PDA 468.2 Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control
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This live eLearning training course is based on PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control. Since its issuance, it has been widely utilized by industry and regulatory sterilization professionals in the development and assessment of sterilization programs across the globe. This training course will provide a foundational understanding of sterilization science (microbiology and thermal science) that will then be applied in the selection of a cycle design approach, sterilization process development, process performance qualification and ongoing process control.
Moist heat sterilization processes are considered to be "special processes" since the output of the process, product sterility, cannot be fully verified with test methodologies such as the sterility test. Therefore, it is absolutely essential that moist heat sterilization processes be properly designed, validated and controlled. Important moist heat sterilization topics also covered by this training course include:
- Application of key terms including D-value, z-value, physical (F0), biological lethality (FBIO), Spore Log Reduction (SLR), Probability of a Non-Sterile Unit (PNSU), steam quality and equilibration time
- Considerations in the use of steam and water requirements for moist heat processes
- Fundamentals in the selection and use of biological indicators and chemical indicators
- Selection of a sterilization process type based on product attributes
- Design considerations for key and critical parameters
- Determination of cold spots
- Practical application of semi-log survivor curve equation in sterilization calculations
- Use the overkill approach and alternates to the overkill approach (product specific approach)
- Use of master site and master solution approach
- Use of bracketing approaches to optimize process qualification activities
- Sterilizer suitability and equivalency
- Parametric release of moist heat sterilized products
- Impact assessment for product, process, and sterilization equipment modifications
Participants will also receive a free copy of PDA Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.
Upon completion of this training course, the attendee will be able to:
- Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
- Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type
- Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
- Assess risk associated with the cycle phases and identification of key and critical process parameters in the development of the sterilization process for liquid and porous/hard goods loads types
- List the critical elements of process performance qualification
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Standard Member Price
$599GovernmentMember Only
$599
Health AuthorityMember Only
$599
AcademicMember Only
$599
Non-Member
$599
Featured Presenters
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Mike J Sadowski
Lead Scientist, Baxter
Read BioMike J Sadowski
Baxter
Michael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation. He is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of glboal pharmaceutical and medical device products. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization modalities. In addition to participation on the Task Force for the revision of PDA TR No. 1 on Moist Heat Sterilization, he was the Chair of the Task Force for the revision of the PDA TR No. 30 on Parametric Release. Mike previously served as Treasurer, Secretary and Director on the PDA Board of Directors and member of the PDA Scientific Advisory Board and currently serves an Associate Editor for the PDA Journal and Co-Chair of AAMI WG 03 on Moist Heat Sterilization. He has successfully aligned industry and regulatory agencies to shape best practice and continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. He is frequently sought as an expert speaker by global industry and regulatory Sterility Assurance professionals. Mike received his BS Degree in Microbiology from Purdue University.
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