Consideration of media fill tests for evaluation and control of aseptic processes: A statistical approach to quality criteria

PDA Journal of Pharmaceutical Science and Technology

Volumn 56, Issue 5, 2002, Pages 235-241

  Kawamura, Kunio ^a   Abe, Hiroshi ^a  

^a OTSUKA PHARMACEUTICAL CO LTD   (Japan)

Author keywords

Acceptance criteria; Acceptance probability; Confidence level; Media fill test; Operating characteristics

Indexed keywords

ARTICLE; ASEPSIS; CONFIDENCE INTERVAL; DRUG MANUFACTURE; EVALUATION; MEDIA FILL TEST; MICROBIAL CONTAMINATION; PROCESSING; QUALITY CONTROL; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; TECHNIQUE; VALIDATION PROCESS;

ASEPSIS; CONFIDENCE INTERVALS; EQUIPMENT CONTAMINATION; HUMANS;

EID: 0036748952     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (10)

1. USP, United States Pharmacopoeia, 24, 〈1116〉 Microbiological Evaluation of Clean Rooms and Other Controlled Environments, pp.2104. Rockville, MD, USA (2000).
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3. JP, Japanese Pharmacopoeia, XIV, Media Fill Test, The Society of Japanese Pharmacopoeia, 212-15, Shibuya, Sibuya-ku, Tokyo (2001).
4. ISO 13408-1, "Aseptic Processing of Health Care Products, Part 1: General Requirements," International Standards Organization, pp.16-21 (1998).
5. Kawamura, K., J. Parent. Sci. Tech., 48 (5), 220 (1994).
6. Bernuzzi, M., N. A. Halls, and P. Raggi, "Application of Statistical Models to Action Limits for Media Fill Trials," European Journal of Parenteral Sciences, 2 (1), 3-11 (1997).
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8. Neyman, J. and E. S. Peason, Trans. Roy. Soc. London, A, 31, pp.289-337 (1933).
9. FDA CDER, "Sterile Drug Products by Aseptic Processing," Draft Revisions (1998).
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