Biological indicator testing procedure Rapid-read biological indicators provide results in 20–25 Sep 15, 2023 · Testing Procedure of Biological Indicators: During the testing procedure, a carrier material with bacterial spores resistant to sterilization is used as a biological indicator to ensure safety. This test serves as one of the simpler tools that an end user can use to ensure the quality of the product they are receiving. Assistant (Microbiologist)/Executive 3. All monitoring records, including printouts of operational parameters, chemical indicator results, and spore testing since the last negative BI test should be examined. Routine biological monitoring shall be done 1. Study with Quizlet and memorize flashcards containing terms like All loads containing implantable devices should be, Biological monitoring of the hydrogen peroxide-ozone sterilization process should be performed, For testing of rigid sterilization containers, the biological indicator should be placed and more. Incubation How To Spore Test Your Autoclave There are three ways to spore test your autoclave. PRINCIPLE OF TESTS: Achieve peace of mind in your biological indicator testing requirements with our expert guidance. 1 Doing : Tech. 0 This test is typically performed during validation as well as during routine production as a lot release test. It does not indicate acceptable sterilization. Identify the Bionova® BT20 Indicator by writing the sterilizer number (in case of having more Sep 11, 2022 · Biological Indicator Testing Procedure The carrier material is enclosed within a glassine envelope or a vial. A sterilization process should be verified before it is put into use in healthcare settings. The test methods and carriers used with the BIER may be adapted to the specifics of the biological indicator. Test system containing viable microorganisms inoculated onto a carrier and contained within a primary pack, ready for use and providing defined resistance to a specified sterilization process under defined reference conditions. 7 Cool rapidly in ice water. IAHSCMM, Chicago, IL, USA. While there are Process Challenges Devices available for prevacuum cycles, gravity cycles, and prevacuum IUSS cycles, there are no pre-assembled Simply, parametric release allows product to be released to the market based only on process records instead of the traditional biological indicator sterility test. 7770 A self-contained biological indicator is designed so that the primary package, intended for incubation following sterilization processing, contains the growth medium for recovery of the process-exposed microorganisms. . 0 RESPONSIBILITY 3. Biological indicator testing is essential to prove your sterilization process effectiveness, but the evaluation procedure is often challenging with certain products due to design or sterilization requirements. 5. 4) Record the results. BI use viable spores resistant to sterilization – either self-contained or indicator strips. There are two types of microbiological indicators: biological and enzymatic. Running Apr 17, 2024 · To describe the procedure for the enumeration of spore count in Biological Indicators. Biological indicators are also Apr 17, 2024 · To validate autoclave with a biological indicator for sterilization efficiency. Inside the thermoplastic culture tube is a sealed-glass ampoule of specially-formulated soybean casein digest culture medium containing a pH color indicator which turns a dramatic yellow when spores grow. May 15, 2024 · A spore test should be used at least weekly to monitor sterilizers, and should use a matching control (i. Mar 28, 2023 · Review the specific procedure(s) for the sterilization process selected and the methods for controlling and monitoring the process. Single Measurement and more. Testing procedure for table-top sterilizers (continued):1 2 The BI test pack procedure should include the following steps: a. Testing procedure: o Secure a biological indicator test containing endospores such as BT Sure (available from The Safety Office at no cost, or from both Fisher Scientific and VWR) o Tie a piece of string to the testing vial containing spores to facilitate retrieval of the vial after the autoclave run. 11. How to use chemical indicators, biological indicators, and process challenge devices to monitor sterilization; Potential causes of a positive biological indicator; Steps to investigate a positive biological indicator; IPAC Self-Audit Checklist; The RCDSO is only one component of a larger system in Ontario to protect the health and well-being of Feb 24, 2022 · indicators as the yellow color is noticed and dispose of as mentioned below in the "Interpretation of Test Results" section. 0 SCOPE This is applicable to validate autoclave with the biological indicator for sterilization efficiency. 221. Asst. Visual Inspection » Defects that indicate sterility or stability problems must be investigated to determine the cause according to the facility’s SOPs. We have done the BI test this way for years and no one has ever said it was wrong. Readout: 24 hours. Mar 31, 2003 · Step Two — Review sterilization procedures. Dick test procedure: The test pack is placed in a specific location within the sterilizer chamber of vacuum steam sterilizers . 2–5 The appropriate standard should be followed for the biological indicator. Unlike chemical or physical indicators that only indicate certain conditions were met, BIs confirm the actual destruction of challenging microbial life. EHS Validation Procedure. The BIs are placed during validation to assess the challenge of the product bioburden to the sterilant and establish a comparison of the resistance of The purpose of this Standard Operating Procedure is to define the selection and usage of Biological Indicator Spore Strips and ampoules when validating thermal processes or equipment. 0 RESPONSIBILITY Microbiologist - Quality Control 4. If it remains purple, the test is a pass. 1 B. Instructions for use 1. The most common test Mar 25, 2015 · Biological spore testing is performed monthly on all research autoclaves used for biological waste, and results will be recorded on a monthly autoclave log form. 0 ACCOUNTABILITY Manager - Quality Control. 0 x 10 6 spores/unit population of viable spores of Geobacillus stearothermophilus ATCC 7953. If the indicator has changed from pink to brown then the temperature within the sterilizer was sufficient. Obtain biological indicator ampules, free of charge, from Environmental Health and Safety by emailing The regulations USP (United States Pharmacopoeia), EP (European Pharmacopoeia) and DAB (Deutsches Arzneibuch), recommend the use of bioindicators during the Nov 8, 2018 · Using biological indicators in the autoclave steam sterilization process helps validate that the conditions to kill microorganisms were met. Remove BTSure biological indicators from the beakers. This form of biological indicator together with the self-contained growth medium can be considered a system. Log records should be kept for a minimum of three years. Biological Indicator (BI) testing, Chemical Indicator (CI It must be remembered to include a positive control in with the group of process indicator BI. 2007. • Appendix A: Chemical Indicators: A Problem-Solving Flowchart • Appendix B: Biological Indicators: A Problem-Solving Flowchart • Appendix C: Bowie-Dick Test: A Problem-Solving Flowchart • Non-Alberta Health Services Documents: o. Section 13. This is advantageous in that it eliminates the routine costs and risks associated with biological indicators and laboratory testing. Interpretation: Carefully analyze spore test results for any signs of a failed test, which might indicate sterilizer malfunction. The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Geobacillus stearothermophilus (formerly Bacillus stearothermophilus). Sterilization monitoring is necessary for each autoclave load, including mechanical and chemical indicators as required and recommended, plus, depending on your location, spore testing (biological indicators). 1 states, “Health care personnel should select BIs that consist of spores of . There is a wide variety of sterilization processes in common use, and biological indicator manufacturers are not able to foresee all possible uses of their product. ISO 11737-2 describes the methodology, but its scope is strictly limited to medical device testing and sterilization validation using a reduced or partial sterilization exposure. 0 SCOPE This procedure is applicable for Biological Indicators as per listed below. in Section 13. EHS will coordinate biological validation testing with laboratory staff. A color change from rose to brown/blackconfirms that the biological indicator has been exposed to the steam sterilizationprocess. vendor. Insert thermometer into the control McCartney bottle. As soon as possible, repeat biological indicator test in three consecutive sterilizer cycles. 2 Checking: Executive/Manager 4. A control BI tests the viability of the biological spores and the effectiveness of the biological indicator. Geobacillus stearothermophilus RELEASE INSPECTIONS AND TESTING (2) All release testing procedures (e. Spore testing provides a reliable method for sterility assurance. 2. 0 Accountability Head of the Department 5. Nelson Labs offers BI testing 6 days a week. ” Are these the same? MTF: Yes, BIs and spore tests refer to the same monitoring procedure. All steam, ETO, and other low-temperature sterilizers are tested with biological and chemical indicators upon installation, when the sterilizer is relocated, redesigned, after major repair and after a sterilization failure has occurred to ensure they are functioning Feb 25, 2024 · The Biological Indicators to be challenged must have minimum 1. We run the test pack by itself. Biological Indicators (BIs) Biological indicators contain a known number of live microorganisms and are used to assess the adequacy of a sterilization cycle. The BI is exposed to the sterilization process and then incubated to determine whether any endospores survive. This procedure applies to Process Analytics personnel who will perform incubation procedures. Examine the positive indicator at 18 and 24 hours. Ethylene Oxide (ETO) Cycle Validation – Microbiological Requirements Validation Protocol Bioburden biological indicator manufacturer is critical for obtaining correct results. Follow the manufacturer’s directions for how to place the biological indicator in the sterilizer. A positive result, indicating the presence of viable spores Oct 18, 2016 · Q: We have always run the biological test (BI) in the morning immediately after the Bowie-Dick test to make sure we do not forget to perform the test. In general, a biological indicator is composed of a population of The overkill method (AAMI/ISO 11135 Method C) is most commonly used when performing an EtO sterilization validation. /Executive 3. II. Oct 4, 2007 · A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy Sep 28, 2018 · Incubation: Follow the manufacturer's instructions for the biological indicator testing procedure, including incubation time, temperature, and conditions. Questions arise as to which criteria to use to accept a lot of BIs if one performs a D -value assessment and what variation allowance is acceptable. Manufacturers, therefore, label biological indicators according to their intended use. Once the biological indicators have been autoclaved they must be disposed in a biological waste bin. Start timing when the temperature inside the control bottle reaches the required temperature. If it turns yellow, the test has failed. 3) The recommended incubation time is 24 hours. Apr 17, 2024 · To clearly define the procedure for procurement, storage and handling of Biological Indicator. stearothermophilus 3. If the autoclaved indicator exhibits growth, the validation has failed and will be repeated. The sterilizer's operations manual as well as the practice's written instrument sterilization policies should be reviewed. All three types of biological indicators (spore strips, EZ Test ampoules and glass ampoules) must be autoclaved for no less than 30 minutes for 121 o C. , thermocouples, pilot bottles, and biological indicators) should be described, including the number and location of each as well as acceptance and rejection specifications. Title Enumeration of Biological Indicators Place McCartney bottle containing 10 mls of distilled water alongside the test sample. Carefully retrieve the indicator from the test package. Recommended sub culturing procedure techniques are available upon request. Provided that the biological indicator manufacturer produces the based upon detailed standard specifications, i. The incubator heats the activated BIs to temperatures that promote the metabolism and subsequent detection of viable test organisms under evaluation. B/T Sure biological indicators can be sub cultured if identification of positive growth is desired. biological indicators throughout the test load. 1 Feb 1, 2021 · Gravity IUSS cycles should be monitored by using biological indicators and a Type 5 or Type 6 chemical indicator (CI) strip placed within a containment device and ran in an otherwise empty chamber. Biological Indicators must meet the In-house standards, so determine the Inhouse spore population of Biological indicator strips/ampoules. Take a sufficient number of groups of specimens of biological indicators in their original individual For Biological Indicator for Dry-Heat Sterilization, Paper Carrier, use an apparatus of known thermodynamic characteristics that has been validated for compliance with the requirements for safety 1 and performance, 2 that consists of a sterilizing chamber equipped with a means of heating the contained air, preferably electrically rather than gas fired, and that has adequate movement of the air Biological indicators for specific sterilization processes not covered by reference test conditions in relevant parts of ISO 11138 should comply with the general requirements in this document, including the resistance testing procedures. Apr 17, 2024 · To describe the procedure to validate autoclave with the biological indicator for sterilization efficiency. In-office spore testing products from HuFriedyGroup include the ConFirm™ 10 Steam Biological Indicators, self-contained in-office monitoring tests that deliver results in 10 hours. 6. It is important to note that biological indicators are not intended to indicate that the products in the load being sterilized are sterile. Incubators play a crucial role in the sterility assurance process by testing if all viable organisms in the biological indicator test vial have been eliminated. A biological indicator contained within a PCD shall be used to test the sterilizer for each type of cycle used (e. These validation tests are used Remove the beakers from the autoclave; allow indicators to cool for at least 10 minutes. Once the BI test pack is assembled, label it with the sterilizer number, the date, load number and “TEST” (to identify it post sterilization) before being exposed to the sterilization cycle. They are indicators that determine the lethality of sterile processing indicating, that is, they indicate whether a material subjected to a sterilization process is completely free of living microorganisms. It is recommended to run your test cycles at half of the desired steriliza-tion time (this is referred to as the “half-cycle” method). Such biological indicators might not be well enough described, When performing Biological Indicator Population Verification testing, BIs are macerated using a validated technique such as blending or by sterile glass beads. , biological indicator and control from same lot number). Get results in only 20 minutes, and is 100% accurate and FDA-approved. BIs and spore tests remain the best assurance that sterilization equipment is functioning, and instrument processing procedures are being performed correctly. The items from the suspect load(s) should be recalled and Study with Quizlet and memorize flashcards containing terms like Indictor, Biological Indicator, Over time vs. Geobacillus stearothermophilus (ATCC® 7953) 10^5 or 10^6 spores per vial. com | Phone 1-440-354-2600 | lifesciences@steris. g. ) Interpretation of Test Results Biological Indicator: 1. The BI is exposed to the sterilization process and then incubated under defined growth conditions to determine whether any spores survived the process. Biological indicators for specific sterilization processes not covered by reference test conditions in relevant parts of ISO 11138 should comply with the general requirements in this document, including the resistance testing procedures. The BIs are placed during validation to assess the challenge of the product bioburden to the sterilant and establish relationships between such and the BIs. Daily preparation of biological incubator begins by incubating an unprocessed control BI. 3. One type is natural product sterility testing and the other is biological indicator sterility testing. Biological indicators (BI), also known as a spore test, enable validation of sterilizer cycles by assessing the sterilization process directly. • All experimental BI(s) must show no growth for Geobacillus Stearothermophilus. 0 Scope This procedure is applicable for Autoclave installed in microbiology area of quality control laboratory. These are tested in accordance with USP <55> Biological Indicators – Resistance Performance Tests or manufacturer’s instructions. . Oct 21, 2019 · Just like a smoke detector alarming, a failed biological indicator tells sterile processing staff that action needs to be taken immediately. The BI is enclosed in a glassine envelope or vial and exposed to the sterilization process. 2 Checking : Executive/ Manager 4. Selected Autoclave and Cycle run must be used for the disposal of all biological indicators. If the spores are killed during the cycle, it is presumed that microorganisms on instruments are also killed. Mar 25, 2015 · Biological spore testing is performed monthly on all research autoclaves used for biological waste, and results will be recorded on a monthly autoclave log form. Commercially available BIs are non-pathogenic (harmless) and are specific for the type of sterilization process being monitored. 1 The Director, Process Analytics (PA) has the authority to define this Apr 2, 2006 · USP General Chapter (1035) "Biological Indicators for Sterilization" does not mention under the area of user's responsibility, the testing–result–acceptance criteria. 2 and on Bowie-Dick testing in Section 13. Monitoring vacuum-assisted and gravity air-displacement Steam Sterilization processes at 121-135 °C. Such biological indicators might not be well enough described, or might be used for novel sterilization Oct 21, 2024 · What Is a Biological Indicator & How Does It Work? A biological indicator is a test system that’s embedded within a process challenge device (PCD) and used to verify the efficacy of certain sterilization processes — such as those that rely on sterilizing agents like steam and vaporized hydrogen peroxide. Positive spore test results are a relatively rare event 838 and can be attributed to operator error, inadequate steam delivery, 839 or equipment malfunction. If additional spore tests remain positive, the items should be considered nonsterile, and supplies processed since the last acceptable (negative) biological indicator should be recalled. 3. 1 . A spore test should also be used for every load with an implantable device What is a Biological Indicator? Biological indicators are used to validate sterilization processes in different industries. • All specified parameters must be met. 0 Responsibility 3. 0 SCOPE This SOP is applicable for the enumeration of spore count in Biological Indicators. Make sure you are purchasing biological spore indicators and not just heat test strips. e. OPTIONS: o In Office: If perform your testing in office, you will purchase the ampules from a vendor AND have to process the test ampule, incubate, read and record the FOR BIOLOGICAL INDICATOR TEST Maintain this checklist in your lab for six years. Procurement : Dec 20, 2023 · Objects, other than implantable objects, do not need to be recalled because of a single positive spore test unless the sterilizer or the sterilization procedure is defective. Test Acceptance Criteria: • For testing biological indicators (BI) must contain ≥610Geobacillus Stearothermophilus (ATCC 7953) spores. In ethylene oxide and dry heat sterilization, the test organism used is typically the endospore-forming bacteria, Bacillus atrophaeus, (ISO11138-2 Sterilization of health care products – Biological indicators – Part 2: Biological indicators for ethylene oxide sterilization processes and ISO11138-4 Biological indicators – Part 4 Biological Indicators (BIs) are considered the highest level of sterility assurance because they actually test the sterilizer's ability to kill specific strains of highly resistant organisms. Natural product sterility testing is performed after each half cycle to assure the product is rendered sterile by the process as required in USP23. 2. Examine the biological indicator for signs of color change during incubation BT20 / Self-contained Biological Indicator for Steam sterilization processes. F-IT-E 09/2018 EZTest steam and EO utilize a filter paper carrier, H 2 O 2 utilizes a stainless-steel disc carrier. Biological indicators are designed to measure the killing power of the sterilising process and are considered to be the most accurate method. 0 Scope . For the test, the biological indicators are placed in the plant or isolator and the well-known decontamination procedure is performed as standard. Jun 28, 2019 · Steam Sterilization video - BI Placement and Interpretation Nov 19, 2019 · ICC: I have heard of “biological indicators” and “spore tests. com LSFC-BR4165. Mar 28, 2024 · PROCEDURE FOR RECEIPT, ENUMERATION, USAGE AND DISPOSAL OF BIOLOGICAL INDICATORS: A biological indicator is a specific type of microorganism that is used to determine the effectiveness of a sterilization process. They consist of a predetermined number of microorganism spores. 8. Use of Controls: Biological indicators are supplied with each case (25) of test packs for use as positive controls. What is the biological indicator testing process? The biological indicator testing process beings with a product, with indicators attached, and is subjected to the gaseous sterilization method. Mar 22, 2013 · As soon as possible, repeat biological indicator test in three consecutive sterilizer cycles. Biological indicators are utilized to test the effectiveness of a given The test equipment for the determination of microbial resistance is described in substantial detail in ISO 18472, Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment. Sep 16, 2022 · The biological indicator testing process is as follows: The product, with indicators attached, is subjected to the Customer’s preferred sterilization method. Checkthe chemical indicator on the label of the biological indicator. Central Service Technical Manual, 7th ed. LABELING (1) (e. com Biological indicators (BI) are used to monitor the success of the sterilization process. 0 ACCOUNTABILITY Head of the Aug 6, 2024 · Sterility testing can be conducted for various reasons (on medical devices or biological indicators for sterilization validation, batch release testing, monitoring, etc. What are Biological Indicators (BIs)? Biological indicators are test systems containing viable microorganisms that offer a definitive method to verify the sterilization process. The HSK procedure requires a minimum of five different exposure times which must result in one set of samples demonstrating all growth, two sets of samples demonstrating fractional growth, and two sets of Biological indicator testing is essential to prove your sterilization process effectiveness, but the evaluation procedure can be challenging with certain products due to design or sterilization requirements. , visual inspections and testing) must be included in the facility’s documentation (see 17. Nov 28, 2023 · Sterilization Cycle Verification. ). Then that macerate is heat shocked and the suspension is diluted to yield colonies in the range of 30–300 colony-forming units (CFU) and then plated. 0 Authority and Responsibility . BI: Biological indicator. Determination of survival curves (see Biological Indicators 1035), or what has been called the fractional cycle approach, may be employed to determine the D value of the biological indicator preferred for the specific sterilization procedure. Dec 17, 2021 · To lay down the procedure for receiving, issuance and determination of spore population of biological indicator which are commercially available and are used in validation process of steam sterilizer. subtilis 2. 0 PROCEDURE The selection of an appropriate biological indicator for the particular process used is critical. These indicators are typically highly resistant to sterilization methods, such as endospores from Bacillus pumilus. Core Components As of 7/28/21, the VERIFY V24 Self Container Biological Indicator has been validated for use in the 100S Sterilizer, STERRAD™ 200 Sterilizer, STERRAD™ NX Sterilizer (with and without ALLClear™ Technology) and STERRAD™ 100NX Sterilizer (with and without ALLClear Technology). BI testing and sample requirements are outlined in numerous standards including USP <55>, the ANSI/AMMI/ISO 11138 series parts 1-4, ANSI/AAMI/ISO 14161, and ANSI/AAMI/ISO 11135. Achieve peace of mind in your biological indicator testing requirements with our expert guidance. The overkill method is based on demonstrating that the sterilization of a microbial challenge (biological indicator) exceeds the challenge posed by the bioburden of the product. What is the 1. 0 PROCEDURE These test cycles should be loaded in a way that is representative of the actual load to be sterilized. 5. 1 Routine biological monitoring with the use of a Process Challenging Device (PCD) shall be done daily in the first load of the day. You can search “biological indicator” on the internet and find results. (Note: If the positive control does not grow, do not use the units from this box. Examine the chemical label located on the Attest Biological Indicator label. As an end user prepares to perform this test they might ask the question ‘‘what procedure should I use?”. Obtain biological indicator ampules, free of charge, from Environmental Health and Safety by emailing (Bowie-Dick test) shall be performed every day the sterilizer is used. test and all applicable quality assurance guidelines are met Mentor, OH | sterislifesciences. Oct 21, 2024 · In this article — the eighth installment of our steam sterilization cycle series — we discuss two autoclave test cycles that medical and/or laboratory personnel can use to ensure their autoclave is performing properly: the Bowie-Dick test (also known as the dynamic air removal test) and the vacuum leak test. Observe colour change (blue to black) of the chemical indicator on the BTSure label. 1 Doing: Tech. For questions, contact an EH&S Biosafety Officer at ehsbio@uw. removing biological indicators from the sterilizer. &1S (USP31) Procedure Carry out the tests for D value at each of the applicable sets of sterilization conditions for which the packaged biological indicator under test is labeled for use. Unlike mechanical or chemical indicators, spore testing determines biological indicator, design differences are acceptable. Mail it out weekly/monthly to a spore test lab and get results (usually takes 1-2 weeks) Do it yourself in your own office, using a small spore test ampoule (aka biological indicator). 0 ACCOUNTABILITY Manager - Quality Control 5. Classes of Chemical Indicators 1 Class I Process indicator Usually applied to the outside of packages Respond to one or more critical process variables Class II Indicator for specific Tests Indicator for use in specific test procedures Bowie-Dick test Class III Sep 15, 2011 · This SOP describes the incubation procedures of Biological Indicators (BI) to determine the efficacy of sterilization cycles. Apr 17, 2024 · This SOP is applicable for the testing of Biological Indicators (BI) on the receipt (spore population verification and organism characterization) and testing Biological Indicator exposed to sterilization validations See full list on steris. o In order to reliably answer the question about the quality of a decontamination based on H 2 O 2, the batch of the biological indicator must be homogeneous with respect to existing resistances. edu or 206. SOPs). The indicators will be incubated by EHS for 24 hours at 60°C with a control that has been maintained at room temperature. If the biological indicator test result is negative you can resume use of the sterilizer. Jun 12, 2013 · There are two procedures used in this method: the Holcomb-Spearman-Karber (HSK) procedure and the Stumbo-Murphy-Cochran (SMC) procedure. When a failed BI occurs, you must follow your failed spore test protocol and quickly investigate possible operator errors or equipment failures using the checklists below. Apr 17, 2024 · Standard operating procedure to quality the biological indicators containing Geobacillus stearothermophilus (Bacillus stearothermophilus) ATCC 7953 and Bacillus atrophaeus (Bacillus subtilis) ATCC 9372 spores. We recently had a survey and were cited because we did not run the biological test in the first working load. 2 B. Then test the sterilizer with biological monitoring. Interpreting results is as simple as observing the test vial after incubation. The yellow color is evidence of bacterial growth and verifies viable biological indicator use. Two types of biological testing are utilized for qualifications. F-IT-E 09/2018 Total viable spore count testing is a common, in-coming inspection test for biological indicator (BI) users. NOTE: Colour change indicates exposure to steam. Sterility testing is conirmed with the use of biological indicators (BIs). 7. The fractional cycle approach, may also be used to evaluate the resistance of the microbial burden. 1 The details of individual Biological Indicator Evaluation Resistometers (BIERs) vary with the specifics of their design and the particular sterilization process in conjunction with which This vacuum test pack contains a temperature-sensitive chemical indicator (indicator sheet) that changes color when exposed to specific conditions, allowing for visual verification of the sterilization process. Jun 27, 2016 · Chemical indicator failure – in this case you should review the steps of the procedure and make sure everything seems to be functioning mechanically. , the ISO 11138 series, and the user uses the biological indicator as intended by the biological indicator manufacturer, testing of the resistance characteristics by the user is considered unnecessary. Then allow the biological indicator to cool outside the test pack for an additional10 minutes prior to crushing. • Chemical indicators must demonstrate test material (product) exposure. Test procedures for the use of BIER vessels for the evaluation of microbial resistance are defined in a series of ISO standards under the 11138 series. Activate and incubate an unexposed control indicator with every sixth test pack run. leecxk wstq hunv tkc emani fzsdclo vvr pphlgh dkmatk zhubf ilnswr chn vcv nmmrs uis