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Water System Validation

Water System Validation
Water In Pharma
Water Tests
Water System Validation

Water System Validation Service

Our team in Treat Padideh Sanat assist you to step by step implement water system validation according to WHO, FDA, and PIC/S guidelines.

Our approach in water system validation is to give you the best and cost-effective solutions to get GMP approval.

Depends on each company size and production, the steps and program will be different but typically our water system validation includes:

  • Water system Audit and gap analyzing
  • Providing gap analyzing form and CAPA handling program
  • Recommendation, consultant and CAPA implementation
  • Periodic audit to ensure the effectiveness of CAPA
  • Recommendation to improve WFI and purified water system
  • Providing and review validation documents
  • Assisting and implementation of 3 phases of validation
  • Providing and review protocols and reports of validation
  • Assisting with you in regulatory inspection

For more information about our Water System Validation Service, click the button below.

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Water In Pharma

Importance of Water in the pharmaceutical Industry

Water is one of the most used components in the pharmaceutical industry and its wide range consists of raw material, starting material to the production process, and formulation. because of its chemical attribute, structure and hydrogen bonds it can absorb or dissolve other components. This means that despite water’s benefit, it can cause contaminants and affect the product quality, therefore, manufacturer companies should focus on it.

Contaminants may have a risk by themselves. Additionally, when they react with the other components their potential risk can be higher which can represent hazards to patient safety. In conclusion, contaminants in the pharmaceutical industry can have hazards and put patient safety at risk as well as financial loss.

Control of the water throughout the production, storage and distribution to ensure that the required quality met is one of the major parameters in the pharmaceutical industry. Also, the capacity of the water system should be designed to acquire the routine usage of water and peak demands. Designing of the water system can give this opportunity to extend its capacity and modifying. Regardless of the system’s size and capacity, all of them should have the flow and returning systems to ensure consistency in the quality of water production.

Water Tests

3 Types of Tests

To obtain this quality, all parts and process of water production muse be validated and due to standard and regulations including the following tests:

  • TOC test (Total Organic Carbon)

this test indicates the number of organic compounds throughout measuring the amount of carbon in water. This compound usually comes from source water, system’s equipment, etc.   depends on each standard it has some acceptance criteria. Performing this test allows monitoring and ensuring that the purification of the system is functioning properly.

  • Conductivity test

Conductivity Test: this test shows the purification of water through measuring ion present in water as well as water contamination.

  • Microbiological test

This test looks for organisms as a sign of fecal contamination. Routine monitoring can indicate the unappropriated trends and subsequently preventing any risk to the final product, process and consumer safety.

For experts and managers who eager to learn more about water system validation, we execute training courses.

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Training Courses
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