Implementation of single-use technology in biopharmaceutical manufacturing: An approach to extractables/leachables studies, part two - Tubing and biocontainers

BioProcess International

Volumn 7, Issue 5, 2009, Pages 46-51

  Ding, Weibing ^a   Martin, Jerold ^a  

^a PALL CORPORATION   (United States)

Author keywords

Analytical methods; Disposables; Process validation

Indexed keywords

ANALYTIC METHOD; BIOTECHNOLOGY; CONTAINER; DRUG INDUSTRY; FILTRATION; RISK ASSESSMENT; SHORT SURVEY;

EID: 77953442510     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (6)

1. Ding W, Martin J. Implementing Single-Use Technology in Biopharmaceutical Manufacturing: An Approach to Extractables/Leachables Studies, Part One - Connectors and Filters. BioProcess Int. 6(9) 2008: 34-42.
2. Colton R, et al. Extractables and Leachables Subcommittee of the Bio-Process Systems Alliance. Recommendations for Extractables and Leachables Testing, Part 1: Introduction, Regulatory Issues, and Risk Assessment. BioProcess Int. 5(11) 2007: 36-44.
3. Colton R, et al. Extractables and Leachables Subcommittee of the Bio-Process Systems Alliance. Recommendations for Extractables and Leachables Testing, Part 2: Executing a Program. BioProcess Int. 6(1) 2008: 44-52.
4. Goldstein A, et al. Disposable Systems in Biopharm Production: Design, Compliance, and Validation Methods - A Case Study (Part 2). Amer. Pharm. Rev. 9(1) 2006: 10-25.
5. Goldstein A, et al. Methods and Considerations for Disposables Implementation: Design, Compliance, and Validation. BioProcess Int. 3(9) 2005: S20-S27.
6. USTR2475. Validation Guide: Allegro™ Biocontainers. Pall Life Sciences: East Hills, NY.