PDA Research: 2021 PDA Aseptic Processing Simulation Survey (Single user digital version)

Dec 2022
PDA Item Number

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

PDF Single User
Member Price
Nonmember Price
Government Price
The 2021 PDA Aseptic Process Simulation for Sterile Bulk Pharmaceuticals Survey was designed to provide insight on current industry practices of the aseptic process simulation (APS) used in the production of aseptically produced sterile bulk pharmaceuticals. There were 42 respondents with the survey covering topics related to APS Concepts and Principles, APS Test Methods and Materials, Documentation, Environmental Monitoring, Interventions, Operator Qualification, and Acceptance Criteria.

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents
  1. Introduction
  2. Introduction
  3. Demographics
  4. Technilogies
  5. General Questions
  6. APS Concepts and Principles
  7. APS Test Methods and Materials
  8. Documentation and Environmental Monitoring
  9. Interventions and Operator Qualification
  10. Acceptance Criteria Application
  11.  Environmental Monitoring Prerequisites
  12. References

Figures and Tables Index

About the Authors