Model No.: EDI-5000L
High Purity Water System This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances.High Purity Water System Purified water injection equipment It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The Guide To Inspections of Microbiological Pharmaceutical Quality Control Laboratories (May, 1993) provides additional guidance.
I. SYSTEM DESIGN
Purified water injection equipmentOne of the basic considerations in the design of a system is the type of product that is to be manufactured. For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used. This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and Reverse Osmosis (RO) filtration are the only acceptable methods listed in the USP for producing Water for Injection. However, in the bulk Pharmaceutical and Biotechnology industries and some foreign companies, Ultra Filtration (UF) is employed to minimize endotoxins in those drug substances that are administered parenterally.
For some ophthalmic products, such as the ophthalmic irrigating solution, and some inhalation products, such as Sterile Water for Inhalation, where there are pyrogen specifications, it is expected that Water for Injection be used in their formulation. However, for most inhalation and ophthalmic products, purified water is used in their formulation. This also applies to topicals, cosmetics and oral products.
High Purity Water System
Jiangmen Leonard Industrial Machineries Co., Ltd.
Leonard Industrial is with more than 15years experience for designing, manufacturing and delivering of Water Treatment and beverage filling packing machineries, we can provide complete solution of bottle mineral water and beverage factory plant including workshop GMP area construction. Now GMP designing and construction is our new extend business for supplying complete plant of customer who have full dependence for us. We can get most competitive direct channel price from original manufacturers of GMP materials locating all area of China to deliver together by us and built professional team for GMP work-shop designing and installation. We are professional solution provider for GMP Clean System projects, we can represent high quality and professional standard for China GMP clean room Project and related equipment. We insist principle of "win-win business" and "exceed expectation" to serve our customers, and keeping our business idea of "integrity management, intentions services and small profits but quick returns" for our marketing process. We have professional design team and installation team for providing complete solution for GMP workshop designing, construction and operation for different industries regarding Food & Beverage Products, Electronic Items, Photoelectricity Products, Medical Products, laboratory and Hospital Operating Room. We do most suitable customize design for each GMP clean workshop based on customer's actual requirement and different factory location and actual setting.
- Company Name: Jiangmen Leonard Industrial Machineries Co., Ltd.
- Product/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
- Year Established: 2019
- Total Annual Sales Volume (Million US $): US$1 Million - US$2.5 Million
- Export Percentage: 61% - 70%
- Total Annual Purchase Volume (Million US $): US$1 Million - US$2.5 Million
- Contact Person: Mr. Ben Liu
- Tel: 86-750-3094316
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