Cleanroom, Microbiology and Sterility Assurance Practices

Charity Ogunsanya

Course description

This intensive course provides attendees a comprehensive knowledge about the A-Z of Sterility Assurance which is based on regulatory requirements, FDA guidance, compliance expectations, and industry practices. Key elements of sterility assurance and contamination control starts from creating a robust and compliant cleanroom design, validation/qualification, operations, environmental monitoring program requirements, microbiological processes/methodology, cleanroom cleaning/disinfection, trafficking, gowning requirements, and contamination control will be extensively discussed.

Other key aspects of achieving product sterility such as a good understanding of the basics of sterilization processes–physical and chemical processes and the various examples of sterilization equipment and their specific process parameters will also be discussed. Critical regulations affecting Sterility Assurance requirements such as 21 CFR Part 211, ISO 14644 (various parts), ISO 11135, 11137, 11138, 14160, 14937, 17664, 17665, FDA Guidance for Industry, and other regulations guiding these critical topics will be covered.

Discussions will include the criticality of aseptic processing and other key contamination control evaluators during the manufacture and testing of products.

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

• Explain the detailed requirements of the various cleanroom classifications per ISO 14644 and expectations based on the regulations and guidelines.
• Apply best practices in the design of a new cleanroom through qualification/validation, operation and routine environmental monitoring program.
• List FDA and regulatory guidance and expectations on aseptic and personnel health practices, gowning and trafficking patterns within a cleanroom.
• Apply industry guidance and the requirements of how to create a robust cleanroom cleaning/disinfection and contamination control programs to achieve a high degree of sterility assurance.
• Explain in detail the two types of sterilization processes with detailed description of each type, parameters as well as their advantages and disadvantages.