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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