PDA Technical Report No. 62 (TR 62) Recommended Practices for Manual Aseptic Processes (single user digital version)

Jun 2013
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The purpose of this technical report is to outline methods and approaches for control and evaluation of aseptic processing operations for drug products/medicinal products which use all or partially manual procedures. This technical report has value for hospital and formulation pharmacies where manual aseptic processing may occur. The guidance provided in this report may be applicable to operations including: vaccine preparation, cell culture, gene therapy, Investigational New Drug/IMP manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing.

This report is not intended to address the brief, relatively infrequent, human interventions into an otherwise automated filling process. Examples include reach-ins to remove a toppled vial from the filling line or to obtain a container for a fill-weight check, aseptic connections made during set-up, corrective activities during line stoppages, and so on.

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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Buildings and Facilities
  4. Operational Personnel Training and Qualification
  5. Equipment, Components and Container/Closure
  6. Process Time Limitations
  7. Design of Manual Aseptic Processes
  8. Evaluation of Manual Aseptic Processing-Process Simulation
  9. Conclusion
  10. References
  11. Additional Reading

Table Index