PDA Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (single user digital version)

Feb 2017
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PDA's newly released Technical Report No. 77 (TR 77), The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology provides recommendations specific to the operation of blow-fill-seal (BFS) technology for the manufacture of sterile pharmaceuticals (e.g., ophthalmic, parenteral, and inhalation). The intent of this document is to provide supplemental information to assist the user with interpretation of international standards and regulatory guidance from the perspective of BFS operations. Consideration is given to specific aspects of BFS operations not covered in published information.

This Technical Report addresses considerations for BFS technology related to the installation and operation of machinery and evaluation of related materials and final product containers. Support areas such as laboratory, solution compounding, gowning airlocks, etc. are not considered specific to blow-fill-seal and are not included within the scope of this document. This technical report is intended as a guide for the industry and is not meant to supplant or duplicate any existing regulatory guidance.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. BFS Equipment
  4. Benefits & Special Considerations of BFS Technology
  5. Design
  6. Operational and Qualification Considerations
  7. Quality Risk Assessment
  8. References
  9. Appendix I: Example of a Quality Risk Assessment
  10. Appendix II: Environmental Particle Monitoring Levels

Figures and Tables Index