Overview of Pharmaceutical Thermal Sterilisation
This course provides an overview of the principal moist and dry heat sterilisation processes used in pharmaceutical and biopharmaceutical manufacturing, including types of equipment employed, such as porous and fluid load autoclaves, sterilise in place (SIP) systems, batch ovens and depyrogenation tunnels, typical routine controls and testing requirements, equipment qualification/requalification and process validation activities. The course discusses overkill or bioburden based cycle design and the rationale why either may be selected. This course is aimed at individuals involved directly or indirectly in managing, operating, qualifying and maintaining thermal sterilisation equipment or validating thermal sterilisation processes. Target disciplines include microbiology, production (operators, supervisors and management), quality assurance, validation, technical support and engineering.
Presenter: John Welbourn