SS316L Pharma Purified Water System FDA USP cGMP GMP Standard

Purified Water Systems:

*For purified Water Systems, microbiological specifications are not as clear. US Pharmacopeia, USP XXII specifications, as it complies with Federal Environmental Protection Agency regulations for drinking water, are recognized as being minimal specifications. There have been attempts by some to establish meaningful microbiological specifications for purified water. The CFTA proposed a specification of not more than 500 organisms per ml. The USP XXXII has an action guideline of not greater than 100 organisms per ml. Although microbiological specifications have been discussed, none (other than EPA Standards) have been established. Agency policy is that any action limit over 100 CFU/ml for a purified water system is unacceptable.

The purpose of establishing any action limit or level is to assure that the water system is under control. Any action limit established will depend upon the overall purified water system and further processing of the finished product and its use.

The USP gives some guidance in their monograph or microbiological Attributes of Non-sterile Products. It points out that, “The significance of micro-organisms in non-sterile pharmaceutical products should be evaluated in terms of the use of the product, the nature of the product, and the potential harm to the user.” Thus, not just the indicator organisms listed in some of the specific monographs present problems. It is up to each manufacturer to evaluate their product, the way it is manufactured, and establish an acceptable action level of contamination, not to exceed the maximum, for the water system, based on the highest risk product manufactured with the water.

Company Name: Shanghai ChongYang Water Treatment Equipment CO.,LTD

Email : Sales@cy-waterequipment.com

Phone:+86 15900488030 

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