Using dose substantiation to attain a sterility assurance level
When a product or device’s basic function is to improve the health of others, you need to be certain that it’s as free of contaminants as possible. At C.G. Laboratories, we know that making sure your product is safe is your highest priority. Quarterly Dose Audits are essential to that process. We work with you to streamline the experience to make your Quarterly Dose Audits (QDA) as painless as possible.
You’ve already established a sterilization dose that meets the requirements for sterility for your product type. Its specified Sterility Assurance Level (SAL). If not, we can assist you with that as well. This minimum dose needed to achieve sterility must be monitored on an ongoing basis. For most manufacturers that is quarterly.
Why is this necessary?
Bioburden can shift and change over time. Microorganisms such as bacteria, viruses and spores could be surviving the sterilization process. You must demonstrate that your sterilization dose can be delivered consistently and that it’s effective. Regular Quarterly Dose Audits will detect shifts in bioburden counts not only in the number of microorganisms, but also if they are becoming more resistant to the sterilization process. Any changes in manufacturing procedures or environment including, raw materials, components, equipment, product design, air quality and even personnel can alter bioburden and could also require an immediate need to complete a dose audit.
C.G. Laboratories, your partner to provide full-service Medical Device Testing, Decontamination & Contract Packaging. Our experts work with you to offer comprehensive solutions for all of you Quality Assurance needs. We provide services that are customizable and flexible to fit your specifications and timelines. You get direct access to our intellectual capital when you use our consultative services.
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