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Manufacturing Sterile Products to Meet EU and FDA Guidelines

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In drug and device manufacturing, sterile means precisely what it says: The total absence of viable microorganisms. Obviously, not everyone is meeting this standard:

  • A meningitis outbreak kills 64 in 20 states. It is traced back to steroidal injections manufactured by a New England compounding center.
  • A Nevada-based compounder recalls all its sterile compounded products after the FDA issues warning for lack of sterility assurance and general quality control.
  • A China-based contract manufacturer and contract sterilizer, receives a warning letter for shortfalls in sterilization validation.

Poor microbial contamination control is now a top Form 483 observation. The focus to date has been on compounding pharmacies, but no FDA- or EU-regulated manufacturer is exempt from its country’s purity laws.

Now’s the time for a hard look at your manufacturing processes.

This timely new management report from FDAnews spells out how U.S. and EU manufacturers must handle sterile processing, focusing first on the basics:

  • Qualified and well-trained personnel
  • Suitable premises
  • Suitable production equipment
  • Validated methods for all critical manufacturing steps
  • Documentation of environmental conditions and in-process controls

You’ll examine in-depth the two methods to manufacture sterile medicinal products:

  • Terminal sterilization
  • Aseptic processing

Equally important — primary product packaging. This report offers clear guidance to the appropriate package sterilization method for every sterile product you offer.

Here’s just a sampling of specifics covered:

  • FDA and EU regulatory requirements sterile products must meet
  • How to set up workspaces and carry out manufacturing of terminally sterilized products
  • How to set up workspaces and manufacture sterile products under aseptic conditions
  • Cleanliness grades for clean rooms, personnel and materials, and how to achieve them
  • How to design and construct air locks to ensure the quality of clean room conditions
  • How to conduct risk-based validation for all sterile processes to meet GMP requirements
  • Advantages and disadvantages of common filling methods
  • How to prepare, implement, document and report a media fill
  • Measures to take when acceptance criteria are exceeded
  • About the freeze-drying process, including qualification and validation
  • About microbiological monitoring, including methods, equipment and contamination sources
  • And much more

The New England Compounding Center (NECC) has just agreed to a $100 million settlement in the meningitis case. That’s the last thing your company wants to face. Better order your copies of Manufacturing Sterile Products to Meet EU and FDA Guidelines … today.

Meet Your Guides
Ruven Brandes is a biological process engineer with extensive experience managing the engineering, qualification, cleaning validation, clean room ventilation, calibration, monitoring systems (production and storage), maintenance and servicing of sterile areas and equipment used in the production of medicinal products. He is a member of the International Association for Pharmaceutical Technology and the Association of German Engineers (VDI).

Dr. Margit Gieseler is CEO of Gilyos, which specializes in freeze-drying process design and optimization, physicochemical characterization of materials (freeze-dry microscopy), assessment of the morphology of freeze-dried products (specific surface area, scanning electron microscopy), technical consulting for freeze-drying equipment, operational qualification and performance testing. She has worked for Boehringer Ingelheim in pharmaceutical development. Her doctorate is in pharmaceutical technology.

Martin Mayer, an expert on HVAC systems and clean rooms in drug and device manufacture, has worked for Fresenius, Fresenius Kabi and Pharmaplan in numerous positions, including QA/QM, GMP compliance and consulting, SOP management, pharmaceutical-technical qualification and key accounting, product partnering, contract manufacturing and project management.

Dr. Hanfried Seyfarth has decades of expert experience as head of the departments of microbiology, quality control and process assurance at Boehringer Ingelheim.

Here’s a suggested list of potential readers:

  • Pharmaceutical plant managers
  • Device plant managers
  • Quality managers
  • Process assurance managers
  • GMP managers
  • CROs
  • Microbiologists

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