Module 14 2022

22/03/2022

GAMMA STERILISATION

● STERILISATION – TYPICALLY TAKES PLACE AT ELEVATED ROOM TEMPERATURE AND NORMAL ATMOSPHERIC PRESSURE

MEDICAL DEVICE SOLUTIONS AND GELS: TYPICAL DOSE: NLT 25 to NMT 38 KGy

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

35

GAMMA STERILISATION

● EFFECTS – Besides affecting living cells, gamma radiation also affects polymers and semiconductors. – The effect on electronics depends on the dose and dosage rate. In the extreme, a total ionisation greater than 5000 rads (0.05 KGy) in silicon delivered over seconds to minutes degrades semiconductor materials for long periods. – In practice, the medical industry, for example, sterilise instruments and products at ionization levels in the range of 250 to 500 rads range (0.0025 – 0.005 KGy), where specifically design semiconductor devices can reliably operate. – under the right conditions, gamma ray sterilisation can be used for objects containing compatibly-designed semiconductor devices.

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

36

18