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Home > Products > High Purity Water System > EDI ultrapure water equipment

EDI ultrapure water equipment

Payment Type:
T/T,Paypal,Western Union
Incoterm:
FOB,CFR,CIF,EXW
Min. Order:
1 Bag/Bags
Delivery Time:
60 Days
Transportation:
Ocean
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Overview
Product Attributes

Model No.EDI-10T

Supply Ability & Additional Informations

TransportationOcean

Payment TypeT/T,Paypal,Western Union

IncotermFOB,CFR,CIF,EXW

Delivery Time60 Days

  1. EDI ultrapure water equipment Purified water injection equipment 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.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,EDI ultrapure water equipment 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.

  2. Finally, and possibly the most important consideration, is the risk assessment or level of quality that is desired. It should be recognized that different products require different quality waters. Parenterals require very pure water with no endotoxins. Topical and oral products require less pure water and do not have a requirement for endotoxins. Even with topical and oral products there are factors that dictate different qualities for water. For example, preservatives in antacids are marginally effective, so more stringent microbial limits have to be set. The quality control department should assess each product manufactured with the water from their system and determine the microbial action limits based on the most microbial sensitive product. In lieu of stringent water action limits in the system the manufacturer can add a microbial reduction step in the manufacturing process for the sensitive drug product(s).
  3. I. SYSTEM DESIGN
  4. 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.
  5. 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.
  6. EDI ultrapure water equipmentThe process flow

High purity water equipment


Purified water injection equipment

Purified water injection equipment


Product Categories : High Purity Water System

Company Overview
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.
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