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PDA 468.2 Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Validation and Ongoing Control

Jul 27 - Jul 28, 2023
9:00 AM
-
12:00 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online
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Overview

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.

For more options and/or related training courses, please visit the page(s) below.

PDA Sterilization Training Courses

Agenda

  • Day 1
  • Day 2

  • Welcome and Introductions (15 min)

    Sterilization Science I: Microbiology (75 min)

    Break (15 min)

    Sterilization Science II: Thermodynamics and Steam Quality (60 min)

    Wrap-Up / Q&A (15 min)

  • Day 1 Recap / Q&A (15 min)

    Moist Heat Sterilization Process Development (75 min)

    Break (15 min)

    Process Performance Qualification and Ongoing Control (60 min)

    Wrap-Up / Q&A (15 min)

Trainers

Mike J. Sadowski
Mike J. Sadowski
Baxter Healthcare
Bio
Mike J. Sadowski
Baxter Healthcare

Michael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation in Round Lake, Illinois. He is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of sterile products across the globe. Mike has 30 years of experience with drug and device sterilization with a variety of sterilization methods including moist heat, ethylene oxide, radiation, and aseptic processing. In addition to participation on the Task Force to revise PDA TR No.1 on Moist Heat Sterilization, he was the Chairman 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 Director and Science Advisory Board Member and is currently a member of the Education Advisory Board. Within these roles, he has successfully brought industry and regulatory agencies together to shape best practice and guidance. Mike continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. Mike received his BS in Microbiology from Purdue University in West Lafayette, Indiana.

Learning Objectives

  1. Discuss microbiology and sterilization science and apply these concepts in the development of a scientifically sound and regulatory compliant sterilization program
  2. Use a decision tree to select the most appropriate sterilization process based on the attributes of the load type
  3. Utilize the semi-log survivor curve equation in support of the development and ongoing control of the sterilization program
  4. 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
  5. List the critical elements of process performance qualification

Who Should Attend

This training course is intended for professionals who are involved in the development and assessment of sterilization processes used in sterile drug manufacturing.

Departments
  • Quality Systems
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Technical Operations
  • Validation

Roles
  • Analyst
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager
  • Engineer
  • Scientist

Registration Fees

Register Now
Registration Type Price
All Participants $599

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