PDA Research: 2021 PDA Aseptic Processing Simulation Survey (Single user digital version)
- Published
- Dec 2022
- ISBN
- 9781945584367
- Pages
- 63
- PDA Item Number
- 43563
Premium Members: to claim your annual free technical document download, email membership@pda.org and indicate the document you wish to claim.
- Format
- PDF Single User
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
Please sign in or become a member to purchase items from the PDA bookstore.
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- Introduction
- Introduction
- Demographics
- Technilogies
- General Questions
- APS Concepts and Principles
- APS Test Methods and Materials
- Documentation and Environmental Monitoring
- Interventions and Operator Qualification
- Acceptance Criteria Application
- Environmental Monitoring Prerequisites
- References
Figures and Tables Index
About the Authors