Sterilization Technologies and Process Validation
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Who Should Attend
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Description
This course will examine the four major methods of sterilization
available to the medical device, diagnostic and pharmaceutical
industries. Steam, ethylene oxide, filtration and radiation sterilization
will be discussed in relation to technique, method selection and
equipment required. The course will also explain the latest systems
in process release of products for cost savings, cost efficiency and
efficient movement from sterilization to the marketplace. The
current and future status of microbiological control of raw materials,
sterilization, and terminal sterilization of finished products will be
covered. The effects on product selection of packaging, sterility
testing and legal aspects will be comprehensively discussed.
Regulatory attitudes on microbiological control, legal requirements
and government approvals will be examined. Faculty includes
expertise in gas, steam, filtration and radiation sterilization,
packaging, sterility testing, governmental regulations, and
compendial requirements.
Current good manufacturing practice with reference to FDA
requirements will be discussed as well as the most recent dose
setting methodologies for dosimetric (parametric) release of
products per the AAMI and FDA standards. The questions asked
will directly bear on the information presented in the manual and will
give you a working knowledge of the principles and techniques
described.