2022 - Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

OVERVIEW
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement.
This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail.
WHY SHOULD YOU ATTEND?
A review of the different filtration media is provided with the construction characteristics and properties of each detail. A detailed description of a typical pharmaceutical sterile filtration system with its individual components is provided. Engineering schematics are included. Microbiology and particle retention mechanisms are discussed.
Integrity testing methods are detailed as well as media qualification. Procedures for the sterilization of the filter are presented (SIP, autoclave, etc.).
The proper validation of sterile filtration is important to ensure that the filter will reproducibly remove undesirable components (bioburden) while allowing passage of desirable components (drug product). The operating parameters of time, pressure, and temperature are fully discussed as well as the filter's potential effect on the product (compatibility, leachables, fibers, endotoxin, etc.). Microbial retention challenge testing is one of the validation requirements.
Finally, a compilation of all FDA/EU GMP regulatory guidances concerning sterile filtration are presented. Related to this; the responsibilities of the filter manufacturer vs. the filter used are fully discussed.
AREA COVERED
Sterile filtration - Importance of Quality
Sterility Assurance of Sterile Filtration
Sterile Filtration System Design
Discussion of Different Filtration Media Properties and Retention Mechanisms
Methods for Sterilization of Filters
Validation of Sterile Filter Systems
Microbial Retention Challenge Testing
Integrity Testing
Product Compatibility Testing
Extractable/Leachable Testing
Regulatory Requirements
WHO WILL BENEFIT?
Quality Assurance
Environmental Monitoring
Microbiology
Manufacturing
Validation
Engineering
Maintenance
SPEAKER PROFILE
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 37 years experience in pharmaceutical quality assurance and manufacturing.
For more detail, please click on this below link:
https://bit.ly/3tiHJD4
Email: info-AT-247compliance.us
Tel: +1-661-336-9555
https://www.linkedin.com/in/whitney-jones-87357317...