Steam sterilisation is a method of sterilisation in which moist heat in the form of saturated steam under pressure is used for sterilising surgical instruments. Moist heat helps destroy microorganisms, this is achieved through irreversible coagulation and denaturation of enzymes and structural proteins. It is the most widely used method of sterilisation and valued for being non-toxic and inexpensive. Steam sterilisation exposes each item to direct steam contact at the required temperature and pressure for a specified time. The ideal steam for sterilisation is dry saturated steam and entrained water (dryness fraction ≥97%) as per CDC guidelines.
Our certified Technical Service group is ready to demonstrate products and answer your questions related to sterilisation and reprocessing products, standards, and process troubleshooting.
Load monitoring is the process by which a load is monitored and released based on the final negative result of a Biological Indicator (BI) in a Process Challenge Device (PCD). According to ANSI/AAMI ST79, a BI should be used weekly, preferably daily, in each steam steriliser and in every load that contains an implant. Only a BI can detect the actual killing of microbial monitoring non-implant loads. As a best practice and to provide optimal patient safety, 3M recommends that every sterilisation load be monitored with an appropriate biological indicator.
When time is of the essence speed matters, choose Biological indicator Systems that can give faster results with assured accuracy:
• 3M Biological Indicator Systems have set the benchmarks for speed with 24 mins for Steam and H2O2 in the same incubator, 4 hours for EO
• Check if your Biological Indicator system can detect non-activated or incorrectly inserted BIs, reducing chances of false negative result
To avoid operator errors, the BI System should be fail safe:
• Detect non-activated or incorrectly inserted BIs, reducing chances of false negative result
• Error alerts to make troubleshooting easy
• Optional visual pH color change result
Compliance with the requirements of FDA/ISO 11138-1:2006, 11138-2: 2006 and 11138-3: 2006 and having certifications like BSI can assure the user of the quality, consistency and the safety of the BI System.
With 3M™ Attest™ Super Rapid Readout Biological Indicators you can get biological indicator results for pre-vacuum steam sterilisation cycles in just 24 minutes (about the time it takes to cool a load). For faster sterility assurance and peace of mind in record time, rely on the 3M™ Attest™ Super Rapid Readout Biological Indicator System.
3M™ Attest™ Super Rapid Readout Biological Indicator Systems are not only built for speed, they help maintain accuracy standards that are critical to the process of sterilisation. You may have heard that all Super Rapid Biological Indicators are the same. Perform the same. Read the same. Give the same assurance. It is important to understand the differences that can impact the outcome of your quality assurance system and potentially compromise patient safety. When selecting a Super Rapid Biological Indicator, make sure that you review the features of the system, and that its implementation is easy and seamless for your team.
Pack monitoring products verify whether sterilant has penetrated to the area where the Chemical Indicator (CI) was placed within the pack. These Type 4, Type 5, or Type 6 chemical indicators (as defined by ISO 11140-1:2014) are designed to react to two or more of the critical variables required for sterilisation to occur—for steam sterilisation, the critical variables are time, temperature, and the presence of steam.
Only Type 5 Integrating Indicators measure all three critical variables and correlate with a biological indicator at three time/temperature relationships under ideal steam sterilisation conditions. It is a best practice to use a Type 4, Type 5, or Type 6 Pack Monitoring Chemical Indicator inside every pack.
Simple to use and easy to interpret, 3M™ Comply™ SteriGage™ Steam Chemical Integrators feature a “moving front” style readout for straightforward “Accept” or “Reject” results. This Type 5 Integrating indicator correlates to the performance of a biological indicator at three time/temperature relationships under ideal steam sterilisation conditions.
An internal chemical indicator such as the 3M™ Comply™ SteriGage™ Chemical Integrator should be placed inside each package in the area, or areas, that are most difficult for sterilant to penetrate. Always read and understand manufacturers’ instructions for use (for the chemical indicator, device, and/or container).
• Compliance with the requirements of FDA/ ISO 11140-1:2014 and having certifications like BSI can assure the user of the quality, consistency and the safety of the CI
• Compliance to ANSI/AAMI/ISO 11140-1:2014 requires a Type 5 CI the correlate with a biological indicator at three time/temperature relationships (i.e. 121°C, 135°C, and at least one temperature in between) and the manufacturer should provide the corresponding stated values with the product on the product/ packaging/ instructions for use
• In addition, the stated value at 121°C must be greater than 16.5 minutes
To provide more accurate information about effectiveness of sterilisation process, CIs should:
• Monitor all three critical parameters (Time, temperature, and the presence of saturated steam). Only Type 5 and Type 6 CIs monitor this
• Have multiple stated values are equivalent to, or exceed the performance requirements for biological indicators. Only Type 5 CIs meet this requirement
It is also recommended that you choose a Chemical Indicator that can be used across multiple sterilisation cycles from 121˚C-135˚C eliminate the need to identify correct Type-6 cycle-specific indicator.
Using a Type 5 CI reduces your chemical indicator inventory and also makes the results more reliable.
It is recommended that you choose a Chemical Indicator that can be used across multiple sterilisation cycles from 121˚C-135˚C eliminate the need to identify correct Type-6 cycle-specific emulating indicator and reduces your chemical indicator inventory and also makes the results more reliable.
Equipment monitoring reveals whether or not your steriliser is doing its job properly. For monitoring vacuum-assisted steam sterilisers, begin each day with a 3M™ Comply™ Bowie-Dick Plus Test Pack. The test is designed to detect air leaks, inadequate air removal, inadequate steam penetration, and the presence of non-condensable gases — any of which can compromise sterility.
Designed for dynamic-air-removal sterilisers, the Comply Bowie-Dick test pack is used to measure the efficacy of the vacuum system in removing air from the steriliser chamber and detect leaks in the system.
The 3M™ Comply™ Bowie-Dick Plus Test Pack is designed to evaluate the effectiveness of the air removal system in pre-vacuum steam sterilisers and to detect residual air in the chamber. A uniform color change to dark brown/black is a PASS. A non-uniform color change showing a lighter-coloured area in the center of the test sheet is a FAIL, indicating residual air in the steriliser chamber. We’ve created a chart to help with interpretation of the test results.
Know at a glance whether packs have been exposed to the sterilisation process with our easy-to-read exposure monitoring products. Our exposure monitoring indicator tapes and labels provide clear evidence that packs have been processed. These process indicators undergo a colour change when exposed to sterilant.
For best results, always place a Type 1 Process Indicator on the outside of every pack, wrapped tray, container, or peel pouch, unless the internal chemical indicator is readily visible.
3M™ Comply™ Indicator Tapes 1322 and 1355 are exposure monitors that not only seal packs securely, but also provide at-a-glance visual assurance that the package has been exposed to the steam sterilisation process. They are Type 1 Process Indicators (as defined by ISO 11140-1:2014) and their purpose is to differentiate between exposed and unexposed packs.
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