Catalogue of GMP verification system solutions for purified water of pharmaceutical factories 1 Overview 2 Purpose 3 Validation scope and basis 4 Validation organization and responsibilities 5 Validation cycle and validation schedule 6 Validation items and methods 6.1 Pure
Confirmation of installation of chemical water system 6.2 Confirmation of operation of purified water system 6.3 Confirmation of performance of purified water system 7 Verification results and evaluation 8 Training of verification scheme 9 Verification record 1 Overview of our company's purification
Water system consists of raw water tank, raw water pump, quartz sand filter, activated carbon filter, resin softener, security filter (5µm), primary reverse osmosis device, ion exchange bed, security
It consists of precision filter (0.22µm), purified water tank, ozone generator, microporous membrane filter (0.22µm), purified water delivery pump, UV sterilizer and other equipment. Raw water via raw water tank,
Quartz sand filter, activated carbon filter, resin softener, primary reverse osmosis device, ion exchange bed, security precision filter, enter pure water tank and pass through microporous membrane filter
(0.22µm), supplied to the workshop after UV lamp sterilization. The purified water system is now validated. Purified water system process raw water enters raw water tank raw water pump manual quartz sand filter front and back
Cleaning water discharge Manual activated carbon filter Positive and negative washing water discharge regeneration device (salt tank) Resin softener Regeneration cleaning discharge 5μm Security filter ROⅠ High pressure water pump RO membrane group cleaning equipment
A primary reverse osmosis system, a primary concentrated water discharge regeneration device (acid-alkali tank), ion exchange bed regeneration, cleaning, emission, ozone sterilization, 0.22μm security precision filter, pure water tank, 0.22µm micropore
Filter purified water delivery pump, UV sterilizer workshop, each water point, purified water storage tank, total return water, second workshop, aluminum-plastic packaging room, second workshop, particle packaging room, 0.22μm filter delivery pump, second workshop
Laundry room, second workshop, powder inner packaging room, ultraviolet lamp, second workshop, containers with clean storage, second workshop, bottle washing room, first workshop, containers with clean storage, pre-processing workshop, powder collection room, second workshop, aluminum-plastic packaging
Room 2 Workshop Drying Room 1 Workshop Laundry Room 2 Workshop General Mixing Room Pre-processing Workshop Container Cleaning Store 2 Workshop Pill Making Room 2 Workshop Drying Room 1 Workshop Tool Cleaning Storage Room 2 Workshop
Combining room pre-processing workshop, tool cleaning storage room, second workshop, crushing room, first workshop, syrup dispensing room, second workshop, silica gel drying room, second workshop, granulation room, second workshop, pulping room, second tablet pressing room, one
Workshop tincture front room 1 workshop syrup filling room 2 workshop coating room 2 workshop tool cleaning storage room 1 workshop tincture dispensing room 1 workshop tincture filling room 1.2 functions of each part of the system
1.2.1 Raw water pretreatment equipment and functions 220.127.116.11 The quartz sand filter is filled with selected quartz sand and manganese sand, which can filter out particulate impurities and suspended matter in the raw water and some heavy gold
Is an ion (such as: iron, etc.), to control the turbidity of water and sludge pollution. 18.104.22.168 Activated carbon filter is filled with activated carbon to remove dirt and adsorb organic matter; it can also remove odor and reduce
Low chroma and residual turbidity. 22.214.171.124 The resin softener filled with cation resin mainly removes calcium and magnesium ions, prevents scaling on the reverse osmosis membrane, and avoids pollution as much as possible.
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