Environmental Monitoring: A Correlation Study between Viable and Nonviable Particles in Clean Rooms

PDA Journal of Pharmaceutical Science and Technology

Volumn 58, Issue 1, 2004, Pages 45-53

  De Abreu, Catherine Simões ^a   De Jesus Andreoli Pinto, Terezinha ^a   De Oliveira, Débora Cristina ^a  

^a UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

Clean rooms; Environmental monitoring; Microbial contamination; Nonviable particles; Viable particles

Indexed keywords

ARTICLE; DRUG MANUFACTURE; ENVIRONMENTAL MONITORING; EQUIPMENT; LAMINAR FLOW; MICROBIAL CONTAMINATION; PARTICLE SIZE; SAMPLING; WORK ENVIRONMENT;

AIR POLLUTANTS; ENVIRONMENTAL MICROBIOLOGY; ENVIRONMENTAL MONITORING;

EID: 1342330137     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. Food and Drug Administration. Guideline on sterile drug products produced by aseptic processing; Rockville, MD, 1987; p. 43.
2. Hertroys, R.; Van Vught, P. A. M.; Van de Donk, H. J. M. Moving towards a (microbiological) environmental monitoring program that can be used to release aseptically produced pharmaceuticals: a hypotheses, a practical program, and some results. J. Parenter. Sci. Technol. 1997, 51(1), 52-9.
3. Akers, J. E. Environmental monitoring and control proposed standards, current practices, and future directions. J. Parenter. Sci. Technol. 1997, 51(1), 36-47.
4. Schicht, H. H. International clean room standards and their impact on the pharmaceutical industry. In: International Symposium of Contamination Control Proceedings; Institute of Environmental Sciences and Technology: Phoenix, AZ, 1998; p110-44.
5. European Guide to Good Manufacturing Practice. Working party on control of medicines and inspections. Industrial affairs III: Consumer goods industries. Pharmaceutical products. Brussels; September, 1996, pp 2-4.
6. United States Pharmacopeia, 25th ed. United States Pharmacopeial Convention: Rockville, MD, 2002; p 1116.
7. Agalloco, J. Qualification and validation of environmental systems. J. Parenter Sci. Technol. 1996, 50(5), 280-9.
8. Institute of Environmental Sciences. Federal standard 209 E: airborne particulate cleanliness in clean rooms and clean zones, IES: Mount Prospect, IL, 1992; p 48.
9. Ljungqvist, B.; Reinmuller, B. Interaction between air movements and the dispersion of contaminants: clean zones with unidirectional air flow. J. Parenter. Sci. Technol. 1993, 47, 60-9.
10. Food and Drug Administration, Center for Drug Evaluation and Research. Guideline on Sterile Drug Products Produced by Aseptic Processing: Topic 3: Environmental Monitoring. In: Guidance for Industry. United States Pharmacopeial Convention: Rockville, MD, 2002; p 535-99. (Also: PDA/USP Joint Conference on Sterile Products Manufacturing, May 2002).