assessing sterilization criteria
 Requests for sterilization fall into three categories:
- Product that requires the use of a validated sterilization process; this category includes all devices that are ready for long term multi-lot production.
- Product that requires sterilization, but only a single lot is to be produced; sterilization is accomplished through an abbreviated process.
- Product that requires an “Exposure Only,” intended to facilitate decontamination (a reduction of the bioburden). Exposed product will not be labeled as ‘Sterile’ following processing; bioburden reduction assessment or BI monitoring is available. Exposure Only jobs must include this form (PDF file).
Knowledgeable and experienced personnel are available to discuss the intended use, design and material composition of your product to assist in determining the extent of processing required.
Validation Studies are performed according to the following standards:
Ethylene Oxide - ANSI/AAMI/ISO 11135, EN 550
GAMMA - ANSI/AAMI/ISO 11137
Multi-Lot Sterilization:
If you plan to produce two or more lots over a period of time, then a validation procedure is required that not only demonstrates sterilization efficacy, but also shows that the sterilization process is reproducible. Methods of validating a cycle are outlined in the reference documents listed above. Ethox STS can design a cycle to accommodate most product or packaging restrictions, while adhering to the requirements of the guidelines.
It is good practice to test product and packaging functionality following exposure to two full cycles in the event that dual exposure becomes necessary. In the case of EO processing, this means that the EO residuals can be reduced to acceptable levels by aeration. For all types of processing, it also means that the product and packaging remain functional.
Single Lot Sterilization:
First, overkill sterilization must be shown by running a half cycle in which no survivors from the microbial challenge are detectable.
Second, the product will be exposed in a full cycle. The product from this single lot may be released following the half/full cycle and successful completion of any required post-processing tests (see below).
Release of subsequent lots would require that a complete validation study be done.
Exposure Only for Purposes of Decontamination (Bioburden Reduction)
Sterility Not Assured:
If sterilization is not required for your medical device, Ethox STS can design and provide a process suitable for your application. Materials can be treated with ethylene oxide or steam. In this process your product will be exposed under conditions that are often similar to those used for sterilization. The choice of these conditions will be based upon our experience with similar products. If sterility is not a requirement, the product will be labeled "Sterility Not Assured" at the conclusion of processing. Exposure Only jobs must include this form (PDF file).
Testing after processing may include:
• Ethylene oxide residual testing
• Biocompatibility testing
• Package Integrity testing
• Product Functionality testing
• Toxicology testing
• Accelerated Aging studies
certifications
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To learn more call Jason Voisinet at 716-842-4000 x283 or e-mail us! |
