Module 14 2022

22/03/2022

HEAT STERILISATION

– DRY HEAT: Not widely used for medical devices

– Heating at very high temperatures for a long time (e.g. 160°C for 2 hours)

– Used for heat-resistant products – such as metal devices or powders

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

11

STEAM moist heat sterilisation (ISO 17665-1:2006)

● Destroys microorganisms by the irreversible coagulation and denaturation of enzymes and structural proteins

Various processes available, e.g.: – Saturated steam venting systems – Saturated steam active air removal systems – Air stream mixtures – Water spray – Water immersion

Masterclass: Lecture 11

The Organisation for Professionals in Regulatory Affairs

12

6