Biomedical Engineering Reference
In-Depth Information
24. Whyte W. A cleanroom contamination control system. Eur J Parenter Sci 2002;7(2):
55-61.
25. Whyte W, Eaton T. Microbial risk assessment in pharmaceutical cleanrooms. Eur J
Parent Pharma Sci 2004;9(1):16-23.
26. Whyte W, Eaton T. Microbiological contamination models for use in risk assessment
during pharmaceutical production. Eur J Parenter Pharma Sci 2004;9(1):11-15.
27. Tidswell E, McGarvey B. Quantitative risk modeling in aseptic manufacture. PDA J
Pharm Sci Tech 2006;60(5):267-283.
28. Berrios G. Sterility Assurance Risk Management. Arlington (VA): Presentation at IVT
Aseptic Processing Conference; 2009.
29. Agalloco J, Akers J. Risk analysis for aseptic processing: the akers-agalloco method.
Pharma Technol 2005;29(11):74-88.
30. Agalloco J, Akers J. Simplified risk analysis for aseptic processing: the akers-agalloco
method. Pharma Technol 2006;30(7):60-76.
31. PDA Technical Report No. 44, Quality Risk Management for Aseptic Processes
2008;62(S-1).
32. Charlton W. Applying quality by design to sterile manufacturing processes. Pharma
Technol 2009;33(5):S28-S32, S42.
33. Katayama H, Toda A, Tokunaga Y, Katoh S. Proposal for a new categorization of
aseptic processing facilities based on risk assessment scores. PDA J Pharm Sci Tech
2008;62(4):235-243.
34. FDA, Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987.
35. Agalloco J, Akers J. The truth about interventions in aseptic processing. Pharma
Technol 2007;31(5):S8-S11.
36. Agalloco J, Akers J. Validation of aseptic processing. In: Agalloco J, Carleton FJ,
editors. Validation of Pharmaceutical Processes. 3rd ed. New York, USA: Informa;
2007.
37. FDA, Draft Guideline: Guidance for Industry-Process Validation: General Principles
and Practices, 2008 Nov.
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