Water System Validations & Monitoring

Water is a most commonly raw material used in the pharmaceutical manufacturing process. High-quality water is important for the manufacturing of pharmaceuticals as well as the validation of manufacturing process. Low quality of water can lead to product degradation, product contamination, and loss of product and profit. Proper pharmaceutical water system must:

1. Comply with pharmacopoeia requirements;

2. Have proper sampling system from correct points with appropriate frequency;

3. Troubleshoot common contamination problems;

4. Consistently produce water that meets industry standards for quality.

So water system must be validated to ensure the consistent production of high quality water.

We also recommend routine monitoring of the water system to ensure further compliance with the manufacturer’s criteria. Water tests are designed for assessment of microbial content and chemical impurities in water.

Our Water System Validation Service

• Test Objects
  • Source water
  • Process water
  • Purified water
  • Potable water
  • Deionized water
  • Water for injection
  • Sterile water for injection, inhalation, irrigation
  • Sterile bacteriostatic water for injection
• Determine Quality Attributes
• Develop Validation Protocol

  The validation protocol includes process equipment, critical process parameters, product characterisitcs, sampling plan, test data to be collected, number of validation runs and acceptable test results.

• Conduct Validation Procedures

  The general procedures of water system validation including:

  • Establishing standards for quality attributes and operating parameters;
  • Defining system and subsystem; Selecting equipment, control and monitoring technologies;
  • Developing an Installation Qualification (IQ) stage consisting of instrument calibration and inspection;
  • Developing an Operational Qualification (OQ) stage containing tests and inspection for verification of equipment, system alerts and controls;
  • Establishing alert and action levels;
  • Developing a Performance Qualification (PQ) stage for the confirmation of the appropriateness of critical parameter operating ranges;
  • Completing protocols and documenting each step.

Fig. 1 Water system validation life cycle. (Jadhav, 2009)

• Produce Validation Report
• Conduct Failure Investigations

Our Water Monitoring Service

• Develop Water System Monitoring Plan
• Collect A Representative Amount of Water for Testing
• Monitor Microbiological, Chemical and Physical Characteristics
  • Microbiological parameters include bacteria, viruses and parasites.
  • Chemical and physical parameters include metals, anions, chlorine and turbidity.

  We will use equipment to detect conductivity and TOC for the water scanning. TOC is a highly sensitive test method for gross screening of organic and inorganic material in water, typically indicating organism presence in high counts. The conductivity is the major quality attribute of water by which inorganic impurities can be detected.

STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks with extensive expertise. If you have additional questions about Water System Validations & Monitoring or would like to find out more about our services, please feel free to contact us.

Reference

• Jadhav, V. M., et al. "Validation of Pharmaceutical Water system: A review." Journal of pharmacy research 2.5: 948-952 (2009).