PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications (single user digital version)

Oct 2015
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PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications.

Over the past decade, a large number of subcutaneously injected biotechnology drug products have been packaged in PFSs because of the benefits compared to vials or ampules. The benefits of PFSs include reduction of medical dosing errors, reduction in risk of microbial contamination by decreased manipulation prior to injection, and improved compliance due to ease of use. In addition to the patient benefits, PFSs often have lower overfill regulatory requirements than vials, thereby reducing product waste.

This report provides guidance on material selection and evaluation for suitability, syringe preparation and handling (including human factors), and drug product compatibility (physical and chemical) with the syringe materials and mode of delivery. Plastic syringes and ancillary devices, such as autoinjectors, are not within scope.

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Format: PDF (1 file 3.11 MB)

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Prefilled Syringe Development and Licensing
  4. PFS Human Factors Engineering
  5. Extractables and Leachables Evaluation
  6. Glass Barrel Requirements
  7. Needle Requirements
  8. Needle-Shield Requirements
  9. Cosmetic Imperfections
  10. Siliconization
  11. Plunger Stopper Suitability
  12. Container Closure Integrity Requirements
  13. Manufacturing Requirements
  14. Drug Product Compatibility
  15. Appendix I: Electronic Common Technical Document (ECTD) Application Submission Overview
  16. Appendix II: Module 3 For Electronic Common Technical Document (ECTD) Submission Overview
  17. Appendix III: Tests, Standards, and Guidance Documents for PFS Combination Products
  18. Appendix IV: Compound Classification with the Associated Threshold of Toxicological Concern (TTC)
  19. References

Figures and Tables Index