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Why Water Validation is Important in a Pharmaceutical Water System?

Validation ofu00a0thepharmaceutical water systemu00a0is important for various reasons. The validation is done to ensure that the water treatment facilities produce high-quality water throughout the production process. Validation is important to maintain the consistency and effectiveness of water treatment systems. Through validation, the pharmaceutical organizations can comply with the cGMP standards. Validation provides documented reports for the step-by-step processes that may be taken to fulfil the goal of the production process or to obtain the end product. To know more go through the PPT

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Why Water Validation is Important in a Pharmaceutical Water System?

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  1. Why Water Validation is Important in a Pharmaceutical Water System? TSA Water Systems

  2. Water is one of the most vital ingredients used in pharmaceutical applications for the formulation, preparation and synthesis of pharmaceutical products. it is used for both preparations of pharmaceutical products and cleaning of pharmaceutical equipment through CIP and SIP processes. Validation of the pharmaceutical water system is important for various reasons. The validation is done to ensure that the water treatment facilities produce high-quality water throughout the production process. Validation is important to maintain the consistency and effectiveness of water treatment systems. Through validation, the pharmaceutical organizations can comply with the cGMP standards. Validation provides documented reports for the step-by-step processes that may be taken to fulfil the goal of the production process or to obtain the end product. Pharmaceutical water system validation consists of four steps. These are design qualifications, installation qualifications, operational qualifications and performance qualifications. In the design qualification stage, the schematic diagram of mechanical, electrical and water flow arrangements are studied thoroughly and it is checked whether the installation is done according to the schematic or not. Also, it is supervised to ensure whether the alarm systems, safety devices, control devices and purification systems are installed or not.

  3. In the installations qualification stage, it is ensured whether the pharmaceutical water system meets the design stage requirements and has been correctly installed or not. This stage involves the generation of installation protocol, inspection and test plan for the water system. In this stage, utilities such as compressed air, feed water, electricity and steam are checked thoroughly. Next comes the operation qualification stage. This stage consists of various inspection and test procedures to verify the reliability of operations, control systems and alert systems. Parameters such as pressure, endotoxin level, the pH level of water, temperature, conductivity and microbial concentration are checked. Last comes the performance qualification stage. This stage involves a variety of tests that are designed to verify the consistency and performance of the system such as product tests and intermediate tests. Contact us to know more.

  4. THANK YOU!

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