Sterilizing Filter Process Validation - Essential Requirements

Maik Jornitz
Instructor Maik Jornitz
Product Id 601169
Duration 60 Minutes  
Version Recorded
Original Price $300
Special Offer Price $15
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Sterilizing Filter Process Validation - Essential Requirements

Overview:
Sterilizing filtration, utilizing membrane filter often of 0.2 micron rating, are critical in aseptic processing. As soon as heat sterilization cannot be used or bioburden requires to be reduced before heat sterilization, sterilizing grade filters are installed to remove the microbial burden.

Since an increasing fluid area cannot be heat sterilized, aseptic processing and the use of sterilizing grade filters are gaining importance. Filter manufacturers are able to supply filter qualification data, but these results are established under specific lab conditions and appropriate process validation requires to be performed by the end-user of the filter. Process validation takes the fluid to be filtered into consideration and the process parameters, used during filtration. Process validation is not only a regulatory requirement, but creates assurance that the filter used is of right choice and performs as expected. Regulatory guidance documents, like the FDA Aseptic Processing Guidance of 2004 and EC cGMP Annex 1 describe filter validation requirements, the most thorough though being PDA’s Technical Report #26, 2008. The webinar will describe filter qualification activities performed by the filter manufacturer and the resulting data. It will also touch on the guidances mentioned and the requirements set within. Followed by a detailed, step by step description of process validation needs and why these steps are of importance.

Why should you attend:
  • Participants will learn what are essential requirements of sterilizing filter process validation.
  • Participants will learn the details of individual process validation activities
  • Participants will learn how to differentiate between the absolute essential and useful process validation steps.
  • Participants will also the difference between qualification and process validation.
  • Multiple guidance documents will be discussed in regard to sterilizing grade filtration
  • In essence You will learn how important process validation of sterilizing filters is and what steps are required to perform such validation.

Areas Covered in the Session:
  • Introduction
  • Filter Qualification
  • Guidances
  • Process Validation:
    • Viability test
    • Bacteria Challenge test
    • Chemical compatibility
    • Adsorption analysis
    • Extractables analysis
    • Particulates
    • Product-wet integrity testing
    • Other evaluations
  • Conclusion
  • Questions & Answers

Who Will Benefit:
  • Validation management
  • Quality Unit Vice Presidents, Directors and Managers
  • Vice presidents, Directors and Managers of pharmaceutical operations
  • Process development Management and Technicians
  • Regulatory and Compliance Management
  • Consultants
Speaker Profile
Maik Jornitz is Chief Operating Officer at G-CON Manufacturing LLC, College Station, TX. ?With over 25 years of experience in separation and single-use technologies, the related regulations and validation requirements, Jornitz supports the biopharmaceutical industry on a world-wide basis. As a former member of the PDA Board of Directors and Science Advisory Board (SAB), Jornitz has been part of multiple PDA task forces, for example the Technical Report # 26, #40, #41, #45, mycoplasma task forces, and program co-chair for the 2008 and 2013 Annual Meeting. He is also member of the ISPE, ASTM, DIA and is faculty member of PDA TRI. Jornitz authored and co-authored over 100 scientific papers. He is co-editor and -author of 9 books for example Filtration and Purification in the Biopharmaceutical Industry, Sterile Filtration – A Practical Approach, Pharmaceutical Filtration and received 5 distinguished author awards, a PDA special service and Michael S. Korczynski award. He has contributed in total 14 chapters to various technical books, including the Encyclopedia of Pharmaceutical Technology. He holds over 30 patents related to biopharmaceutical process equipment (single-use technology) and integrity testing. ?He formerly worked for Sartorius Stedim in various positions for over 25 years. In addition, he is the founder of BioProcess Resources LLC, a consulting group specialized in sterilizing filtration, integrity testing and single-use technology and Science Advisory Board member of Artemes Technologies. ?Mr. Jornitz received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.?

Specialties: Technical expert in sterilizing grade filtration and single-use technologies within the biopharmaceutical industry, including regulatory requirements, validation, integrity testing, trouble shooting, systems design and optimization. Commonly advises, consults, trains, audits end-users and regulators. Specialty, optimizing processes by analyzing process steps technically and economically, which resulted to either cost savings or additional revenue potentials.
Background : 
The rising uses of aseptic processing respectively sterilizing grade filtration, due to the impossibility of heat sterilization of biologic drug products, also raise the regulatory scrutiny on the validation of sterilization by filtration. There are essential activities, which need to be taken, and which are expected to validate filters. 

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