Validation of water system in GMP workshop for eye drops
Validation of water system in GMP workshop for eye drops
GMP requirements for process water: drinking water is used for the initial washing of containers, equipment and purified water sources, and the requirements must meet the standards. Water source for preparing water for injection, washing eye drop bottles,...
Text label: eye drops GMP pharmaceutical cleanroom, water system verification, design, construction and installation
Validation of water system for eye drops GMP workshop
GMP requirements for process water: drinking water is used for the initial washing of containers, equipment and purified water sources, and the requirements must meet the standards. The water source for preparing water for injection, the initial washing water for washing eye drop bottles and ingredients, and pure steam prepared from purified water can be used for sterilization of materials, containers and culture medium; sterilized water for injection is used for the preparation of eye drops by aseptic operation. Water for ingredients and cleaning water for eye drop bottles and ingredients utensils. Purified water preparation devices include electrodialyzers, ion exchange columns, mechanical filtration devices, etc. Check the design drawings and other materials to check whether the installation of instruments, electrical appliances, water supply, connecting pipes, and filtration devices meets the design requirements; the pipes should be made of stainless steel with inner walls Smooth, easy to clean and sterilize, adopt diaphragm valve, argon arc hot-melt welding, pressure test without leakage, pipelines are cleaned with purified water, lye, steam sterilized; conductivity meter, PH meter and other instruments for measuring water quality and purified water treatment device The pressure gauges, flowmeters and other instruments on the device should be calibrated regularly.
The operation confirmation of the purified water system is an actual operation test to prove whether the system can meet the design requirements and production process requirements. All equipments are checked one by one, and various parameters are checked to confirm whether they are qualified; the purified water system is installed according to the design requirements, After debugging and running normally, and recording various parameters, the verification can be started; before sampling, flush the water outlet, and collect water samples from the water storage tank, the total water outlet, the total return outlet, and each point of use; the purified water quality test mainly includes: Chemical indicators, physical indicators, microbial indicators. The installation confirmation of the water for injection preparation device is mainly based on the production requirements, checking whether the installation of water treatment equipment and piping system is qualified, checking the calibration and operation of instruments, and writing maintenance procedures; Whether the installation meets the design requirements; the pipeline should be made of 316L stainless steel, the inner wall is smooth, easy to clean and sterilize, the diaphragm valve, argon arc hot-melt welding, pressure test without leakage, the pipeline should be cleaned with purified water, lye, steam disinfection, etc. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and GMP workshops.
The operation confirmation of the water injection system in the GMP workshop is an actual operation test carried out to prove whether the system can meet the design requirements and production process requirements. The water for injection system is installed, debugged and operated normally according to the design requirements. After recording various parameters, the verification can be started; before sampling, flush the water outlet, and collect the water in the water storage tank, the total water supply port, the total water return port, and each point of use. The water quality test of water for injection mainly includes chemical indicators, physical indicators and microbial indicators.
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