Cleaning, Sanitization, and Qualification of Disinfectant Efficacy for Cell Therapies

Description:

A webinar to provide guidance for having a sound disinfectant and sanitization program that is required for controlled environments used in the manufacture of cell therapy products and other HCT/Ps to prevent microbial contamination.

This 90 minute program is designed to help build technical knowledge in the best practices for cleaning and sanitization of controlled areas in order to control contamination. This program is also designed to build knowledge of how to design disinfectant efficacy studies that will satisfy cGMP/GTP regulatory expectations.

Why Should You Attend?

In this training you will be able to understand the differences between cleaning, sanitization, and disinfection; and differences in disinfectant agent effectiveness. Learn how disinfectants are classified, the scale of microbial and virucidal resistances, and modes of activity of common agents that are used in industry. Understand the elements involved in surface decontamination and the proper procedures and technique. Learn the answers to the following questions:

  1. How are the two-bucket and three-bucket systems used and what’s the difference?
  2. What is the proper sequence for sanitization of controlled areas?
  3. What contact times are often used?
  4. What is the sanitization frequency for controlled areas?
  5. How do you clean/sanitize Biological Safety Cabinets?
  6. What are the acceptance criteria for disinfectant and sporicidal efficacy studies?
  7. How do you select appropriate challenge strains to be used?

The information presented should help cell therapy and other HCT/P manufacturers to gain a better understanding of best industry practices in disinfection and sanitization programs for clean rooms, BSCs, and other controlled areas; and understand the regulatory expectations for sound disinfectant efficacy studies.

Key Topics:

  • Guidance and regulatory requirements, including examples of warning letter observations
  • Definitions and meaning of terms
    • Cleaning and cleaning agent
    • Sanitization and sanitizing agent
    • Disinfectant vs. Sporicide vs. Sterilant
  • Microorganism types and resistances
  • Modes of activity
  • Procedures
    • 2-bucket and 3-bucket systems
    • Stroke patterns
    • Sequence and frequency
  • Cleaning Biological Safety Cabinets
  • Disinfectant Efficacy Testing
    • Selection of challenge strains and isolates
    • Use-dilution
    • Contact times
    • In-vitro coupon study design
      • Surfaces
      • Application
      • Neutralization and recovery validation
      • Acceptance criteria
      • Log reduction values

Who will benefit?

Laboratory Cleaning or Housekeeping Staff, Facilities, Quality Control, Quality Assurance, Validation, Regulatory

Instructor Profile:

Timothy D. Wood has over 25 years experience in Quality Control Microbiology in cGMP industry. Tim is founder and Principle Consultant at Cell Therapy Microbiology Consulting designed to assist the cell therapy industry in developing and improving microbiology methods and contamination controls. For over 13 years Tim was at Dendreon helping to get the autologous cellular therapy product PROVENGE through pivotal trials, FDA approval, and expanded to multiple cGMP facilities. Tim was responsible for the development of microbiological policies, environmental monitoring programs, and microbiology and aseptic training programs. Tim has worked as a Microbiologist at several companies including ICOS, Xcyte Therapies, CellPro, and Abbott Laboratories. Tim received his Bachelors degree in Biology from Pacific Lutheran University, Tacoma, WA.