PDA 443.1 Technical Report No. 3: Validation of Dry Heat Processes
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This training course focuses on the microbiology and principles for qualification of dry heat sterilization and depyrogenation processes as well as the general approach to sterilization and depyrogenation science in batch and continuous sterilizers (ovens and tunnels). Current industry practices and approaches to validating dry heat depyrogenation processes will be covered in addition to various aspects of dry heat as a sterilization process. Points to consider in equipment design, equipment verification, process development and performance qualification for new systems and the development and validation of processes for existing systems will also be discussed.
Participants will understand equipment options and the factors for consideration in qualification, validation and ongoing maintenance. During this training course, participants will learn about the use and limitations of endotoxin indicators and biological indicators and the calculations used to determine inactivation of both types of challenges. Participants will have an opportunity to discuss actual problems encountered and consider causes and possible solutions.
Upon completion of this training course, the attendee will be able to:
- Explain the concepts and methods in the validation of dry heat processes
- Discuss current industry practices and approaches to validating dry heat depyrogenation processes
- Identify load type, loading patterns and temperature profiles for depyrogenation and sterilization
- Interpret results and adjust or problem shoot as necessary
- Demonstrate competence in ability to conduct successful validation of dry heat processes
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Standard Pricing
Standard Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
AcademicMember Only
$599
Non-Member
$599
Featured Presenters
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Deborah Havlik
DAHavlik Consulting
Read Bio
Deborah Havlik
DAHavlik Consulting
Deborah Havlik has been working as an independent consultant with expertise in microbiology and sterilization for the past four years. Prior to that, she was the Director of R&D Microbiology in Pfizer and was responsible for supporting the development of microbiological test methods and sterilization processes for drug products, biologics and combination products globally. Deborah has industry experience working in device, contract sterilization/contract laboratory and pharmaceutical companies. She has developed sterilization processes in ethylene oxide, moist heat, dry heat and radiation and also evaluated novel sterilization technologies. She is active with the Parenteral Drug Association and with AAMI and ISO on multiple working groups developing sterilization standards, and is a member of the USP Small Molecules 1 Expert Committee.
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