are removed and incubated at C for 14 days. Configuration 1 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 1 was repeated with Gemini Lightweight wrap (GEM1136) with data recorded similarly. Configuration 2 A BI is placed at the center of a clean flexible endoscope. Flexible Endoscope is placed into a STERRAD instruments tray. A chemical indicator strip is added to the tray and then double wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD SealSure Chemical Indicator Tape. Set is then sterilized in a half cycle of the Advanced Plasma Sterilization Cycle. Following sterilization, BI is removed and incubated at C for 14 days. Configuration 2 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 2 was repeated with Gemini Lightweight wrap (GEM1136) with data measured and recorded in the same manner.

16 Configuration 3 Configuration 3 is the standard STERRAD NX Reference Load used as the control load for STERRAD validation. Configuration 3 details can be found in complete Gemini Wrap in STERRAD validation report. Configuration 3 was repeated 3 times for each of the Gemini Lightweight and Super Heavyweight wrap for complete collection of data points. Table 8 Sterility Test Results, STERRAD NX ADVANCED Cycle These results demonstrate that Gemini Wrap Products can be used in the STERRAD NX Advanced cycle and will achieve sterility assurance level (SAL) of 10-6.

17 Gemini Wrap Sterilization Studies Sterilization Efficacy: STERRAD 100S Standard Cycle Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and Exposed to a half cycle of the STERRAD 100S Short Sterilization cycle. A full STERRAD 100S short cycle is comprised of two identical exposure phases consisting of 6 minutes injection, 2 minute diffusion and 2 minutes plasma preceded by a 10 minute pre-exposure plasma phase. Each cycle is injected with 1440ųL of 59% nominal concentration of hydrogen peroxide as the sterilant. Test protocol followed to validate Gemini Sterilization in the STERRAD 100S Short cycle is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configurations were prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Configuration 1 10 Stainless Steel Lumens (3mm ID X 400mm Lg.) are placed in two STERRAD Instrument Trays (5 lumens per tray even distributed). Each stainless steel lumen in loaded with a BI and a chemical indicator is placed in each tray. Each tray is wrapped in Gemini Super Heavyweight wrap (GEM5136) and secured with STERRAD Chemical Indicator Tape. Sets sterilized in a half cycle of the STERRAD 100S Short cycle. Following sterilization, BI s are removed and incubated at C for 14 days. Configuration 1 test is repeated 3 times for additional data points. BI s are intermittently inspected over the 14 day incubation period. After 14 days, all BI and chemical indicator results are recorded. The above configuration 1 was repeated with Gemini Lightweight wrap (GEM1136) with data measured and recorded in the same manner. Configuration 2 Configuration 2 is the standard STERRAD 100S Reference Load used as the control load for STERRAD validation. Configuration 2 details can be found in complete Gemini Wrap in STERRAD validation report. Configuration 2 was repeated 3 times for each of the Gemini Lightweight and Super Heavyweight wrap for complete collection of data points.

18 Table 9 Sterility Test Results, STERRAD 100S STANDARD Cycle These results demonstrate that Gemini Wrap Products can be used in the STERRAD 100S Short cycle and will achieve sterility assurance level (SAL) of 10-6.

19 Sterilization Efficacy: Ethylene Oxide (EO) Sterilization Efficacy Evaluation of Packs Double-Wrapped (Non Sequentially Wrapped) in Medline Gemini Disposable Wrappers and exposed in a full cycle EO cycle. A full ethylene oxide (EO) cycle is comprised of 725 mg/l of 100% ETO, 60 minutes exposure at 55 C, 40-80% RH and with at least twelve (12) hours aeration. Test protocol followed to validate Gemini Sterilization in the Ethylene Oxide (ETO) is referenced as the overkill sterilization method in AAMI Standards and Recommended Practices - ANSI/AAMI/ISO (2009). The following configuration was prepared to test the effectiveness of sterilant penetration through the identified Gemini wrap product. Test Pack Six (6) test packs. Each test pack contained two (2) stacks of ten (10) Sterile Blue O.R. Towels (Lot# ) placed next to each other, lengthwise. A biological indicator and chemical indicator was placed in the middle of each stack. Three (3) test packs were wrapped with each model of wrap using simultaneous envelope fold per AAMI ST79. BI s were incubated and results of test BI s were negative for growth, negative controls were negative for growth, and positive controls were positive for growth. These results demonstrate that Gemini Wrap Products can be used in Ethylene Oxide (EO) and will achieve sterility assurance level (SAL) of 10-6.

20 Gemini Wrap Test Studies Material Strength: Gemini Vs. Kimberly Clark One Step Material Strength Tests were performed on both Medline Gemini Sterilization Wrap and the comparable Kimberly Clark One-Step Wrap. The product test samples listed below were tested by: Diversified Testing Laboratories Inc. 336 West Front Street Burlington, NC, (336) Lab Identification # 6018 Test Report # Date of Test: November 27, 2010 Table 10 Wrap Evaluation Sample Gemini Item # Lot # Qty One-Step Item # Lot # Qty GEM C00266LTA 12:31 10 GEM LR :39 10 GEM LR :43 10 GEM LT :07 10 GEM LT :25 10 Material Test Strength was measured using industry standard test procedure ASTM D , Bursting Strength of Knitted Goods Constant-Rate-of-Traverse (CRT), Ball Burst Test. Tests performed on Gemini Wrap were done using two sheets of single ply Gemini Wrap. Tests performed on K-C One Step were done using one sheet of the bonded two ply One Step wrap. Each sample item # was tested five times. Table 11 Wrap Stength Evaluation Test Results Gemini Item # Avg. Measurement (lbf.) One-Step Item # Avg. Measurement (lbf.) GEM GEM GEM GEM GEM Summary Per ASTM D test methodology, Medline s Gemini Wrap showed greater material strength in all comparisons.