Filters and Filtration in Aseptic Processes

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

תאריך: 26, 27 נובמבר 2018
מיקום הקורס: כפר המכביה, רמת גן
מידע כללי
משך הפעילות: 2 ימי לימודים מלאים
שעות:  09:00-17:00
עלות: 4,700 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 18471
שפת הקורס: אנגלית
על הקורס

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.

קהל היעד

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.

התועלת שתופק

  • 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.
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס

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.
אודות המרצה

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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