Process Simulation for Aseptically Filled Products
A widely-used PDA Technical Report providing detailed industry guidance on designing, executing, and evaluating aseptic process simulations (media fills). TR 22 operationalises the media-fill expectations of EU GMP Annex 1 and FDA aseptic guidance.
Sterile manufacturers running aseptic process simulations. An industry best-practice reference — used to implement Annex 1 / FDA aseptic expectations, not a regulation.
- 01Design media fills that challenge the aseptic process realistically
- 02Define run size, incubation, and acceptance criteria
- 03Investigate any positive units thoroughly
PDA Technical Reports are periodically revised; align the version with the current Annex 1 (2022) expectations.
PDA TR No. 22: frequently asked questions
Quick answers to common questions about PDA TR No. 22.
What is PDA TR No. 22?
PDA TR No. 22 — Process Simulation for Aseptically Filled Products — is a guidance issued by the Parenteral Drug Association. A widely-used PDA Technical Report providing detailed industry guidance on designing, executing, and evaluating aseptic process simulations (media fills). TR 22 operationalises the media-fill expectations of EU GMP Annex 1 and FDA aseptic guidance.
Who does PDA TR No. 22 apply to?
Sterile manufacturers running aseptic process simulations. An industry best-practice reference — used to implement Annex 1 / FDA aseptic expectations, not a regulation.
What are the key requirements of PDA TR No. 22?
PDA TR No. 22 requires, among other things: Design media fills that challenge the aseptic process realistically; Define run size, incubation, and acceptance criteria; Investigate any positive units thoroughly.
When was PDA TR No. 22 last updated?
The current version of PDA TR No. 22 dates from January 2011. PDA Technical Reports are periodically revised; align the version with the current Annex 1 (2022) expectations.
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