8/27/2015. Learning Objectives. Purpose of Sterilization. To destroy all living pathogenic microorganisms

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1 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 To destroy all living pathogenic microorganisms 1

Patient Contact Examples Device Classification Minimum Inactivation Level Intact skin Non-Critical Cleaning and/or Low/Intermediate /High Level Disinfection Mucous membranes or

Patient Contact Examples Device Classification Minimum Inactivation Level Intact skin Non-Critical Cleaning and/or Low/Intermediate Level Disinfection Mucous membranes or

2 Patient Contact Examples Device Classification Minimum Inactivation Level Intact skin Non-Critical Cleaning and/or Low/Intermediate /High Level Disinfection Mucous membranes or non-intact skin Sterile areas of the body, including blood contact Semi-Critical Critical Cleaning and Sterilization or High Level Disinfection Cleaning and Sterilization Patient Contact Examples Device Classification Minimum Inactivation Level Intact skin Non-Critical Cleaning and/or Low/Intermediate Level Disinfection Mucous membranes or non-intact skin Semi-Critical Cleaning and Sterilization (or High Level Disinfection) Sterile areas of the body, including blood contact Critical Cleaning and Sterilization C. Diff CRE EBOLA 2

3 Ideal Sterilant: Wish List Effective Non toxic Fast Penetration Adaptable monitoring Cost effective Material compatibility Regulatory approval Goals of Sterilization Render medical devices safe for patient use Prevent infections Minimize potential for infection Prevent cross contamination Provide consistent sterile processing procedures Types of Items Reprocessed Utensils Plastics Instruments Rigid Instruments Complex Flexible Scopes 3

sterilizing agent Methods of Sterilization Traditional Sterilization Steam Gamma Irradiation Ethylene

4 Sterilization is not Magic Sterilization Process Process is complex Successful coordination of proper: Cleaning Inspection Assembly Preparation Packaging Loading Well maintained sterilizer Prepared/delivered sterilizing agent Methods of Sterilization Traditional Sterilization Steam Gamma Irradiation Ethylene Oxide Nontraditional Vaporized Hydrogen Peroxide Hydrogen Peroxide Gas Plasma Liquid chemical sterilization 4

Steam Sterilization Steam Sterilization Rapid heating Superior penetration Brief exposure times Non-toxic/no residues Easily produced Economical, dependable Materials compatibility Capable of

5 Steam Sterilization Steam Sterilization Rapid heating Superior penetration Brief exposure times Non-toxic/no residues Easily produced Economical, dependable Materials compatibility Capable of processing large volumes Heat sensitive devices Extended cycles Complex, specialized instrumentation Steam quality/purity Wet loads How Does Steam Sterilize? Saturated steam Direct contact Under pressure Specific temperature Specific time exposure Combination of heat energy and water Kills microorganisms by coagulation 5

Prevacuum Gravity Displacement SFPP Prevacuum

Intended for emergency use only Immediate

use Rigid container validated for immediate

Phase Air evacuated Steam enters Warm steam

6 Prevacuum Gravity Displacement SFPP Prevacuum 0 psig Immediate Use Steam Sterilization Intended for emergency use only Immediate patient use Process single items No routine use Rigid container validated for immediate use Phases of Steam Sterilization Conditioning Phase Air evacuated Steam enters Warm steam enters chamber from jacket Chamber/load heat-up to set temperature 6

Phases of Steam Sterilization Exposure Phase Begins when pre-selected temperature along with pressure are achieved Phases of Steam Sterilization Exhaust

7 Phases of Steam Sterilization Exposure Phase Begins when pre-selected temperature along with pressure are achieved Phases of Steam Sterilization Exhaust Phase Air displaces steam Steam removed Air injected Steam Critical Parameters Time/temperature relationship Pressure/temperature Steam quality (moisture) 7

Low Temperature Sterilization Low Temperature Processing AAMI/ANSI ST 58: Chemical sterilization and high-level

(2015) AAMI/ANSI ST 41: Ethylene oxide sterilization 4th edition (2010) erratum) AAMI TIR 34: Water for the reprocessing

ASGE/SGNA Multi-society guideline on reprocessing flexible gastrointestinal endoscopes (2011) Low Temperature

8 Low Temperature Sterilization Low Temperature Processing AAMI/ANSI ST 58: Chemical sterilization and high-level disinfection. 3rd edition (2013) ANSI/AAMI ST 91: Flexible and semi-rigid endoscope reprocessing in healthcare facilities. (2015) AAMI/ANSI ST 41: Ethylene oxide sterilization 4th edition (2010) erratum) AAMI TIR 34: Water for the reprocessing (2014) AORN Guidelines (2015) CDC Guideline for Decontamination and Sterilization in Healthcare Facilities (2008) ASGE/SGNA Multi-society guideline on reprocessing flexible gastrointestinal endoscopes (2011) Low Temperature Sterilization Options Humidified Ethylene Oxide (EO) Hydrogen Peroxide gas With Plasma Without Plasma Humidified Ozone gas Liquid chemical sterilization 8

9 Low Temperature Sterilization Ethylene Oxide Mode of Action: Alkylation Liquid Peracetic Acid Mode of Action: Oxidation Gas Plasma Mode of Action: Oxidation VHP (Vaporized Hydrogen Peroxide) Mode of Action: Oxidation Ethylene Oxide Sterilization EO Historical Overview Discovered in s Health care applications 1980 s Safety issues surface 1990 s Environmental concerns Today 100% EO dominates 9

10 Ethylene Oxide (EO) Pros Used as sterilant in U.S. since 1960 s Exceptional penetration ability makes process of choice for wide variety of items Excellent material compatibility Effective on wide variety of microorganisms Cons Long cycle time (10-24 hours including aeration) Known health hazard and carcinogen Extremely toxic EtO monitoring required Refer to AAMI ST 41 Ethylene Oxide (EO) Kills microorganisms by alkylation Combines with genetic material in the cell, destroys the cell s ability to metabolize and reproduce Used in industry and in hospitals Mixed blends used in large chamber sterilizers 100% systems are for chambers <10 cubic feet Critical Load Parameters Time, Temperature EO Concentration Relative Humidity 100% EO Cycle Phases Occur below atmospheric pressure, under vacuum Conditioning Humidification Charge Sterilize Exhaust Air Wash/ Aeration 31 10

100% EO Increased productivity and cost savings Eliminate need for external tanks Safety features minimize operator exposure Vacuum cycle Single-use cartridges In-chamber placement In-chamber

11 100% EO Increased productivity and cost savings Eliminate need for external tanks Safety features minimize operator exposure Vacuum cycle Single-use cartridges In-chamber placement In-chamber aeration EO Critical Parameters EO gas concentration mg/l for 100% Relative humidity Necessary for gas to penetrate cell wall Temperature High 130 F (54.4 C) Low 100 F (37.8 C) Exposure Varies between 1 6 hours EO Aeration Requirements Removes residual EO before use or storage Device manufacturer provides parameters Aeration in sterilizer: 100% EO = 12 hours at 130 F (37.8 C) 36 hours at 100 F (54.4 C) EO/Blend = 12 hours at 130 F 32 hours at 100 F NO AERATION IN SEPARATE CHAMBER 11

EO Must Be Used With Care Known human carcinogen Improper use hazard Acute exposure Irritation, CNS depression Chronic inhalation Cataracts, cognitive impairment, neurologic dysfunction Occupational

12 EO Must Be Used With Care Known human carcinogen Improper use hazard Acute exposure Irritation, CNS depression Chronic inhalation Cataracts, cognitive impairment, neurologic dysfunction Occupational exposure Hematologic changes, some cancers EPA EtO National Emission Standards March 2008 Sterilize full loads Demonstrate, submit compliance status with management practice standard Record keeping Compliance status Sterilizers not equipped with air pollution control devices March 2010 Single chamber process no separate aerator EO Monitoring Occupational Safety & Health Administration (OSHA) permissible exposure limit (PEL) 1 ppm/8 hour time weighted average (TWA) 5 ppm/15 minute TWA EO is imperceptible until well above OSHA PEL No odor until about 500 ppm Dangerous to life and health at about 800 ppm OSHA requires continuous area monitoring Personnel monitoring of the employee breathing zone is also recommended 12

EO Monitors Area Monitor Personnel Monitor Ethylene

Endoscopes Ensure devices are clean and dry ETO is

Low pressure (vacuum) systems Venting cap required

endoscope manufacturer Conditioning, sterilization and

Processing time typically >15 hours Endoscopes may

13 EO Monitors Area Monitor Personnel Monitor Ethylene Oxide and G.I. Endoscopes Ensure devices are clean and dry ETO is sensitive to the presence of residual soil and water Low pressure (vacuum) systems Venting cap required Sterilization parameters should be validated by endoscope manufacturer Conditioning, sterilization and aeration Post-sterilization aeration is essential Processing time typically >15 hours Endoscopes may have a limited number of cycles before requiring extensive repair New FDA Guidance on Reprocessing (March 17, 2015) 13

14 New FDA Guidance on Reprocessing (March 17, 2015) Oxidizing Chemistries What Are Oxidative Chemistries? Class of compounds that contain an additional atom of oxygen Use oxidation to interrupt cellular functions Kills microorganisms Excellent cleaning, disinfecting, and sterilizing agent Oxygen is a by-product 14

Today s Trends New, efficient ways to reprocess For safety, efficiency, efficacy Manual

commonly used low temperature option used in healthcare Pros/Cons not yet known

15 What Are Oxidative Chemistries? Example - Hydrogen peroxide Environmentally friendly Efficacy and surface compatibility Today s Trends New, efficient ways to reprocess For safety, efficiency, efficacy Manual Dialdehyde Automated processing Oxidizing agent shift Hydrogen and Ozone Sterilization Least commonly used low temperature option used in healthcare Pros/Cons not yet known Broad-spectrum antimicrobial Patent-pending delivery system Strong oxidizer By-products oxygen and water vapor through catalytic converter Sterizone Sterilization System 15

16 Peracetic Acid Sterilization Peracetic Acid Historical Overview Germicidal properties reported Food processing, beverage industry System 1 sterilizer used to sterilize surgical instruments, flexible endoscopes System 1E cleared by FDA Liquid Peracetic Acid Rapid cycle time Standardized Broad range of devices Point-of-use No environmental monitoring No sterile storage Immediate use Devices immersible Quick connects for devices with channels (flexible scopes) 16

organic soil PA Removes Organic Residues Biopsy channel after repeated processing in glutaraldehyde Same channel after 5 cycles utilizing oxidative

17 How Does Peracetic Acid Sterilize? Uses oxidation to interrupt cellular functions Kills microorganisms Mechanism of action non-specific Biocidal oxidizer maintains efficacy in presence of organic soil PA Removes Organic Residues Biopsy channel after repeated processing in glutaraldehyde Same channel after 5 cycles utilizing oxidative chemistries 14 Liquid chemical sterilization process Microprocessor controlled processor Automated 0.2% PAA in formulation 6 minute exposure at ~46 o C (115 o F) Extensively treated water rinsing 23 minute cycle Immediate use Monitor with chemical indicator and spore test 17

Peracetic Acid Sterilant Single-use container, S40 Two components: Active ingredient

efficacy requirements 39 Peracetic Acid Cycle Phases Conditioning Exposure 6 minutes

displacement Water filter integrity test End of cycle signal, access chamber 43 PAA

18 Peracetic Acid Sterilant Single-use container, S40 Two components: Active ingredient = 35% Peracetic Acid (PA) Buffers = proprietary chemical protection system Meets efficacy requirements 39 Peracetic Acid Cycle Phases Conditioning Exposure 6 minutes 2 sterile water rinses Rinse water preparation with UV Light 1 minute sterile air displacement Water filter integrity test End of cycle signal, access chamber 43 PAA Critical Parameters Temperature C Exposure time 6 minutes Concentration 175 or greater 18

19 Vaporized Hydrogen Peroxide Sterilization Hydrogen Peroxide Gas..with and without plasma All systems use 59% hydrogen peroxide for sterilization but the sterilizers function differently Antimicrobial activity is due to hydrogen peroxide gas not the plasma Plasma used as a heat source during conditioning and to break down peroxide residuals prior to reintroducing fresh hydrogen peroxide into the cycle Hydrogen peroxide gas (no plasma) uses a vacuum to remove residuals from the chamber Area monitoring for H 2 O 2 is not currently required but often recommended Hydrogen Peroxide Sterilization Hydrogen Peroxide sterilizers developed in the 1990s Kills organisms by the process of oxidation combines with and changes the structure of other molecules Used in concentrations of 35% - 90% (with water 65% - 10%) Cycle times range from minutes Refer to AAMI ST58 for best practice standards for Hydrogen Peroxide 19

Vaporized Hydrogen Peroxide Hydrogen peroxide gas is generated from liquefied hydrogen peroxide solutions (typically 50% - 60% range) The vaporized solution is introduced into the chamber under

20 Vaporized Hydrogen Peroxide Hydrogen peroxide gas is generated from liquefied hydrogen peroxide solutions (typically 50% - 60% range) The vaporized solution is introduced into the chamber under vacuum to allow rapid penetration Hydrogen peroxide degrades rapidly so it is then removed from the chamber, aerated and then repeated Vaporized Hydrogen Peroxide Pros Relatively short cycle time (28-55 minutes) Effective against wide range of organisms No personnel monitoring currently required Wide range of material compatibility Inexpensive cycles Not as moisture sensitive Sterile storage Larger chamber capacity No venting required Non-toxic by-products Cons Requires validated packaging materials Size restrictions for sterilization of lumens Device validation ongoing Refer to ANSI/AAMI ST 58 How Does VHP Sterilize? Oxidizing agent Liquid HP dropped on hot surface Creates dry vapor Effective antimicrobial at low concentration Injected under vacuum conditions Easily permeates the load 20

21 What is V-PRO Max? Low temperature sterilization Uses VHP (Vaporized Hydrogen Peroxide) Sterile storage 136 L chamber capacity 55 minute lumen cycle 28 minute non-lumen cycle 35 minute flexible scope cycle dual and single channel surgical scopes Phases of Vaporized HP Sterilization Condition Vacuum pulses to remove air, moisture 2 nd condition to remove any detected moisture Sterilize pulses sterilant into chamber Aeration Vacuum pull to evacuate vapor in chamber V-PRO max Cycles Lumen Non Lumen Flexible Instruments with diffusion-restricted Non lumened instruments including 1. Two flexible endoscopes with a light cord (if not spaces such as the hinged portion of non lumened rigid endoscopes integral to endoscope) and mat with no additional forceps and scissors non lumened instruments with load stainless steel diffusion-restricted The flexible endoscopes may contain either: Medical devices, including rigid areas such as the hinged portion of endoscopes, with a single stainless steel forceps or scissors a single lumen with an inside diameter of 1 mm or lumen with: larger and a length of 1050 mm or shorter OR single inside diameter of.77 mm or two lumens with l mm or larger and length of 998 larger and a length of 500 mm or shorter mm or shorter a dual channel lumen of second lumen with l mm lumen or larger and.77 mm inside diameter and length of length of 998 mm or shorter OR 527 mm or shorter lumen with l mm inside diameter or larger and a triple lumen inside diameter of length of 850 mm or 1.2 mm and 310 mm length OR OR: one flexible scope and non lumened 2.8 mm diameter and 317 mm length instruments pounds Maximum 20 lumens Stainless steel pounds No lumens or flexible scopes 24.0 pounds (mixed load) No stainless steel lumens 55 minutes Sterilize 32 minutes 4 pulses.4 to Torr Temperature C 28 minutes Sterilize 12 minutes 4 pulses.4 to Torr Temp C 35 minutes Sterilize 20 minutes 4 pulses.4 to Torr Temperature C 21

Vaporized HP Parameters Temperature 48.5 51.5 Time 32 minutes Pressure.44 to 6.

22 Vaporized HP Parameters Temperature Time 32 minutes Pressure.44 to to 500 Torr Sterilant expiration date Hydrogen Peroxide Plasma Sterilization Hydrogen Peroxide Gas Plasma States of matter Solid, liquid, gas Plasma is a gas that has been further energized and is considered the 4 th state of matter Plasma is formed on any remaining liquid/gas in the chamber Antimicrobial activity due to hydrogen peroxide, plasma used as a heat source during conditioning and to break down peroxide residuals prior to reintroducing fresh hydrogen peroxide When energy is turned off, bi-products are formed (water & oxygen) 22

Hydrogen Peroxide Gas Plasma Rapid cycle times Wide materials compatibility Easy to use cassette Easy installation Sterile storage No venting required No personnel monitoring No toxic

Low temperature: 37 44 C (104 122 F) H 2 O 2 + water + vacuum + energy = gas plasma Hydrogen peroxide solution injected from cassette Vapor generated from 59% liquid peroxide Vapor diffuses

23 Hydrogen Peroxide Gas Plasma Rapid cycle times Wide materials compatibility Easy to use cassette Easy installation Sterile storage No venting required No personnel monitoring No toxic by-products Various chamber sizes Moisture sensitivity Items must be dry Limited penetration (lumens) Loading considerations Limited wrapping products How Does HP Gas Plasma Sterilize? Low temperature: C ( F) H 2 O 2 + water + vacuum + energy = gas plasma Hydrogen peroxide solution injected from cassette Vapor generated from 59% liquid peroxide Vapor diffuses exposing all surfaces in load Electrical field created by radio frequency creates gas plasma HP Gas Plasma Cycle Phases Vacuum Injection Diffusion Plasma Vent Cycle times: Vary Microprocessor monitors ALL parameters 48 23

24 HP Gas Plasma Critical Parameters Time Temperature Hydrogen peroxide concentration Vacuum level Quality Assurance Monitoring Quality Assurance Monitoring Needed for all sterilization methods Quality assurance is ongoing References: AAMI ST79:2013 (Steam) AAMI ST41:2008 (EO) AAMI ST58:2013 (Chemical Sterilization) AAMI ST91:2015 (Flexible and Semi-Rigid Endoscopes 24

Quality Assurance Monitoring Physical monitors Chemical monitors Biological

Monitors Biological Indicators Chemical Indicators Leak Test Physical

Evaluate while cycle is in progress Verify time, temperature, pressure

25 Quality Assurance Monitoring Physical monitors Chemical monitors Biological monitors Environmental (EO only) Record keeping Routine Monitoring Physical Monitors Biological Indicators Chemical Indicators Leak Test Physical Monitors Permit earliest possible detection of equipment malfunction Evaluate while cycle is in progress Verify time, temperature, pressure readings Provides permanent record All operators must know how to read, interpret results 50 25

Chemical Indicators for Steam Sterilization Class 4 Multi-parameter indicators react to two or more critical parameters of sterilization Class 5 Integrating indicators

Challenge Packs Reacts to all critical parameters Performance correlated to the sterilization cycle Monitors more of the sterilization cycle than a BI Chemical Monitoring

26 Chemical Indicators for Steam Sterilization Class 4 Multi-parameter indicators react to two or more critical parameters of sterilization Class 5 Integrating indicators react to all critical parameters, is correlated to the performance of biological indicators Chemical Indicators for Steam Sterilization Class 6 Emulating Indicators and Challenge Packs Reacts to all critical parameters Performance correlated to the sterilization cycle Monitors more of the sterilization cycle than a BI Chemical Monitoring Monitor one or more process parameter Do not prove sterilization was achieved Detect failures in packaging, loading or sterilizer function CI specific to sterilization method 51 26

Biological Indicator Validates the sterilizer/cycle Spore selected = the most resistant to kill: Geobacillus stearothermophilus (Steam, PA, H 2 O 2

subtilis) for EO Follow instructions from manufacturer BI specific to sterilization process Include a Control sample 54 Quality Control Testing

applicable). Routine testing e.g., leak testing.

27 Biological Indicator Validates the sterilizer/cycle Spore selected = the most resistant to kill: Geobacillus stearothermophilus (Steam, PA, H 2 O 2 plasma, VHP) Bacillus atrophaeus (formerly B. subtilis) for EO Follow instructions from manufacturer BI specific to sterilization process Include a Control sample 54 Quality Control Testing Monitoring every device or load Physical monitors (temperature, pressure, exposure time, etc) and indicators (chemical and biological indicators, as applicable). Routine testing e.g., leak testing. Quality testing after installation or major repair Manufacturer recommended Typically 3 Process Challenge Devices (PCDs) with BI/CI Periodic product/load quality assurance testing Represents typical cycles/loads conducted at a facility Environmental Monitoring Required with EO only OSHA guidelines EPA regulations Area monitoring Personnel monitoring 57 27

Documentation and Record Keeping Epidemiological tracking Ongoing assessment Accurate documentation Complete records Maintain as required State or local statutes Facility policies 58

28 Documentation and Record Keeping Epidemiological tracking Ongoing assessment Accurate documentation Complete records Maintain as required State or local statutes Facility policies 58 Documentation/Monitoring Biological Indicator Monitoring Log Sterilizer # Cycle # B.I. Lot # Control Lot # B.I. Test in Incubator B.I. Test Out of Incubator 24 Hr. Test Result B.I. Control in Incubator B.I. Control Out of Incubator (24 Hr. max.) Comments Date Time Date Time Date Time Date Time Initials Initials Initials Initials Sterilizer # Cycle # B.I. Lot # Control Lot # B.I. Test in Incubator 24 Hr. B.I. Test Result B.I. Control in Incubator B.I. Control Removed From Incubator Comments Date Time Date Time Date Time Date Time Initials Initials Initials Initials Sterilizer # Cycle # B.I. Lot # Control Lot # B.I. Test in Incubator 24 Hr. Test Result B.I Control in Incubator B.I. Control Removed From Incubator Comments Date Time Date Time Date Time Date Time Initials Initials Initials Initials Sterilizer # Cycle # B.I. Lot # Control Lot # B.I. Test in Incubator 24 Hr. Test Result B.I. Control in Incubator B.I. Control Removed From Incubator Comments Date Time Date Time Date Time Date Time Initials Initials Initials Initials Sterilizer # Cycle # B.I. Lot # Control Lot # B.I. Test in Incubator 24 Hr. Test Result B.I. Control in Incubator B.I. Control Removed From Incubator Comments Date Time Date Time Date Time Date Time Initials Initials Initials Initials Load Record Documentation Sterilization Load Record DATE: DEPT ITEM DESCRIPTION POUCH TRAY/PEEL QTY STERILIZER #: 2 LOAD #: 3 TIME CYCLE STARTED: 4 OPERATOR INITIALS: 5 CYCLE SELECTED: Lumen Non Lumen Flexible 6 7 STERILIZATION PARAMETERS MET: Y N 8 9 LOAD REMOVED BY: BI TEST INCLUDED: Y N CHEMICAL INDICATOR READ BY: 15 CHEMICAL INDICATOR RESULTS: PASS FAIL

Staff Education Tools Instructions for Use Draft work instructions Competency check-list In service/training Maintenance manual Competency development Identification of department

29 Staff Education Tools Instructions for Use Draft work instructions Competency check-list In service/training Maintenance manual Competency development Identification of department Super-users Return demonstration of competency from Super-user Transfer of responsibility to end-user department for internal competency completion Thank you!! Questions?? Always Take time to Smile 29

30 References Chemical Indicators Guidance for Selection and Use, and Interpretation of Results; Association for the Advancement of Medical Instrumentation (AAMI), (Arlington, VA: AAMI, 1999) Ethylene oxide sterilization in healthcare facilities, ANSI/AAMI: ST 41 (Arlington, VA: AAMI, 2008) Steam sterilization and sterility assurance in healthcare facilities, ANSI/AAMI: ST 79 (Arlington, VA:AAMI, 2013) Chemical sterilization and high-level disinfection in health care facilities ANSI/AAMI ST58:2013 Flexible and semi-rigid endoscope processing in health care facilities, ANSI/AAMI ST91:2015 Chemical Sterilization; Association for the Advancement of Medical Instrumentation (AAMI), Arlington, VA: AAMI References Carter, P and Wright, M. The Lowdown on Low Temperature Sterilization for Packaged Devices. Healthcare Purchasing News, July 2008 Principles & Methods of Sterilization in Health Sciences, 2nd Edition, J.J. Perkins, (Springfield, IL: Charles C. Thomas Publisher, September 2008) Recommended Practices for Sterilization in the Practice Setting; Association of Perioperative Registered Nurses (AORN) Standards and Recommended Practices, (Denver, CO: AORN, 2014) Sterilization of Health Care Products General Requirements for Characterization of a Sterilizing Agent and, the development, validation and, routine control of a process for medical devices, ANSI/AAMI/ISO Sterilization Technology for the Health Care Facility, 2nd Edition, M. Reichert and J. Young, (Gaithersburg, MD: An Aspen Publication, 1997) 30

Responses 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