Statistical analysis of environmental monitoring data: Does a worst case time for monitoring clean rooms exist?

PDA Journal of Pharmaceutical Science and Technology

Volumn 52, Issue 6, 1998, Pages 326-330

  Cundell, Anthony M ^a,c   Bean, Robert ^b   Massimore, Lori ^b   Maier, Christoph ^a  

^a PFIZER INC   (United States)

^b Wyeth Lederle Vaccines and Pediat   (United States)

^c NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BACTERIUM CONTAMINATION; CONTROLLED STUDY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG PACKAGING; ENVIRONMENTAL MANAGEMENT; ENVIRONMENTAL MONITORING; ENVIRONMENTAL SANITATION; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; INDUSTRIAL HYGIENE; SAMPLING;

DRUG INDUSTRY; ENVIRONMENTAL MICROBIOLOGY; ENVIRONMENTAL MONITORING; STATISTICS;

EID: 0032469092     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (2)

1. USP Draft Chapter 〈1116〉, "Microbiological Evaluation of Clean Rooms and other Controlled Environments" in USP Open Conference Microbiological Compendial Issues.
2. Pharmacopeial Forum Vol. 23, No. 1, In-Process Revision USP Informational Chapter 〈1116〉 Microbiological Evaluation of Clean Rooms and other Controlled Environments Jan-Feb. 1997