Regulatory expectations and consensus industry recommendations for extractables testing of single-use process equipment

BioPharm International

Volumn 23, Issue 11 SUPPL., 2010, Pages 6-10

  Martin, Jerold ^a,b  

^a Global Scientific Affairs   (United States)

^b Pall Life Science

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; BIOPROCESS; BIOREACTOR; BIOTECHNOLOGY; BULK DENSITY; CONSENSUS; DISPOSABLE EQUIPMENT; DRUG MANUFACTURE; DRUG PURIFICATION; DRUG SYNTHESIS; IRRADIATION; POLYMERIZATION; POSITIVE FEEDBACK; RISK ASSESSMENT;

EID: 78650460323     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (6)

1. BPSA Extractables and Leachables Subcommittee. Recommendations for extractables and leachables testing of single-use-part 1: Introduction, regulatory issues, and risk assessment. BioProcess Int. 2007 Dec;5(11):36-49.
2. BPSA Extractables and Leachables Subcommittee. Recommendations for extractables and leachables testing of single-use-Part 2: executing a program. BioProcess Int. 2008;6(1):44-53. BPSA. Available from: http://www.bpsalliance. org.
3. FDA 483 response review memo. Available from: http://www.fda.gov/ biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/ fractionatedplasmaproducts/ucm161014.htm.
4. FDA 483 response review memo.Available from: http://www.fda.gov/ biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/ fractionatedplasmaproducts/ucm161016.htm.
5. Sillivan, DM. Review of single use processes and materials: overview of types of data to be reviewed and specific areas of concern. IBC's 7th International Single Use Applications for Biopharmaceutical Manufacturing, La Jolla, CA: 2010 Jun 14.
6. BPSA Extractables Subcommittee. Recommendations for testing and evaluation of extractables from single-use process equipment. 2010: Washington, DC. Available from: http://www.bpsalliance.org.