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

Published
Dec 2022
ISBN
9781945584367
Pages
63
PDA Item Number
43563

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Format
PDF Single User
Member Price
$180.00
Nonmember Price
$325.00
Government Price
$180.00
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