A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas.
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| Title: | A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas. |
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| Authors: | Nakka G; Catalent Pharma Solutions, 191 Everett Ave, Chelsea, 01864, United States of America., Gupta S; Independent Researcher, University of Louisiana at Lafayette., Katti KR; President/Principal Consultant, Sterilexcellence Ownership, 5002 Cassandra Court, Ringwood, Illinois, 60072, United States of America. |
| Source: | PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2026 Jun 18. Date of Electronic Publication: 2026 Jun 18. |
| Publication Type: | Journal Article |
| Journal Info: | Publisher: Pda (Parenteral Drug Association) Country of Publication: United States NLM ID: 9439538 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1948-2124 (Electronic) Linking ISSN: 10797440 NLM ISO Abbreviation: PDA J Pharm Sci Technol Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| ISSN: | 1948-2124 |
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| DOI: | 10.5731/pdajpst.2026-000013.1 |
