Pharmacy Courses

Validation of Purified Water System

The purpose of carrying out water system validation is to assure that the treatment process produces a high quality of water consistently. Water system validation is mandatory in order to study the reproducibility, consistency & effectiveness of water system. It is regulatory requirement also.

Important Tests for Validation of Purified Water Systems

1. Microbial testing:

This involves testing the water samples for the presence of microorganisms such as bacteria, viruses, and fungi. It ensures that the purified water system effectively removes or kills these microorganisms.

2. Chemical testing:

This includes testing for various chemical parameters such as pH, conductivity, total organic carbon (TOC), total dissolved solids (TDS), and specific ions like chloride, sulfate, and heavy metals. It ensures that the purified water system meets the required chemical specifications.

3. Endotoxin testing:

Endotoxins are toxic substances released by certain bacteria. Testing for endotoxins ensures that the purified water system effectively removes or reduces their presence to acceptable levels.

4. Particulate matter testing:

This involves measuring the amount of particulate matter present in the purified water samples. It ensures that the system effectively removes or filters out any solid particles present in the water.

5. Validation of sanitization procedures:

This includes testing the effectiveness of sanitization procedures used in cleaning and disinfecting the purified water system components. It ensures that these procedures adequately eliminate any potential contaminants.

6. System performance testing:

This involves evaluating various operational parameters of the purified water system, such as flow rate, pressure drop, temperature control, and alarm systems. It ensures that the system operates within specified limits and performs consistently over time.

7. Validation of critical control points:

Critical control points (CCPs) are specific stages or processes within the purified water system where control measures are applied to prevent or eliminate hazards. Testing and validation of CCPs ensure that these measures are effective in maintaining water quality.

8. Validation of monitoring systems:

Monitoring systems such as sensors, meters, and alarms are used to continuously monitor various parameters in the purified water system. Testing and validation of these systems ensure their accuracy and reliability in detecting deviations from desired conditions.

9. Water sampling techniques:

Proper sampling techniques need to be validated to ensure representative and accurate water samples are collected for testing. This includes validation of sampling locations, sampling methods, and sample handling procedures.

10. Validation of system maintenance procedures:

Regular maintenance activities such as filter replacement, cleaning, and calibration of equipment need to be validated to ensure they are performed correctly and do not introduce any contaminants into the purified water system.

Read also: Designing and Engineering of Pharmaceutical Water System

Previous Post Next Post