Pharmaceutical Machinery of Water Treatment Station for GMP 917

Pharmaceutical Machinery Of Water Treatment Station for GMP 917

WHO good manufacturing practices: water for pharmaceutical use

1.Background to water requirements and uses
Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical
products. These include contaminants that may represent hazards in themselves or that may be able to react with intended product substances,
resulting in hazards to health.

2.General principles for pharmaceutical water systems
 Pharmaceutical water production, storage and distribution systems should be designed, installed, commissioned, qualified and maintained to ensure the reliable production of water of an appropriate quality. It is necessary to validate the water production process to ensure the water generated, stored and distributed is not beyond the designed capacity and meets its specifications.

3.Water quality specifications
the following requirements concern water processed, stored and distributed in bulk form. they do not cover the specification of water formulated for patient administration. Pharmacopoeias include specifications for both bulk and dosage-form types of water.


4.Water purification systems

Production of drinking-water
Drinking-water is derived from a raw water source such as a well, river or reservoir. there are no prescribed methods for the treatment of raw water to produce drinking-water from a specific raw water source.


Production of purified water
Any appropriate qualified purification technique or sequence of techniques may be used to prepare purified water (PW). PW is commonly produced by ion exchange, RO, ultrafiltration and/or electro-deionization processes and distillation

It should be considered when configuring a water purification system or defining user requirement specifications (URS).


Production of highly purified water
Highly purified water (HPW) can be produced by double-pass reverse osmosis coupled with ultrafiltration or by any other appropriate qualified purification technique or sequence of techniques.



Production of water for injection(s)
Some pharmacopoeias prescribe or limit the permitted final water purification stage in the production of BWFI. Distillation is the preferred technique; it is considered a more robust technique based on phase change, and in some cases, high-temperature operation of the process equipment.

It should be considered when designing a water purification system and defining URS.

5.Water storage and distribution systems
this section applies to WPU systems for PW, BHPW and BWFI. the water storage and distribution should work in conjunction with the purification plant to ensure delivery of water of consistent quality to the user points, and to ensure optimum operation of the water purification equipment.


Materials that come into contact with systems for water for pharmaceutical use
the materials that come into contact with WPU, including pipework, valves and fittings, seals, diaphragms and instruments.
When stainless steel is used it should be at least grade 316. In general 316L or a higher grade of stainless steel is used.

6.Requirements for water distribution pipework
-General
the distribution of BPW, BHPW and BWFI should be accomplished using a continuously circulating pipework loop. Proliferation of contaminants within the storage tank and distribution loop should be controlled. Good justification for using a non-recirculating one-way system should be provided.

-Temperature control and heat exchangers
-Circulation pumps
-Biocontamination control techniques

Qualification
WPU, BPW, BHPW and BWFI systems are all considered to be direct impact, quality critical systems that should be qualified. the qualification should follow the validation convention of design review or design qualification (DQ), IQ, OQ, and PQ.



Company introduction:

  Introduced foreign advanced technology, combined with years of engineering experience, Sinou provide purified water system, which can meet the biopharmaceutical industry standards. This system can control the quality standards of each functional unit, while supporting the realization of preparation and extraction of Chinese and Western medicine, plant drugs, pharmaceuticals and intermediates.
 In the field of Daily-Use Cosmetics,Combine with new membrane separation technology, adopt the new CEDI technology with ion migration, can remove heavy metal ions in water and control the bacteria and microbes. The innovative technology ensures high quality of product water, which provides customers with a cost-effective and efficient solution.Unique advantage
--Comply with GMP certification standards;
--Comply with FDA certification standards, the CE certification standards, the NSF certification standards and the ASTM standard;
-- Implement the verification control system according to ISPE's pharmaceutical engineering guidance;
--From product quality to strict FAT and SAT requirements, from construction standards to acceptance of the configuration, are in line with export standards.
--The combination of CEDI ensures the water quality, and extends the decay cycle of water quality.
--Product water is far away from the secondary pollution sources;
Applications

--Tablets, capsules, oral liquid and other preparation of the finished products drugs;
--Raw materials preparation;
--The hospital's central water supply system (including the hemodialysis water, injection water, pathological biochemical water, supply room cleaning water, dental cleaning water, operating room cleaning water, maternal and infant rinse water, preparation room water, medicine decocting, pathology, physical examination center laboratory);
--Combine with new membrane separation technology, adopt ion migration, can remove heavy metal ions in water and control the bacteria and microbes;
-- The innovative technology ensures high quality of product water, which provides customers with a cost-effective and efficient solution.