Module 14: Design Development and Certification of Medical Devices

17/11/2023

X-RAY STERILISATION

● The least used radiation technology.

– Gamma and EBS are optimised for bulk continuous sterilisation, where the throughput and sterilisation time must be as short as possible. – High-energy X-ray technology has some safety implications when optimised in this bulk processing format due to the extra shielding required.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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Not strictly sterilisation… ASEPTIC PROCESSING

● Filter sterilisation

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

42

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