Filters and Filtration in Aseptic Processes

Including Integrity Testing and Extractable & Leachable Analysis Studies
Lecturer: Mr. Mark Trotter

Date: 26, 27 November 2018
Location: Kfar Maccabiah, Ramat Gan
General Information
Duration: 2 - Day Course
Hours: 09:00 – 17:00
Price: 4,700 NIS + VAT
Credit Points: 1
SKU: 18471
Course Language: English
About the Course
The course will cover form and function of sterilizing and prefilters used in critical aseptic processes.  Topics covered include; various mechanism of particle and microbial removal, pore size ratings, typical filtration process applications and overview on functionality and integrity testing.  Theoretical and practical review of Bacterial Challenge and filter Integrity Testing with ‘Do and Don’ts’ and trouble- shooting provide useful insight into these protocols. The course will review industry standards and regulatory requirements regarding sterilizing & pre-filtration and discuss current trends and developments.  Extractables and leachable filter topics will also cover recent regulatory and industry concerns and guidance.
Who should attend
Course is designed for those with some filtration experienced and may be useful to those new to aseptic biopharmaceutical processes. The course is essential for the need to know current requirements for specifying sterilizing-grade and prefilters in biopharm processes.

Process Development Engineers and researchers/Scientists, Pilot-Plant Staff, Production management and operations, Validation & QA/QC & RA personnel.
Benefits to the Participants
  • Be able to identify process applications for sterilizing & prefilter usage.
  • Understand the concepts of filtration mechanisms in liquid and gases.
  • Determine filtration media uses for various filtration applications.
  • To be able to specify and qualify filters for these applications.
  • Understand Integrity Testing and troubleshooting methods.
Contact us
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Issues to be covered
The Course will review the latest industry filtration technologies and standards with an overview of regulatory requirements. Why and how to determine which filter, the media and pore ratings that are appropriate for various filtration applications. Apply knowledge of filter properties, including hydrophilic / hydrophobic, asymmetric / isomorphic and retention properties.

This Course presentation will examine the following key topics:
  • Definition of sterilizing grade & prefilters and pore size ratings.
  • Review of key terms and definitions of filtration functions.    
  • Filtration removal mechanism; sieving, adsorption, depth removal.
  • Mechanisms of entrapment / removal in liquids /gases.
  • Types of filter media; membrane verse depth filters.
  • Material of construction: how to choose the right media.
  • Integrity Testing, e.g., diffusive flow, bubble point, troubleshooting.
  • Validation requirements, e.g., bacterial challenge viability testing.
  • Extractables and Leachables Studies, when and why?
  • Overview of current industry standards and regulatory requirements.
About The Lecturer

Mr. Mark Trotter

A. Mark Trotter, MS, MBA,
with over twenty-five years experience in the pharmaceutical and life science industries, has a broad range of work experience, from pharmacologic chemistry research project leader to marketing management in the laboratory & process equipment industries. This extensive background in the biopharmaceutical sciences is coupled with an in-depth regulatory knowledge that supports his expertise in these areas of process validation and qualification.
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