Microbial Monitoring of Pharmaceutical Grade Water Systems ... | 合法醫療器材資訊網
2018年10月11日—Thewidelyusedmicrobialcountofnotmorethan500CFU/mLisnotanEPAregulatoryrequirementbutusedtoevaluatepotablewater ...
Pharmaceutical grade water is critical material for equipment cleaning, as well as ingredient water in drug products, so it deserves our attention. Commonly expressed misconceptions held by pharmaceutical professionals including microbiologists, who should know better, about water monitoring include:
Potable water does not contain coliform bacteria. Incoming potable water from a water authority must be monitored at least weekly. The USP chapters <61> and <62> contain suitable tests for monitoring water. Purified water should routinely be screened for the absence of the USP specified bacteria E. coli, P. aeruginosa, and S. aureus, and the objectionable bacterium B. cepacia. AWWA/APHA Standard Methods must be validated for use in the pharmaceutical industry. The microbial counts recommended in USP <1231> for purified water and water for injection are scientifica...An Evaluation of Sampling and Laboratory Procedures for ... | 合法醫療器材資訊網
Dental Unit Water Quality | 合法醫療器材資訊網
Dental Unit Waterlines | 合法醫療器材資訊網
Heterotrophic plate count bacteria—what is their significance ... | 合法醫療器材資訊網
Heterotrophic Plate Counts and Drinking | 合法醫療器材資訊網
HPC | 合法醫療器材資訊網
Microbial Monitoring of Pharmaceutical Grade Water Systems ... | 合法醫療器材資訊網
Reducing bacterial counts in dental unit waterlines | 合法醫療器材資訊網
Water | Appendix | 合法醫療器材資訊網
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