Airborne contamination during Blow-Fill-Seal pharmaceutical production

PDA Journal of Pharmaceutical Science and Technology

Volumn 52, Issue 3, 1998, Pages 89-99

  Whyte, W ^a   Matheis, W ^b   Dean Netcher, Mark ^c   Edwards, Alan ^d  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b Holopack GmbH   (Germany)

^c Ciba Vision   (United Kingdom)

^d BOEHRINGER INGELHEIM LTD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AIRBORNE PARTICLE; ARTICLE; ASEPSIS; BACTERIUM CONTAMINATION; DRUG CONTAMINATION; DRUG PACKAGING; DRUG STERILITY; LAMINAR AIRFLOW; VENTILATOR;

AIR MICROBIOLOGY; COLONY COUNT, MICROBIAL; DRUG CONTAMINATION; DRUG PACKAGING; GASES;

EID: 0031815013     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

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2. W. Whyte, "In support of settle plates," J. Pharm. Sci. Technol., 50, 201 (1996).
3. W. Whyte and N. D. S. Bell, "The prediction of airborne contamination of aseptically filled containers: A case study," (in press).
4. D. J. Jones, P. Topping, and J. Sharp, "Environmental microbial challenges to an aseptic blow-fill-seal process: A practical study," J. Pharm. Sci. Technol. 49, 226 (1995).
5. P. Johnstone, "Environmental monitoring and media fills in a blow-fill-seal facility," Eur. J. Parent. Sci., 2(3), 89 (1997).
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7. A. Bradley, S. P. Probert, C. S. Sinclair, and A. Tallentire, "Airborne microbial challenges of blow/fill/seal equipment: A case study," J. Parent. Sci. Technol., 45, 187 (1991).
8. C. S. Sinclair and A. Tallentire, "Predictive sterility assurance for aseptic processing," in R. F. Morrissey, Ed. Sterilization of Medical Products, VI, Polyscience Publications, Montreal. 1993, pp97-114.
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10. W. Whyte, "Settling and impaction of particles into containers in manufacturing pharmacies," J. Parent. Sci. Technol. 36, 255 (1981).
11. W. Whyte, L. Niven, and N. D. S. Bell, "Microbial growth in small-volume pharmaceuticals," J. Parent. Sci. Technol. 43, 208 (1989).