Academic Journal
PAT Implementation-Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products.
| Τίτλος: | PAT Implementation-Managing the Transition from Traditional Environmental Monitoring to In-Process Control of Aseptically Filled Products. |
|---|---|
| Συγγραφείς: | Cundell T; Microbiological Consulting, LLC, Rye, NY tonycundell@gmail.com. |
| Πηγή: | PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2026 Oct 09; Vol. 80 (5), pp. 580-586. Date of Electronic Publication: 2026 Oct 09. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Bethesda Md : Pda (Parenteral Drug Association) |
| Ιατρικοί όροι (MeSH): | Environmental Monitoring*/methods , Environmental Monitoring*/standards , Technology, Pharmaceutical*/methods , Technology, Pharmaceutical*/standards |
| Περίληψη: | Managing the transition to the new paradigm of in-process control using continuous biofluorescent particle counters from the traditional growth-based air monitoring is a difficult challenge requiring a comprehensive regulatory strategy. This is best approached within the confines of the concept of process analytical technology. A five-stage approach to the evaluation, validation, test runs and data analysis, regulatory approval, and implementation is recommended. Critical to the implementation is the application of the safe harbor concept to avoid noncompliance issues. (© PDA, Inc. 2026.) |
| Contributed Indexing: | Keywords: Alert levels and action limits; Biofluorescent particle counters; In-process monitoring; Process analytical technology; Regulatory strategy; Safe harbor concept |
| Entry Date(s): | Date Created: 20251124 Date Completed: 20261009 Latest Revision: 20261009 |
| Update Code: | 20261010 |
| DOI: | 10.5731/pdajpst.2025-000044.1 |
| PMID: | 41285552 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1948-2124 |
|---|---|
| DOI: | 10.5731/pdajpst.2025-000044.1 |