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Title:
Validated cleaning technologies for pharmaceutical manufacturing
Author:
LeBlanc, Destin A.
ISBN:
9781420025880
Publication Information:
Denver, Colo. : Interpharm Press ; Boca Raton, Fla. : CRC Press, c2000.
Physical Description:
xv, 288 p. : ill. ; 24 cm
Contents:
1. Cleaning objectives -- 2. Cleaning and cleaning agents -- 3. Cleaning methods -- 4. Process parameters in cleaning : part I -- 5. Process parameters in cleaning : part II -- 6. Cleaning cycle development -- 7. Grouping strategies -- 8. Setting acceptance criteria -- 9. Analytical methods for cleaning validation -- 10. Sampling methods for cleaning validation -- 11. Microbial issues in cleaning validation -- 12. Change control and revalidation -- 13. Special topics in cleaning validation -- 14. FDA expectations.
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