USP general chapter 1072-disinfectants and antiseptics

beiwei5du

选自USP general chapter 1072-disinfectants and antiseptics
按照国外FDA的说法，针对于critical process steps（比如无菌操作区域的消毒，我在多个国外PPT课件中均是涉及到相应的aseptical operation areas）在美国GMP法规层面是要求进行相关的消毒效果验证的，那么针对于一般的非critical 区域（比如D级区，而且是非无菌的原料药或者固体口服制剂）进行消毒效果验证（比如做微生物挑战试验），是否有有必要呢？？？比如针对于生产D级区域的臭氧消毒，是否仅仅做在生产现场的cleanroom做相应的浓度监测，而在实验室做预定时间（比如30minuts）,浓度与消毒效果联系（比如针对于bacterial spore2个log reduction以及针对于vegetative bacteria 3个 log reduction）即可！
求指导？？？@江苏新征鸿净化 @youwenmicro

DISINFECTANT CHALLENGE TESTING

Under FIFRA, the EPA requires companies that register public health antimicrobial pesticide products including disinfectants, sanitization agents, sporicidal agents, and sterilants to ensure the safety and effectiveness of their products before they are sold or distributed. Companies registering these products must address the chemical composition of their product, include toxicology data to document that their product is safe if used as directed on the label, include efficacy data to document their claims of effectiveness against specific organisms and to support the directions for use provided in the labeling, and provide labeling that reflects the required elements for safe and effective use. While these directions provide valuable information, they may not be helpful in terms of the products' use as disinfectants in a manufacturing environment.

In the United States, the official disinfectant testing methods are published by AOAC International3 and include the Phenol-Coefficient Test, Use-Dilution Method Test, Hard Surface Carrier Method, and Sporicidal Carrier Test. A scientific study submitted for EPA review in support of disinfectant registration must be conducted at a laboratory facility that follows the Good Laboratory Practices (GLP) regulations (21 CFR 58).
To demonstrate the efficacy of a disinfectant within a pharmaceutical manufacturing environment, it may be deemed necessary to conduct the following tests:
(1) use-dilution tests (screening disinfectants for their efficacy at various concentrations and contact times against a wide range of standard test organisms and environmental isolates);
(2) surface challenge tests (using standard test microorganisms and microorganisms that are typical environmental isolates, applying disinfectants to surfaces at the selected use concentration with a specified contact time, and determining the log reduction of the challenge microorganisms); and
(3) a statistical comparison of the frequency of isolation and numbers of microorganisms isolated prior to and after the implementation of a new disinfectant.
This is considered necessary because critical process steps like disinfection of aseptic processing areas, as required by GMP regulations, need to be validated, and the EPA registration requirements do not address how disinfectants are used in the pharmaceutical, biotechnological, and medical device industries. For the surface challenge tests, the test organisms are enumerated using swabs, surface rinse, or contact plate methods. Neutralizers that inactivate the disinfectants should be included in either the diluent or microbiological media used for microbial enumeration or both. Information on disinfectant neutralization may be found inValidation of Microbial Recovery from Pharmacopeial Articles 1227.

beiwei5du

Selected EPA-registered Disinfectants
https://www.epa.gov/pesticide-registration/selected-epa-registered-disinfectants

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