Requirements for Aseptic Techniques and Practices

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 the basic requirements and steps of proper aseptic practices and sources of contamination within cleanrooms and Quality Control testing environments. This webinar provides preliminary understanding of the basics of microbiology and the requirements of cleaning & disinfection as it relates to contamination control requirements. Participants will be able to apply the 4 Pillars of Aseptic Techniques, Cleanroom Behaviors and Practices within product manufacturing and testing Cleanrooms and Clean zones.

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

• Summarize the requirements of proper aseptic practices within cleanroom and testing operations
• Define the basic microbiological requirements as it affects cleanroom contamination and controls
• Apply the basics of cleaning and disinfection to proper aseptic practices and contamination control
• Identify and apply the four (4) pillars of aseptic techniques
• Distinguish between aseptic techniques and cleanroom/cleanzones behaviors and practices

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.