Cleanroom, Microbiology and Sterility Assurance Practices for Sterilization Processes

Charity Ogunsanya

Course description

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483’s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process.

This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations which may negatively impacts a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance with the impacted systems.

This accredited training introduces both new and existing employees to Cleanroom Regulations and Basic Background as well as the proper way to Design, Qualify/Validate and perform routine monitoring of Cleanrooms per ISO 14644-1 through ISO 14644-4.

This webinar will educate the attendees on establishing a robust Environmental Monitoring, Personnel Training, Aseptic Practices, Cleanroom Behavior, Cleanroom Trafficking and Cleanroom Gowning programs for an effective Cleanroom Contamination Control program. This webinar will provide guidance to attendees on the basics of microbiology and how to establish a robust Cleanroom Cleaning and Disinfection Program, its application to contamination control and sterility assurance requirements as well as its role in today’s manufacturing activities.

Upon completion of this course, you will be able to:

• Define Cleanroom Regulations and Basic Background
• Establish the proper Design, Qualification/Validation, Cleaning Validation and Routine Monitoring of Cleanrooms per ISO 14644-1 through ISO 14644-4
• Apply the requirements of Environmental Monitoring Program, Personnel Training, Aseptic Practices, Cleanroom Behavior, Cleanroom Trafficking and Cleanroom Gowning to an appropriately designed Cleanroom Contamination Control program
• Establish a robust Cleanroom Cleaning and Disinfection Program and its application to contamination control and sterility assurance requirements
• Define the Basics of Microbiology and Contamination Control program requirements
• Identify the FDA’s view of an appropriate contamination control and sterility assurance program based on the review of Compliance Expectations, FDA Form 483’s, and Case Studies

This training is part of the 10-course series required for the Cobblestone Sterilization Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.