Module 14: Design Development and Certification of Medical Devices

17/11/2023

VAPORISED HYDROGEN PEROXIDE (VHP)

● AS WITH CD… suitable for items that cannot be sterilised at high temperature and under steam – Slower than STEAM : can range from hours to days – Less penetrative than ETO – Due to its low (25° to 50°C) temperature conditions, VHP suitable for medical devices with embedded electronics. – However, the vacuum may not be acceptable for embedded batteries

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

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HYDROGEN PEROXIDE PLASMA (HPP)

● AS WITH VHP… suitable for items that cannot be sterilised at high temperature and under steam

– FASTER – 1 to 3 hours / AERATION is not required.

– Although the low (40°C to 65°C) process temperature is appealing, the 13.56MHz RF energy in the range of 200W to 400W during the plasma discharge phase is problematic for embedded electronics.

– CANNOT be used for objects containing semiconductors.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

28

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