Implementation of single-use technology in biopharmaceutical manufacturing: An approach to extractables and leachables studies, part three - Single-use systems

BioProcess International

Volumn 8, Issue 10, 2010, Pages 52-61

  Ding, Weibing ^a   Martin, Jerold ^a  

^a PALL CORPORATION   (United States)

Author keywords

Analytical methods; Disposables; Process validation

Indexed keywords

ANALYTIC METHOD; BIOPHYSICS; BIOTECHNOLOGY; DISPOSABLE EQUIPMENT; DRUG MANUFACTURE; INSTRUMENT STERILIZATION; IRRADIATION; PHARMACEUTICS; QUALITY CONTROL; QUANTITATIVE ANALYSIS; SHORT SURVEY; VALIDATION PROCESS;

EID: 78650363438     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (6)

1. Langer E. Advances in Large-Scale Pharmaceutical Manufacturing; 2nd Edition, BioPlan Associates Inc., Rockville USA. November 2007.
2. Caine B. BPSA Survey: The Impact of Single-Use Technologies. Bio-Process Systems Alliance, 2009; www.bpsalliance.org.
3. Colton R, et al. Extractables and Leachables Subcommittee of the Bio-Process Systems Alliance. Recommendations for Extractables and Leachables Testing. BioProcess Int. 6(3) 2008: S28-S39.
4. Martin J, et al. Recommendation for Testing and Evaluation of Extractables from Single-Use Process Equipment. Bio-Process Systems Alliance, April 2010; www.bpsalliance.org.
5. 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.
6. Ding W, Martin J. Implementing Single-Use Technology in Biopharmaceutical Manufacturing: An Approach to Extractables/Leachables Studies, Part Two - Tubing and Biocontainers. BioProcess Int. 7(5) 2009: 46-51.