Medical Device Sterilization with FDA Complimentary Learning Level: Intermediate/Advanced Session Length: 1 hour The most commonly used method in the U.S. to sterilize medical devices is ethylene oxide (EtO), and it is widely...
Complimentary
Learning Level: Intermediate
Session Length: 60 minutes
Health authorities and regulators are increasingly looking for much higher levels traceability during the manufacture of parenteral medicines. The most common processes and technologies applied to achieve compliance are now reaching their technical limitations and as such new approaches are needed to deliver the traceability requirements,
Traceability at the individual container level could become very important to drive patient safety through the prevention of product mix-up. There are other strong business drivers for uniquely coded containers. These include improved batch visibility and accountability whilst simplifying investigation work in case of potential deviations during fill and finish operations. This reduces risk and can limit the direct financial impact from missed revenue or drug shortages.
Learning Objectives
- Outlining the concept of primary container traceability
- Key operational benefits
- Creating an industry standard
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