Aseptic Filter Validation School
Two-Day Course
Validation has always been a key aspect of assuring sterility of the final formulation produced under aseptic conditions. As sterilizing-grade filters play a major role in obtaining a high sterility assurance level, validation of these filtration processes has become a subject of increasing awareness and regulatory scrutiny.
The two day course will provide you with in-depth knowledge on the validation of sterilizing-grade filter performance, filtration processes, filter integrity testing procedures and filter sterilization cycles, as well as on documentation for the validation of sterile filtration processes. This training course provides students with an excellent knowledge of the current regulatory guidelines, how to interpret them, and how to translate them into good aseptic processing practice and documentation.
- Filter selection for Aseptic filtration operation
- Interpretation of regulatory guidance with respect to filtration
- Current methods and practices of filter validation
- How to acquit yourself when a regulatory audit takes place in your premises, and how to interpret and answer questions asked by the auditor
- Why Integrity testing, its importance and product wet integrity testing
This two day training program is designed for Engineers and Scientist from the Pharma & Biotech industry involved in Quality Assurance, Validation, Research & Development, Process Engineering and Regulatory Affairs. Prior knowledge of Basics of Filtration and Integrity Testing is highly recommended.
- A copy of the course materials
- A certificate of attendance
- CM1: Regulatory requirements for aseptic filtration
- CM2: Sterilizing-grade filters
- CM3: Validation master plan
- CM4: Filter validation, microbial retention, integrity testing, compatibility,
extractables analysis, adsorption, preservative binding, and redundant filtration. - CM5: Aseptic disposable solutions
The two day course covers the basic theory and practice of filter validation for biopharmaceuticals. The time is evenly distributed between lectures, discussions, workshops and laboratory. To satisfy cGMP requirements, participants will receive a course certificate upon completion.