Live eLearning - PDA 539.1 Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology

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This training course is designed to provide and evaluate recommendations specific to the operation of Blow-Fill-Seal (BFS) technology for the manufacture of sterile pharmaceuticals, e.g., injectable, ophthalmic, parenteral, and inhalation drugs and medical devices. Supplemental information to assist users with interpretation of international standards and regulatory guidance regarding BFS operations will also be provided.

Basic knowledge of aseptic fill/finish packaging, cGMP and regulatory requirements is desired.

For more options and/or related training courses, please visit the page(s) below.

PDA Parenteral Packaging Training Courses

  1. Describe the recommended requirements necessary to utilize blow-fill-seal (BFS) fill/finish technology
  2. Assess if BFS technology can be applied to new or existing pharma products
  3. Describe the basic principles of BFS: cleanroom facility design, environmental monitoring, and aseptic processing
  4. Explain the process of evaluating product contact materials, extractable profiles and leachable risk
  5. Evaluate the aseptic risk of BFS in comparison to other advanced aseptic fill/finish operations: isolators and closed RABS systems

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Standard Pricing

Standard Member Price

$500

GovernmentMember Only

$500

Health AuthorityMember Only

$500

AcademicMember Only

$500

Non-Member

$500

See Qualifying Criteria for Member Types.

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