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Category: EO & Steam Sterilization Validation
The Sterilization Section specializes in the industrial sterilization of medical devices. This includes those sterilized using ethylene oxide, vapor phase hydrogen peroxide, steam, and radiation.
[ more ]Tests available for EO & Steam Sterilization Validation
Steam sterilization validation ISO 11134
Ethylene oxide (EO) sterilization ANSI/AAMI/ISO 11135, EN550
EO cycle development ANSI/AAMI/ISO 11135, EN 550
Biological indicator sterility test ISO 11135
The number of BIs should be based on ISO/EN recommendations regarding usable chamber volume of the sterilizer or product load size (proposed under new revision of ISO11135). Contact Nelson Laboratories for details. Please notify the laboratory when weekend delivery of biological indicators is expected. Studies that come in over the weekends will be charged STAT pricing. Specific courier and tracking information is appreciated.
A minimum report fee of $100.00 applies to BI sterility tests (standard BIs).
A minimum report fee of $75.00 applies to BI sterility tests (self-contained BIs).
Biological indicators to purchase
Nelson Laboratories, Inc., is a distributor for Getinge/Castle, Inc. sterilization monitoring products. The product line offers an advantage to manufacturers because of their 510(k) approval for biological indicators that only requires five day incubation.
Biological indicator sets are available for monitoring steam, ethylene oxide, and dry heat sterilization processes. The set includes biological indicators and the special media required for grow out. Nelson Laboratories holds the media on reserve for clients who do their BI sterility testing at Nelson Laboratories.
EO exposure cycles
Exposure cycles are intended for feasibility, functionality, biocompatibility, etc. If requested, product can be preconditioned up to 24 hours in an environmental chamber. Please specify temperature between 40-49°C and between 45-65% relative humidity.
EO residuals/VHP residuals AAMI/ANSI/ISO 10993-7, AAMI TIR 19-1998, USP 28
Ethylene oxide (EO) gas sterilization is a dependable and effective method of sterilizing heat and/or moisture sensitive devices. Additionally it provides the following benefits:
- Materials can be prepackaged, then sterilized and maintained sterile until used.
- Ethylene oxide is relatively non-corrosive to plastic, metal, or rubber materials.
- Sterilization parameters may be monitored to ensure effectiveness and to distinguish processed from un-processed materials.
In an effort to insure that levels of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) pose a minimal risk to the patient in normal product use, exposure limits have been set. Established limits by ANSI/AAMI/ISO make analysis of EO residuals mandatory. Nelson Laboratories analyzes for ethylene oxide, ethyl chlorohydrin, and Ethylene Glycol (EG) using state of the art gas chromatographs.
Nelson Laboratories places EO residual samples on test within 24-48 hours. This is contingent upon receipt of a completed sample submission form and extraction specifics form (weekends excluded).