All biological indicators supplied and used in testing will be enumerated prior to conducting testing, to ensure suitability for use. 1 mL Spore & 0.4 mL Mini Spore Ampules are self-contained Biological Indicator (BI) ampoules for monitoring steam sterilization of liquids, such as media. We routinely offer validation and commissioning studies using BIs, particularly on autoclaves. Part 1 VOL 14, ISSUE 2 The MeCo Solution: Improving Consistency, Accuracy and Robustness in SIP Validation VOL 14, ISSUE 1 Sub-culturing a Positive Biological Indicator for Identification VOL 13, ISSUE 3 Biological Indicators and the European Pharmacopoeia VOL 8, ISSUE 2 The Problem with EP 7.0, 5.1. Biological monitoring manages sterilization with the use of bacterial spores. Sartorius Adapter Rings for Sterisart Sterility Testing Systems. We can also assist you with BI troubleshooting along with purchasing and supplying the BIs and any other media required for testing, whether conducted by ourselves on your behalf, or for in-house routine use. Duo-Spore Biological Indicator Test for weekly or daily sterilizer monitoring and for. An example of this is our recent involvement in the publication of a joint study. Generally speaking, sterilizer monitoring should include a combination of mechanical, chemical, and biological monitoring. Our technicians have also assisted with bespoke BI production and enumeration projects, in order to determine susceptibility of a wide variety of microorganisms to decontamination processes as part of proof of concept work, publications and end product manufacturer claims. We perform all of the standard methods of biological indicator testing, with many BI types including paper strips, stainless steel discs and a variety of self-contained BIs. BIs consist of a standardised and homogenous population of bacterial spores that vary in type or number, depending on the sterilisation or contamination method in question, but are typically a 6-log population of Geobacillus stearothermophilus and Bacillus atrophaeus, with known resistance to the mode of sterilisation being monitored, (so called D-value). These processes include, but are not limited to, moist heat, dry heat, ethylene oxide sterilisation, low temperature steam and hydrogen peroxide vapour decontamination.
Biologic spore testing iso#
The requirements and performance specifications of biological indicators (BIs) used to verify sterilisation or decontamination processes are set out in ISO 11138 series (Sterilization of Healthcare Products – Biological Indicators).
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