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 |
| FullText | Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 42320909 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Nakka+G%22">Nakka G</searchLink>; Catalent Pharma Solutions, 191 Everett Ave, Chelsea, 01864, United States of America.<br /><searchLink fieldCode="AU" term="%22Gupta+S%22">Gupta S</searchLink>; Independent Researcher, University of Louisiana at Lafayette.<br /><searchLink fieldCode="AU" term="%22Katti+KR%22">Katti KR</searchLink>; President/Principal Consultant, Sterilexcellence Ownership, 5002 Cassandra Court, Ringwood, Illinois, 60072, United States of America. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%229439538%22">PDA journal of pharmaceutical science and technology</searchLink> [PDA J Pharm Sci Technol] 2026 Jun 18. <i>Date of Electronic Publication: </i>2026 Jun 18. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Pda+%28Parenteral+Drug+Association%29%22">Pda (Parenteral Drug Association) </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>9439538 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1948-2124 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2210797440%22">10797440 </searchLink><i>NLM ISO Abbreviation: </i>PDA J Pharm Sci Technol <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42320909 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.5731/pdajpst.2026-000013.1 Languages: – Code: eng Text: English Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Nakka G – PersonEntity: Name: NameFull: Gupta S – PersonEntity: Name: NameFull: Katti KR IsPartOfRelationships: – BibEntity: Dates: – D: 18 M: 06 Text: 2026 Jun 18 Type: published Y: 2026 Identifiers: – Type: issn-electronic Value: 1948-2124 Titles: – TitleFull: PDA journal of pharmaceutical science and technology Type: main |
| ResultId | 1 |
