Water System In Pharma
“Water”- The only source for the survival of living organisms. I cannot even think what will be without water. In the same way, pharmaceutical companies also require water for medicine use and for other purposes. Hence, this post is to know the water system in pharma. The solid dosage forms require water for equipment and accessories to clean. However, for sterile dosage forms, water is a prerequisite. As the 95% and above composition of the sterile dosage form is “water” only. But the water directly received from the corporation or from the borewell is not used. The water is treated and then it is used. The water after treatment is called water for pharmaceutical use. Before use, the water is being tested according to type and respective specifications. Eq. purified water, potable water, and water for injection.
This was a part of the introduction and now we shall go directly to our today’s topic i.e. water for pharmaceutical use.
In every pharmaceutical industry, a water system is available. This is where water for pharmaceutical use is prepared. We will understand this in a stage-wise manner.
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Water System In Pharma
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Source water:
The source water is the water from where the pharmaceutical industry received water for further water treatment. The source water includes water received from IDC (industry development corporation), borewell, well, etc.
Raw water:
This raw water is stored in an underground tank and/or as per the storage capacity/type designed by the industry. Before storage, the water is 1st filtered by a quartz filter and then it is stored in the storage tank. In this storage tank, chlorine and alum dosing are being done for water initial purification and for preparation of potable water.
Potable water
The raw water is then treated with sodium metabisulphite for water purification. This potable water after chemical purification is filtered through a series of filters (20 µ, 10 µ, and 5µ) to remove the unwanted particles, dust particles from the water. This water is tested periodically to verify the generated potable water is fit for usage. For testing, both criteria of chemical and microbiological analysis is considered.
Purified water:
The potable water is used as feed water to generate the purified water. Purified water undergoes ionization to remove cations and anions from the water. Again, this water is passed through catpol for adjusting the pH of water. After adjusting pH, the water is then passed through UV sanitization, to kill the microorganism present in the water. The next stage is the final stage of filtration of the water and is passed through the 5 µ, 1 µ, and 0.22 µ filters. This filtered water is called Purified water. The purified water is then stored in the purified water storage tank in recirculation.
Why purified water is continually recirculated? Why water for pharmaceutical use is recirculated continuously?
As it is purified water, it should not be stagnant. Because stagnant water increases the chances to develop a film that increases microbial growth. Hence to overcome the stagnancy, the purified water is continually circulated throughout the loops.
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Water for injection (WFI) (Water System In Pharma)
The full and final stage of Water processing is the generation of WFI i.e. water for injection. The water for injection is the primmest pre-requisite of the sterile dosage form in the manufacturing industry. The water for injection is used for all parenteral, liquid sterile dosage forms, ophthalmic dosage forms, microbiological testing activities, and for pure steam generation systems, etc.
Like purified water, the WFI is also required to maintain recirculation with a temperature above 80°C. The conductivity, velocity, TOC, pH, and temperature should be monitored.
WFI system and purified water system requirement:
In the WFI distribution loop, there should not be a dead leg; as a dead leg increases the chances of microbial growth.
As per the good engineering practices requirement, the slope of the WFI distribution line should be maintained at 1:100 proportion. After installation, the WFI distribution line operating parameters should be challenged. As the WFI is used as a vehicle in sterile dosage form, it is considered a direct contact part. Hence all the accessories/equipment prepared for WFI generation, storage, and distribution should be made up of SS316L. This is to avoid corrosion inside the metal pipeline.
The roughness value (RA level) should be measured during the qualification phase. The connected equipment like heat exchanger, multicolumn distillation plant, pure steam generator, recirculatory pump, distribution line, dumping valves, storage tank, actuator valves, sensors should be challenged during the qualification phase of the water system. All the welding joints should be orbital welded. The Boroscope of the pipeline should be ensured.
The performance phase of the WFI system should be phase-wise. In totality, the performance qualification phase lasts for a complete year.
Conclusion on WFI Usage Requirement:
- Before usage of WFI for batch processing activity, the WFI parameters have to be challenged for chemical as well as microbial parameters.
- For monitoring of WFI parameters, there should be a tracking schedule. The WFI results trending shall be done periodically. Unless and until the water is satisfactory, the batches manufactured cannot be released.
- In a water system, periodic water system sanitization procedures are developed and should be maintained.
Reference:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3482709/#:~:text=WHO%20has%20prescribed%20a%20provisional,relaxation%20for%20maximum%20permissible%20level.
https://en.wikipedia.org/wiki/Drinking_water_quality_standards
http://www.swissgroupworld.com/project-details/multi-column-distillation-plant-manufacturer/
Very nice information for fresher to join newly in pharmaceutical industry
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