Extractables and leachables from single-use disposables

BioProcess International

Volumn 7, Issue SUPPL.1, 2009, Pages 88-94

  Bestwick, Denise ^a   Colton, Raymond ^a,b  

^a Validation Resources LLC   (United States)

^b BPSA Extractables and Leachables Subcommittee ^*

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; DISPOSABLE EQUIPMENT; DRUG INDUSTRY; LEACHING; RISK ASSESSMENT; RISK FACTOR; SHORT SURVEY;

EID: 77953366107     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (13)

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3. Bio-Process Systems Alliance Guidelines and Standards Committee. Part One: Bio-Process Systems Alliance Component Quality Test Matrices. BioProcess Int. 5(4) 2007: 52-67.
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11. BPSA Extractables and Leachables Subcommittee. Recommendations for Extractables and Leachables Testing, Part Two: Executing a Program. BioProcess Int. 6(1) 2008: 44-52.
12. CDER/CBER. Draft Guidance Q8(R1) Pharmaceutical Development Revision 1. US Food and Drug Administration (Rockville, Maryland, USA). Updated 14 January 14, 2008 (www.fda.gov/cber/gdlns/ichq8pharmann.htm).
13. United States Pharmacopeial Convention. Chapter <467> Residual Solvents, USP 31 (Rockville, Maryland, USA, 2008).