Medline Gemini Sterilization Wrap. Test Studies
|
|
- Laurence Charles
- 6 years ago
- Views:
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.
REUSABLE MEDICAL DEVICE VALIDATION
All sterilization processes require validation of the efficacy and reproducibility of the process. Depending on the type of sterilization, this may be accomplished by partial, sub-lethal, or repetitive
More informationQuality Control LOAD CONTROL. VERIFY Load Control Products. Use to monitor and release instrumentation with confidence RECORD KEEPING & LABELING
STERILITY ASSURANCE Use to monitor and release instrumentation with confidence VERIFY Load Control Products LOAD CONTROL PROCESS CONTROL PACK CONTROL EQUIPMENT CONTROL RECORD KEEPING & LABELING PRODUCT
More informationDUAL SPECIES BIOLOGICAL INDICATOR SPORE STRIPS For Monitoring Ethylene Oxide (EO), Steam and Chemiclave Processes
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
More informationSTERILIZATION VALIDATION IN THIS SECTION REPROCESSING VALIDATIONS FOR REUSABLE MEDICAL DEVICES. Radiation Sterilization Validation
STERILIZATION VALIDATION All sterilization processes require validation of the efficacy and reproducibility of the process. Depending on the type of sterilization, this may be accomplished by partial,
More informationTEST CODE DEFINITION STERRAD H202. Test Code Test Name Testing Description. Cycle. Efficacy. SE-200 STERRAD 200 Efficacy. Cycle. STD Cycle Efficacy
Code Name ing Description MC-100S SE-100S STERRAD 100S STERRAD 100S TEST CODE DEFINITION STERRAD H202 125 Highpower Road. Rochester, NY 14623 (888) -722-1529 www.highpowervtls.com Materials Compatibility
More informationInstructions for Validation of Autoclaves
Instructions for Validation of Autoclaves A. Validation of autoclaves may accomplished by the following methods: 1. Autoclave tape applied to the outside of all packs to validate that the correct temperature
More informationObjectives. The Perioperative Nurse s Role 6/24/2016. Instrument Processing & Sterilization Chesapeake Perioperative Consortium 2016
Instrument Processing & Sterilization Chesapeake Perioperative Consortium 2016 Ensuring our patients get clean, sterile instruments every time. Objectives Define the perioperative nurse and surgical tech
More informationPutting Confidence in Your Hands.
Putting Confidence in Your Hands. 3M Sterilization Products and Services Full Line Catalogue 1 Trusted 3M Sterilization Solutions Equipment Monitoring Exposure Monitoring Pack Monitoring Load Monitoring
More informationQuality Control EQUIPMENT CONTROL. Monitor critical performance characteristics of sterilization, decontamination or cleaning equipment
STERILITY ASSURANCE Monitor critical performance characteristics of sterilization, decontamination or cleaning equipment VERIFY Equipment Control Products EQUIPMENT CONTROL LOAD CONTROL PROCESS CONTROL
More information6 Handling, collection, and transport of contaminated items General rationale Separation of waste and reusable items at point of
Contents Glossary of equivalent standards... ix Committee representation... xi Acknowledgments...xiii Foreword... xiv Introduction: Need for the recommended practice...1 1 Scope...5 1.1 General...5 1.2
More information6 Handling, collection, and transport of contaminated items General rationale Separation of waste and reusable items at point of
Contents Glossary of equivalent standards... ix Committee representation... xi Acknowledgments...xiii Background on Amendment 1...xiii Foreword... xiv Introduction: Need for the recommended practice...1
More informationBest Practice Monitoring for Sterile Processing Professionals
Best Practice Monitoring for Sterile Processing Professionals Sterile processing departments are faced with greater challenges than ever. Increasing demands for quick turnarounds. Pressure to streamline
More informationNEW Faster, more versatile!
NEW Faster, more versatile! > 35min flexible cycle > Process Single Channel surgical flexible endoscopes > Process Dual Channel surgical flexible endoscopes > Process 10.89 kg of Load including 1 surgical
More informationPackaging & Sterilization
Packaging & Sterilization Packaging & Sterilization 1 Dr. Norman Clinical Consultant General Sterilization Packaging System in Hospitals Sterilization Packaging System Disposable Reusable Crepe paper Woven
More information8/27/2015. Learning Objectives. Purpose of Sterilization. To destroy all living pathogenic microorganisms
Learning Objectives Compare and contrast the available methods of sterilization for the healthcare setting Describe the appropriate use and monitoring for sterilization methods Purpose of Sterilization
More informationResponses to Questions for SYSTEM 1E Process Monitoring and Validation Webinar
Responses to Questions for SYSTEM 1E Process Monitoring and Validation Webinar MONITORING THE SYSTEM 1E PROCESSOR Q: I want to confirm that there is no need for a Biological Indicator (BI) and that use
More informationBiological Monitoring
Biological Monitoring Prof. Duygu PERÇİN, MD Department of Clinical Microbiology Erciyes University Faculty of Medicine, Kayseri-TURKEY duygu.percin@hotmail.com Learning Objectives The attandee will be
More informationgke Steri-Record Testsets and PCDs for validation, process and batch monitoring of sterilization processes
gke Steri-Record Testsets and PCDs for validation, process and batch monitoring of sterilization processes Application Process Monitoring Systems (PMS) are process challenge devices that are used to test
More informationWhat is happening inside that magic box? Fundamentals of vaporized hydrogen peroxide sterilization in health care facilities
SM What is happening inside that magic box? Fundamentals of vaporized hydrogen peroxide sterilization in health care facilities September 20, 2017 APIC, New York, New York Disclosure Judy Lambert BS, CSPDT
More informationANSI/AAMI ST79 A2:2009 Key Changes in the 2009 Amendment
3M Attest TM TM Products Sterile U Network T U T O R I A L S ANSI/AAMI ST79 A2:2009 Key Changes in the 2009 Amendment Background: A second amendment (A2:2009) to the Association for the Advancement of
More informationInfection Control. Low Temperature Sterilization (LTS) Critical Aspects on Selection and Validation of LTS-Processes
Infection Control Low Temperature Sterilization (LTS) Critical Aspects on Selection and Validation of LTS-Processes Dr. Tronje von dem Hagen tronje@vondemhagen.com Lübeck (Germany) T. v. dem Hagen, Lübeck/Germany
More informationNO 2 Gas Sterilization and Decontamination: Keeping Pace, from Start to Finish
NO 2 Gas Sterilization and Decontamination: Keeping Pace, from Start to Finish Evan Goulet, Ph.D., VP of Microbiology Applications Laboratory PDA Midwest: Sterility Assurance and Risk Mitigation October
More informationTechnical Data Monograph. VERIFY Assert Self-Contained Biological Indicators and VERIFY Assert STEAM Process Challenge Devices
Technical Data Monograph VERIFY Assert Self-Contained Biological Indicators and VERIFY Assert STEAM Process Challenge Devices Table of Contents 1. Introduction....3 2. Product Use Application...4 Device
More informationTHE TERMS VALIDATION AND VERIFICATION ARE FREQUENTLY
Lesson No. CRCST 162 (Technical Continuing Education - TCE) Sponsored by: by Susan Klacik, BS, CRCST, ACE, CIS, FCS IAHCSMM Clinical Educator Validation and Verification LEARNING OBJECTIVES 1. Describe
More informationTesting of routinely sterilized products should
Product Quality Assurance Testing: One Hospital s Experience Testing of routinely sterilized products should be part of a healthcare facility s quality control program, and ANSI/AAMI ST79:2006, Comprehensive
More informationFAQFrequently. Asked Questions. Education & Training. 3M Sterilization Assurance Techline
Asked Questions 3M Sterilization Assurance Techline by Sandra Velte, BA, CSPDT FAQFrequently Objectives After completion of this self-study activity, the learner will be able to: 1. Develop a policy and
More informationYour Sterile Processing Partner. Duraholder IPS
Your Sterile Processing Partner The Bioseal Duraholder Instrument Protection System (IPS) was designed by a leading university hospital to prevent costly damage to their delicate neuro instruments. After
More information3M Life Science Sterilization Product Portfolio More control. More confidence.
3M Life Science Sterilization Product Portfolio More control. More confidence. Solutions for medical device and pharmaceutical sterilization processes 3M Life Science Sterilization Product Portfolio Setting
More informationNEW Faster, more versatile!
NEW Faster, more versatile! > 35min flexible cycle > Process Single Channel surgical flexible endoscopes > Process Dual Channel surgical flexible endoscopes > Process 10.89 kg of Load Plus 1 surgical flexible
More informationTIP-GUARD INSTRUMENT PROTECTORS. Products Designed and Manufactured by the Scanlan Family Since 1921
TIP-GUARD Products Designed and Manufactured by the Scanlan Family Since 1921 TIP-GUARD Ensuring safe, cost-effective protection of blade tips and edges for all surgical instrumentation. Designed to eliminate
More informationEffective Heat Sterilization in CO 2 Incubators
Effective Heat Sterilization in CO 2 Incubators Volume 4, Number 3 Key Words Key Words Class 100 air Contamination control Contamination elimination HEPA filtration Incubator Heat Sterilization White Paper
More informationRev. 1 May 2018 Terragene offers a range of effective and easy-to-handle products to control the washing, hygiene, disinfection and sterilization processes in medical diagnostic laboratories. Available
More informationSterilization Policy. Georgia Regents Medical Center Policy Library. Policy Owner: Epidemiology POLICY STATEMENT
POLICY STATEMENT The ability to sterilize instruments and equipment for use during operative or other invasive procedures is critical to promoting successful patient outcomes and preventing infections.
More informationsterilisation monitoring products
sterilisation monitoring products Known for their consistent, reliable performance, Excelsior Scientific sterilisation monitoring products are used by pharmaceutical and medical device manufacturers, contract
More informationTECHNICAL DATASHEET. in compliance with: USP, ISO and all appropriate subsections FQ 106 v3.0 August, 2015
ETIGAM TECHNICAL DATASHEET ETIGAM NSS biological indicator spore strips for radiation Bacillus pumilus This technical report provides relevant data and instructions for use of the NSS biological indicator
More informationYour Sterile Processing Partner. Duraholder IPS
Your Sterile Processing Partner Table of Contents Item Page Duraholder Case Study 17 AAMI ST79 Reference 20 Steam Sterilization Efficacy Testing 21 PRODUCT INDEX Product Page Standard Pouches DURA050/100
More informationWritten By Dr. Robert Ramaley (Univ. NE Med CTR), Mia Ware, Dan Pearson, and Christopher R. Dwyer* (Raven Biological Laboratories)
Performance Comparison for Three Types of Biological Indicators Used in Steam Sterilization Processes: Spore Strips, Crushable Self-contained, and Sealed Glass Ampoule Written By Dr. Robert Ramaley (Univ.
More informationThe inaugural use of vaporized
Lesson No. CRCST 164 (Technical Continuing Education - TCE) Sponsored by: Vaporized Hydrogen Peroxide Sterilization BY LARRY TALAPA, BS, MS, CQE - MICROBIOLOGIST AND TECHNICAL SERVICE SPECIALIST, 3M HEALTH
More informationIN THIS SECTION MICROBIOLOGY TESTING EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT. Bacterial Endotoxin (LAL) Testing
EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT IN THIS SECTION MICROBIOLOGY TESTING Microbial assays involve a variety of tests, from the determination of the numbers and types of organisms naturally present
More informationSpecialty Testing of Steam Sterilizers
Specialty Testing of Steam Sterilizers Nancy Chobin, RN, AAS, ACSP, CSPM, CFER 2017 Sterile Processing University, LLC. **This in-service has been Approved by the CBSPD for 1.5 CEUs. Objectives 1. To describe
More informationSterilization & Chemical Resistance of Healthcare Polymers
Sterilization & Chemical Resistance of Healthcare Polymers Key Terms & Definitions Sterilization - A process that eliminates or kills all forms of life, including transmissible agents, on a medical device;
More informationThe inaugural use of vaporized
Lesson No. CRCST 164 (Technical Continuing Education - TCE) Sponsored by: Vaporized Hydrogen Peroxide Sterilization BY LARRY TALAPA, BS, MS, CQE - MICROBIOLOGIST AND TECHNICAL SERVICE SPECIALIST, 3M HEALTH
More informationEvery Step. Every Detail.
3M Sterilization Products and Services Every Step. Every Detail. Every Day. 1 2 3 4 3M Sterilization: Comprehensive Monitoring Portfolio World Class Technical Support Expert Sales Support 3M Attest Sterile
More informationValidating reusable medical and dental devices for over 30 years
Validating reusable medical and dental devices for over 30 years TABLE OF CONTENTS About Us 2 History Who We Are Today 3 Site Visits/Audits Certifications/Quality GLP/GMP Contact Us Protocols & Procedures
More informationSterilization - validation, qualification requirements. Sterilization - Overview
Sterilization - validation, qualification requirements Dawn Tavalsky 1 ISPE Boston Chapter Framingham MA 19Sep2013 Sterilization - Overview Objectives Discuss definition of Sterile Briefly describe sterilization
More informationSafe Operating Procedure
Safe Operating Procedure (Revised 8/12) AUTOCLAVE OPERATION AND PERFORMANCE TESTING (For assistance, please contact EHS at (402) 472-4925, or visit our web site at http://ehs.unl.edu/) Autoclaves are used
More informationTHE BASICS OF STERILIZATION
THE BASICS OF STERILIZATION Objectives State the importance of sterilization to patient care Review three key essentials of the sterilization process Describe sterilization methods used, application, limitations,
More informationRaven Labs. Sterility Assurance for Industry. Sterility Assurance Products Since A division of Mesa Laboratories, Inc.
Raven Labs A division of Mesa Laboratories, Inc. Sterility Assurance for Industry Sterility Assurance Products Since 1949 Industrial Use Biological Indicators Most co mmercially available Biologi cal Indicators
More informationMcKesson Sterilization Products
McKesson Sterilization Products Table of Contents Introduction Introduction... 3 Biological Indicators and Incubators Steam Integrator... 4 Sterilization Biological Indicator Vial...4 Self-Contained Biological
More informationThey can be used on washer-disinfectors, ultrasonic cleaners, surgical instruments and endoscopes. Page 5
Rev. 0 October 2017 Terragene offers a wide range of simple and effective products to precisely control the washing, hygiene and sterilization processes in veterinary clinics. Available in a variety of
More informationSecure. Tested. Certified.
Secure. Tested. Certified. We solve problems with confidence and creativity. Monitoring Products for Dry Heat DRY Steam-Formaldehyde Chlorine Dioxide FORM CL02 NAMSA s Sterilization Products Division manufactures
More information8/23/2012. Continuing Education Contact Hours. How much of your formal education focused on sterilization or sterile processing?
Continuing Education Contact Hours The presenter is an employee of STERIS Corporation and receives no direct compensation other than normal salary for participation in this activity. STERIS Corporation
More informationSlide 1. Slide 2. Slide 3. Sponsored by Webber Training Inc. For more information contact Paul Webber
Slide 1 QUALITY ASSURANCE IN STERILIZATION Susan Hadfield Director, Sterile Processing Department Health Sciences Centre Winnipeg, Manitoba Hosted by Paul Webber (paul@webbertraining.com) A teleclass sponsored
More informationHygiene Monitoring. Biological Indicators for Monitoring Sterilization Processes. Product Information. BI_07_en
Hygiene Monitoring Biological Indicators for Monitoring Sterilization Processes Product Information BI_07_en BAG-BioStrip Biological Indicators for Monitoring all Types of Sterilization Processes STEAM
More informationQUALITY ASSURANCE IN AN MDRD
QUALITY ASSURANCE IN AN MDRD MAINTENANCE AND PREVENTATIVE MAINTENANCE MDRD is a machine dependent department washers, pasteurizers, cart washer, sterilizer, ultrasonic, heat sealers, RO water systems All
More informationConsistent. Reliable. Innovative.
Consistent. Reliable. Innovative. Your most trusted partner for sterilization products and services. Monitoring Products for Steam Sterilization NAMSA s Sterilization Products Division manufactures and
More informationSterilisation Monitoring Products
Sterilisation Monitoring Products Known for their consistent, reliable performance, Excelsior sterilisation monitoring products are used by pharmaceutical and medical device manufacturers, contract sterilisers,
More informationCool when it counts. 3M Steri-Vac Sterilizer/Aerator GS Series. For Health Care Facilities
Cool when it counts 3M Steri-Vac Sterilizer/Aerator GS Series For Health Care Facilities Stay cool under pressure with state of the art temperature and humidity monitoring and a touch screen cycle display
More informationCAN STERILE REALLY BE STERILE?: EFFECTIVE AUTOCLAVING METHODS
Vet Times The website for the veterinary profession https://www.vettimes.co.uk CAN STERILE REALLY BE STERILE?: EFFECTIVE AUTOCLAVING METHODS Author : James Gasson Categories : Vets Date : February 2, 2009
More informationAesculap SterilContainer System Instructions for Use Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities
Aesculap SterilContainer System Instructions for Use Steam, Ethylene Oxide and Vapor Hydrogen Peroxide Sterilization Modalities Instructions for Use As of June 2016 Blank Page Table of Contents CHAPTER
More informationBiological Indicators and Their Application in Clinical Sterilization Spores Don t Lie 1
Biological Indicators and Their Application in Clinical Sterilization 2010 Spores Don t Lie 1 SGM Biotech, Inc. 10 Evergreen Drive, Suite E Bozeman, MT 59715 Tel: 406-585-9535 Fax: 406-585-9219 email:
More information2. Describe correct actions to take to address sterilization process failures. 3. List possible causes of sterilization process failures.
Objectives 1. Discuss the importance of sterilization process monitoring. 2. Describe correct actions to take to address sterilization process failures. 3. List possible causes of sterilization process
More informationFacility: Sterile Processing Assessment Date: CRITERIA ANSI/AAMI COMPLIANT Number Y N N/A Point of Use Gross contaminant is removed with
Point of Use 6.2-6.3 Gross contaminant is removed with water Instruments are sorted Sharps removed Instruments placed back in original container Un-used instruments placed in bottom of basket Towel placed
More information3M Products and Services for Medical Sterilization Processes. Full Line Catalog. Medical
3M Products and Services for Medical Sterilization Processes Full Line Catalog Medical 3M Medical Sterilization Specialties 3M Medical Sterilization Specialties is a global leader in the manufacture and
More informationLow temperature sterilization with hydrogen peroxide vapour; V-PRO TM applications & best practice
1 Low temperature sterilization with hydrogen peroxide vapour; V-PRO TM applications & best practice Dr. Georgia Alevizopoulou MD Senior Manager, Clinical Education STERIS Infection Prevention Technologies
More informationHyperGrip Series Product Sterilization White Paper
HyperGrip Series Product Sterilization White Paper 1 Contents 3 HyperGrip (HG) Series Product Sterilization 4 Autoclaving 4 EtO Sterilization 4 Sterrad 5 Tests on HyperGrip Connectors 6 Autoclave Sterilization
More informationCompetency Guide: Care and Handling of Rigid Endoscopes
Competency Guide: Care and Handling of Rigid Endoscopes This document details the basic steps to correctly process and maintain a rigid endoscope. This document can be used to perform a competency review
More informationNovember 18, Andersen Sterilizers, Inc. Dr. William Andersen President 3154 Caroline Drive Haw River, North Carolina 27258
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 18, 2015 Andersen
More informationTechnical Data Monograph. VERIFY All-In-One STEAM Reusable Test Pack
Technical Data Monograph VERIFY All-In-One STEAM Reusable Test Pack Table of Contents 1. Introduction...3 2. Product....3 Use Application...3 Device Description...3 VERIFY All-In-One STEAM Reusable Test
More informationLow Temperature Processing. An Update on Guidelines, Standards and Requirements
Low Temperature Processing An Update on Guidelines, Standards and Requirements Continuing Education Contact Hours Participants must complete the entire presentation/seminar to achieve successful completion
More informationapplying a unique combination of disciplines consulting, preclinical, toxicology,
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA's MRO Approach
More informationDisinfection & Sterilization
Disinfection & Sterilization Objectives Define important components in cleaning, disinfection, and sterilization Identify methods for cleaning, disinfection, or sterilization List risks of failure to properly
More information( 주 ) 세현테크 TEL : FAX :
All products manufactured by Mesa are done so in accordance with current Quality System Regulations of the United States Food and Drug Administration and meet the standards established by USP and ISO 11138.
More informationSterile Barrier Systems. Critical to Quality Issues: Packaging & Product Sterility. John B. Kowalski, Ph.D. Principal Consultant
Sterile Barrier Systems Critical to Quality Issues: Packaging & Product Sterility John B. Kowalski, Ph.D. Principal Consultant March 6-8, 2012 Perspective The Ultimate Customer for a Sterile Medical Product
More informationIdeal Sterilization Method. Sterilization. Sterilization Practices in Healthcare Facilities
Sterilization Practices in Healthcare Facilities Virtual Tour of Central Processing William A. Rutala, Ph.D., M.P.H. Director, Hospital Epidemiology, Occupational Health and Safety Program, UNC Health
More informationNitrogen Dioxide (NO 2 ) PDA: A Global. Sterilization and. Association. Decontamination Systems. November 4, PDA Europe Parenterals 2014
Nitrogen Dioxide (NO 2 ) PDA: A Global Sterilization and Association Decontamination Systems November 4, 2014 PDA Europe Parenterals 2014 Objectives Review NO 2 processes Sterilization Decontamination
More informationLow temperature sterilizer Getinge STERIZONE VP4
Low temperature sterilizer Getinge STERIZONE VP4 The new standard of low temperature sterilization This document is intended to provide information to an international audience outside of the US. Innovation
More informationPackaging Systems for Central Service Operations
Lesson No. CRCST 132 (Technical Continuing Education - TCE) Sponsored by: by Carol Petro, RN, CRCST, CIS, CNOR OR Educator and Sterile Processing Educator Indiana University Health North Hospital Carmel,
More informationSterilization, disinfection and reprocessing
Sterilization, disinfection and reprocessing David R. Woodard, MSc, CIC, FSHEA Definitions Cleaning the removal of visible soil from the surfaces, joints and lumen of instruments or devices. This is done
More information3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT
3M Sterile U Sterilization Assurance Continuing Education 3M s Sterilization Tech Line FAQs Sandra Velte, BA, CSPDT May 2013 Objectives After completion of this self-study activity, the learner will be
More informationPRODUCT D-VALUE STUDIES: A CRITICAL TOOL WHEN DEVELOPING A STERILIZATION PROCESS
Volume 1, Number 3 June 2004 PRODUCT D-VALUE STUDIES: A CRITICAL TOOL WHEN DEVELOPING A STERILIZATION PROCESS Kurt McCauley R & D Lab Manager The objective of a sterilization process is to kill the naturally
More informationPACKAGE TESTING & VALIDATION IN THIS SECTION EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT
EXPERT SOLUTIONS FOR PRODUCT DEVELOPMENT PACKAGE TESTING & VALIDATION A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary
More informationEffect of Storage Conditions upon the Resistance (D-value) of Spore Strip Biological Indicators (BIs) used in EtO Sterilization Monitoring
Effect of Storage Conditions upon the Resistance (D-value) of Spore Strip Biological Indicators (BIs) used in EtO Sterilization Monitoring Wendy Royalty*, Mia Ware, Russell Nyberg Raven Biological Laboratories,
More information3/26/2014 SPAULDING CLASSIFICATION OBJECTIVES PRINCIPLES OF DISINFECTION AND STERILIZATION IN THE DENTAL SETTING PROCESSING SEMI CRITICAL OBJECTS
Module F OBJECTIVES State the principles of disinfection and sterilization PRINCIPLES OF DISINFECTION AND STERILIZATION IN THE DENTAL SETTING List the current methods for disinfection and sterilization
More informationPRINCIPLES OF DISINFECTION AND STERILIZATION IN THE DENTAL SETTING OBJECTIVES
Module F PRINCIPLES OF DISINFECTION AND STERILIZATION IN THE DENTAL SETTING OBJECTIVES State the principles of disinfection and sterilization List the current methods for disinfection and sterilization
More informationSterilAmp II Geobacillus stearothermophilus
SterilAmp II Geobacillus stearothermophilus TECHNICAL REPORT Complies to USP, ISO 11138, and all appropriate subsections Technical Data and Use of SterilAmp II Part #7709 Rev.5 25FEB14 Page 1 of 6 INTRODUCTION
More informationTechnical Data Monograph. STERIS VHP LTS-V - Low Temperature Surfaces Terminal Sterilization
Technical Data Monograph STERIS VHP LTS-V - Low Temperature Surfaces Terminal Sterilization STERIS VHP LTS-V Low Temperature Surfaces Terminal Sterilization Table of Contents 1. Abstract 3 2. VHP LTS-V
More informationCompounding Pharmacies and the USP <71> Sterility Tests
Compounding Pharmacies and the USP Sterility Tests Scott Sutton, Ph.D. scott.sutton@microbiol.org 49 41 Disclaimer I am making this presentation as an independent agent I am not making this presentation
More informationGlobal Sterilization Equipment Market: Trends & Opportunities ( )
Global Sterilization Equipment Market: Trends & Opportunities (2012-2017) Executive Summary Sterilization is imperative to infection control procedure due to which it has gained significant importance
More informationPACKAGE TESTING AND VALIDATION SERVICES
PACKAGE TESTING AND VALIDATION SERVICES A sterile medical device, which includes the packaging, must function as labeled for the shelf-life claimed for the device. The primary package must maintain its
More informationENVIRONMENTAL HEALTH & SAFETY
ENVIRONMENTAL HEALTH & SAFETY Standard Operating Procedures for Safe Autoclave Operations The purpose of this document is to provide standard operating procedures for the safe use of autoclaves. Autoclaving
More informationSecure. Tested. Certified.
Secure. Tested. Certified. We solve problems with confidence and creativity. Monitoring Products for Dry Heat Steam-Formaldehyde FORM Chlorine Dioxide Table of Contents Crosstex Industrial is a division
More informationDart Technical Bulletin. Evaluation of the Daily Air Removal Test (Dart) August 7, 1985
Dart Technical Bulletin Evaluation of the Daily Air Removal Test (Dart) August 7, 1985 SUMMARY The data presented in this report show that Dart (Daily Air Removal Test) detects air at the same leak rate
More informationPRODUCT CATALOGUE. for gke Steri-Record Biological Indicators, Process Challenge Devices and Accessories
PRODUCT CATALOGUE for gke Steri-Record Biological Indicators, Process Challenge Devices and Accessories Spore strips, Ampoules, Suspensions, Self-contained Mini-Bio-Plus Indicators to monitor steam, formaldehyde,
More informationPRODUCT CATALOGUE. for gke Steri-Record Biological Indicators, Process Challenge Devices and Accessories
PRODUCT CATALOGUE for gke Steri-Record Biological Indicators, Process Challenge Devices and Accessories Spore strips, Ampoules, Suspensions, Self-contained Mini-Bio-Plus Indicators to monitor steam, formaldehyde,
More informationHygiene Monitoring. Chemical Indicators, BD-Test and Batch- Product Information. CI_01_Eng
Hygiene Monitoring Chemical Indicators, BD-Test and Batch- Control (PCD) Product Information CI_01_Eng verkauf@bag-healthcare.com service@bag-healthcare.com BAG-BD-Check II / BAG-BD-Check Disposable Bowie
More informationPRODUCT CATALOGUE. for gke Steri-Record and gke Clean-Record Chemical indicators, PCDs and accessories for cleaning and sterilization
PRODUCT CATALOGUE for gke Steri-Record and gke Clean-Record Chemical indicators, PCDs and accessories for cleaning and sterilization Bowie-Dick Simulation Test Batch and Process Monitoring Systems, Documentation
More information3034 Owen Drive Antioch, TN USA Fax: Maybachstraße 10. Revised 01/17
CLN VersaPak Modular Instrument Tray Symmetry Surgical Inc. 3034 Owen Drive Antioch, TN 37013 USA 1-800-251-3000 Fax: 1-615-964-5566 www.symmetrysurgical.com EC REP Symmetry Surgical GmbH 78532 Tuttlingen,
More informationMethod Suitability Report Membrane Filtration Sterility Test with QTMicro Apparatus
Method Suitability Report Membrane Filtration Sterility Test with QTMicro Apparatus Bevacizumab (Avastin) 1.25 mg/0.05ml This report provides details on the specifics of a Membrane Filtration Sterility
More informationAdvantages. Steam sterilization
Rev. 1 November 2016 Steam sterilization Sterilization is the total destruction of all microorganisms, whether or not pathogenic, and their spores. Moist heat in the form of saturated steam under pressure
More information