Method development of swab sampling for cleaning validation of a residual active pharmaceutical ingredient

Pharmaceutical Technology

Volumn 29, Issue 1, 2005, Pages 84-94

  Yang, Pei ^a   Burson, Kim ^a   Feder, Debra ^a   Macdonald, Fraser ^a  

^a MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLEANING; EXTRACTION; SAMPLING;

CLEANING VALIDATION; EXTRACTION METHOD; PHARMACEUTICAL INGREDIENT; SWAB SAMPLING;

DRUG PRODUCTS;

SOLVENT;

ACCURACY; ANALYTIC METHOD; CLEANING; CONTAMINATION; EXTRACTION; FILTER; METHODOLOGY; REVIEW; SAMPLING; SWAB SAMPLING; TECHNIQUE; VALIDATION PROCESS;

EID: 18844417682     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (14)

1. Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington DC, April 1973), Part 211.67.
2. Pharmaceutical Process Validation, I.R. Berry and R.A. Nash, Eds. (Marcel Dekker, New York, NY, 2d ed.)
3. Food and Drug Administration, "Guide to Inspections of Validation of Cleaning Processes," (FDA, Rockville, MD, July 1993).
4. G. M. Chudzik, "General Guide to Recovery Studies Using Swab Sampling Methods for Cleaning Validation," J. Validation Technol. 5 (1), 77-81 (1998).
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10. D. A. LeBlanc, "Establishing Scientifically Justified Acceptance Criteria for Cleaning Validation of Finished Drug Products," Pharm. Technol. 22 (10), 136-148 (1998).
11. Revision 7 of the preclinical insert for Integrilin injection, Millennium Pharmaceutical, Inc. (Cambridge, MA, 2002).
12. Operator's Manual: Baker SterilGARD Biological Safety Cabinet, The Baker Company (Sanford, Maine, 1998).
13. W.E. Hall, "Your Cleaning Program: Is It Ready for the Pre-Approval Inspection," J. Validation Technol. 4 (4), 302-308 (1998).
14. Fax memo from the Baker Ccmpany on 10 December 2002.