Visible-residue limit for cleaning validation and its potential application in a pharmaceutical research facility

Pharmaceutical Technology

Volumn 28, Issue 10, 2004, Pages 58-72

  Forsyth, Richard J ^a   Van Nostrand, Vincent ^a   Martin, Gregory P ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL EQUIPMENT; RESEARCH AND DEVELOPMENT MANAGEMENT;

EQUIPMENT CLEANLINESS; PHARMACEUTICAL RESEARCH;

DRUG PRODUCTS;

ALENDRONIC ACID; APREPITANT; ASCORBIC ACID; CALCIUM PHOSPHATE; CELLULOSE; CROSCARMELLOSE SODIUM; CYCLOBENZAPRINE; DODECYL SULFATE SODIUM; ENALAPRIL MALEATE; FAMOTIDINE; FERRIC OXIDE; FINASTERIDE; GALLIC ACID PROPYL ESTER; HYDROXYPROPYLCELLULOSE; INDINAVIR; LACTOSE; LOSARTAN POTASSIUM; MAGNESIUM STEARATE; MANNITOL; MICROCRYSTALLINE CELLULOSE; MONTELUKAST; POLOXAMER; RIZATRIPTAN; ROFECOXIB; SILICON DIOXIDE; SIMVASTATIN; STARCH GLYCOLATE SODIUM; SUCROSE; TITANIUM DIOXIDE; UNINDEXED DRUG;

CLEANING; DRUG FORMULATION; EVALUATION; LIGHT INTENSITY; PHARMACEUTICS; RESEARCH; REVIEW; VALIDATION PROCESS;

EID: 5644281784     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (8)

1. Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington, DC, 1 April 1973), Part 211.67.b.6.
2. R.J. Forsyth and D. Haynes, "Cleaning Validation in a Pharmaceutical Research Facility," Pharm. Technol. 22 (9), 104-112 (1998).
3. D.W. Mendenhall, "Cleaning Validation," Drug Dev. Ind. Pharm. 15 (13), 2105-2114 (1989).
4. Food and Drug Administration, "Guide to Inspection of Validation of Cleaning Processes" (Division of Field Investigations, Office of Regional Operations, Office of Regulatory Affairs, July 1993).
5. D. A. LeBlanc, "'Visually Clean' as a Sole Acceptance Criteria for Cleaning Validation Protocols," PDA J. Pharm. Sci. Technol. 56 (1), 31-36 (2002).
6. G. L. Fourman and M. V. Mullen, "Determining Cleaning Validation Acceptance Limits for Pharmaceutical Manufacturing Operations," Pharm. Technol. 17 (4), 54-60 (1993).
7. K.M. Jenkins and A. J. Vanderwielen, "Cleaning Validation: An Overall Perspective," Pharm. Technol. 18 (4), 60-73 (1994).
8. D.A. LeBlanc, D.D. Danforth, and J.M. Smith, "Cleaning Technology for Pharmaceutical Manufacturing," Pharm. Technol. 17 (10), 118-124 (1993).