Requirements of Aseptic Processing and Filtration

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 3-hour accredited training introduces both new and existing employees to the requirements of aseptic processing preparation and filtration of solutions. The webinar describes the factors, steps, principles, applications and working mechanisms of filtration sterilization while comparing and contrasting the different types of filtration processes and types of filters used for filtration of solutions during sterile drug manufacturing process. The attendees will also gain an understanding on the process steps required to validate the filters used for sterile filtration of products as defined by regulations using Brevundimonas diminuta. This webinar will provide attendees detailed regulatory agencies’ expectations on the use and validation of different types of filters and their respective roles in today’s manufacturing activities.

THIS TRAINING IS PART OF OUR STERILIZATION PROFESSIONAL CERTIFICATION

• To enroll into the complete Sterilization Professional Certification Program CLICK HERE. This program includes 10 specific online courses for $3395.
• To learn more about our certification programs, visit our website at Certifications 

To register for this individual course ONLY, click the Register Now button below.