Estimating the Effects of EtO BIER-Vessel Operating Precision on D-Value Calculations D-values for several ranges of expected BIER-vessel performance have been calculated and compared with a common BI-certificate value. Commercially available biological indicators (BIs) are of critical importance to both the healthcare providers and device manufacturers that perform EtO sterilization. Because it is more easily controlled, radiation sterilization lends itself to parametric release based on chemical dosimeters. For steam sterilization, healthcare providers generally use commercially available BIs, but manufacturers of sterile products may take several other approaches to validation and routine release. Naturally occurring bioburden, BIs derived from resistant bioburden isolates, and commercially available BIs are commonly used for validation, while BIs or parametric release can be used for routine release. However, parametric release is not commonplace with EtO sterilization processes, and most routine release testing is performed with commercially available BIs. In addition, commercial BIs are used to establish microbial-lethality relationships in nearly all EtO process validations. When using BIs for these purposes, device manufacturers are dependent on the certifications performed by the BI manufacturers to assure that their products will meet the appropriate quality system regulation requirements. Such certifications are conducted in specialized test vessels known as biological indicator evaluator resistometers, or BIER vessels. The test requirements for BIs are specified by the , ISO standards, and European norms. Because the certifications are so important, some users attempt to verify the data presented in the certificate, but doing so can be challenging. Not only does verifying certificate values require hundreds of samples and a BIER vessel, but the performance of different BIER vessels is likely to vary, even though they are required to operate within the precise limits defined by the AAMI and ISO standards. Specifically, BIER vessels for EtO must comply with the following steady-state control limits: an
Products & Services
Pressure vessels are boilers and storage tanks that contain liquids or gases and are designed to operate at pressures above 15 psig.
Product and Component Testing Services
Product and component testing services is the evaluation of a finished product or component through performance in electrical, life, environmental exposure, dynamic, ergonomic or other specialized tests. Also testing to standards such as UL 489, CE or MIL-STD 810.
Welding and Fabrication Services
Welding and fabrication services provide customized metal forming and processing, typically on a contract basis. Capabilities are usually not limited to welding and fabrication, and may include design consulting, on-site operations, prototyping, and other useful industrial procedures.
Biological indicators are used to monitor and evaluate the effectiveness of sterilization.
Sanitary fittings are designed and constructed for use in food, beverage, medical, pharmaceutical and biological applications where cleanliness and sterility are required.
Topics of Interest
Calculating Equivalent Time for Use in Determining the Lethality of EtO Sterilization Processes A mathematical model that results in accurate lethality calculations will enable EtO users to optimize...
Medical Device & Diagnostic Industry Parametric Release for Low-Temperature Gas Plasma Sterilization With the possibility of parametric release, low-temperature gas plasma sterilization may be a...
Be in the Know about EtO Expedited processing and better controls amp up the efficiency of ethylene oxide sterilization while revised standards affect validation EOExpress, offered by Steris Isomedix,...
Chapter 12: Definitions
is a population of viable presterilisation micro-organisms in the finished product, raw material, component and/packaging.
Sterilization Methods Stand the Test of Time The development of biological indicators and parametric release has led to improvements in sterilization processes and shifts in industry preferences. Karl...