Implementation of disposables: Validation and other considerations

American Pharmaceutical Review

Volumn 9, Issue 5, 2006, Pages

  Samavedam, Ravi ^a   Goldstein, Adam ^a   Schieche, David ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ETHYLENE VINYL ACETATE COPOLYMER; ETHYLENE VINYL ALCOHOL COPOLYMER; POLYETHYLENE;

BIOPROCESS; BIOTECHNOLOGY; CLINICAL PRACTICE; COST BENEFIT ANALYSIS; DISPOSABLE EQUIPMENT; DRUG MANUFACTURE; DRUG PACKAGING; ECONOMIC ASPECT; ENVIRONMENTAL TEMPERATURE; HEALTH SERVICE; INSTRUMENT STERILIZATION; MEDICAL DOCUMENTATION; MICROBIAL PEST CONTROL; PHENOTYPE; REVIEW; VALIDATION STUDY;

EID: 37449019471     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (4)

1. Goldstein, Adam; Schieche, David; Harter, Jim; Samavedam, Ravi; Wilkinson, Lindsay; Manocchi, Amy. "Methods and Considerations for Disposables Implementation: Design, Compliance and Validation" BioProcess International Supplement. October 2005. Pgs 20-35.
2. Brecht, Rene et al. "Boosting Mammalian Cell-line Manufacturing Pilot Plant - A Case Report" BioPharm International. July 2005 Pgs 22-30
3. Bennan, John; Bing, Frank; Boone, Heather; Fernandez, Jim; Miller, Don; Seeley, Bob; van Deinse, Harold. "Evaluation of Extractables from Product-Contact Surfaces" BioPharm International. Volume 15, 12. Pgs 22-34.
4. Fisher, Michael. "A Stirred-Tank Bioreactor - Delivered in Eight Weeks and One Hour" BioProcess International Supplement. June 2006. Pgs 28-30.