Now suppose that several more packs are recalled within a short period of time and a pattern of failure begins to develop. You need to find the origin of the problem. If you’ve been keeping good records, you should be able to trace each pack backward through the levels of monitoring control to the sterilization event itself. This will make it much easier to diagnose the problem. It’s important to note that by using a BI for Load Control in every load, tracing your steps becomes much less complicated. Yet another good reason to get in the habit of using a rapid readout BI in every load and quarantining until the BI results are available.1 Each pack should be labeled so it can be traced back through records in the event of a problem.
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Documenting the evidence in sterilization process monitoring24 This is a lot of information to digest. So, to sum up, here are the basics of what you need to do to maintain the most complete and successful sterilization process monitoring program, followed by a chart you can use as a handy reference. We hope this has been helpful. THE BASICS For the best results, use a rapid readout biological indicator in each load (Load Control); a chemical indicator inside each pack (Pack Control); a chemical indicator outside each pack, tray, container or peel pouch (Exposure Control); a Bowie-Dick test pack each day in each vacuum assisted sterilizer, read and record the mechanical monitors on the sterilizer, use a chemical integrator test pack in each load not monitored with a biological indicator (Equipment Control); and record all the monitoring results in a record keeping system (Record Keeping).
VALIDATION OF STERILIZATION PROCESS Control devices for sterilization: Are devices to insure a good sterility status 1- Indirect: monitoring the sterilization process by the use of physical, chemical, and microbiological indicators 2- Direct: monitoring it microbiologically through sterility testing A- Physical indicators: 1- Dry heat: by recording temperature and time during the process 2- Moist heat: monitoring pressure and temperature 3- Ethylene oxide: monitoring pressure, humidity, and temperature 4- Radiation: recording the absorbed radiation dose B- Chemical indicators: 1- Browne’s tube: ampoule containing certain chemical which change in color at certain temperature 2- Witness tube: sealed tube containing a compound that melts at sterilization temperature e.g. sulfur at 115°C 3- Paper strips: stickers which change in color during sterilization forming letters writing the word STERILE C- Biological indicators: By the use of a highly resistant MO which is tested at the end of the sterilization process for viability. The most commonly known is Bacillus stearothermophilus for validation of sterilization process in an autoclave. STERILITY TESTING Required for all injectables and ophthalmics. It is considered as a final control on sterilization. It is not important except in case of filtration. It is a destructive test i.e. samples tested are not reused. It tests that samples are free form bacteria and fungi, but not viruses. Batch: group of articles which are exposed to the same conditions i.e. prepared, mixed, packed and sterilized together. Sample size: Two percent of the batch with maximum 20 articles selected randomly Culture media for sterility testing: a- Fluid Thioglycolate Medium (FTM) for detection of both aerobic and anaerobic bacteria b- Trypticase Soya Broth (TSB) which supports both fungi and aerobic bacteria. General sterility testing procedure 1-Direct Inoculation In the direct inoculation method, the test articles are inoculated directly into tubes or bottles that contain an appropriate medium and are incubated for a period of 14 days.