Communicate with Supplier? Supplier
Ben Liu Mr. Ben Liu
What can I do for you?
Contact Supplier

The manufacture of High Purity Water System in China

2021-04-19

The manufacture of High Purity Water System in China For purified water systems, microbiological specifications are not as clear. USP XXII specifications, that 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 XXII 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. For example, purified water used to manufacture drug products by cold processing should be free of objectionable organisms. We have defined "objectionable organisms" as any organisms that can cause infections when the drug product is used as directed or any organism capable of growth in the drug product. As pointed out in the Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories, the specific contaminant, rather than the number is generally more significant.

High Purity Water System process

High Purity Water System

Jiangmen Leonard Industrial Machineries Co., Ltd.
Business Type:Agent , Distributor/Wholesaler , Manufacturer , Organization , Service
Product Range:Curtain Walls , Other Machine Tool Equipment , Repairs & Maintenance
Products/Service:Clean Room Design and Construction , Clean Room Sandwich Panel , Water For Injection Systems , Clean Room Construction Materials , High Purity Water System , Insdustry GMP Clean Room
Certificate:
Company Address:RM 1918, B Buliding, Wanda Plaza, Jiangmen City, Guangdong, China, Jiangmen, Guangdong, China

Previous: Production of Clean Room Construction Materials in China

Next: Uses of High Purity Water Systemsr

Related Products List

Home

Phone

Skype

Inquiry