Purified water system validation

     

Purified Water system validation

water system validation shall be done in three phases.

Phase -1

Phase -2

Phase -3

Phase -1

A test period of 2-4 weeks should be spent for monitoring the system intensively. During this period the system should operate continuously without failure or performance deviation.Water cannot be used for pharmaceutical manufacturing in this phase.The following should be included in testing approach.

·       Under take chemical & microbiological testing in accordance with a defined plan.

·       Sample incoming feed water daily to verify its quality.

·       Sample each step of purification process daily.

·       Sample each point of use daily.

·       Develop appropriate operating ranges.

·       Demonstrate production and delivery of product water of required quantity and quality.

·       Use and refine the SOP’s for operation,maintenance,sanitization and trouble shooting.

·       Verify provisional alert and action levels.

·       Develop and refine test failure procedure.

Phase -2

A further test period of 2-4 weeks. Sampling scheme will be same as  Phase – 1.Water can be used for manufacturing process in this phase.

Approach should also

·       Demonstrate consistent operation within established ranges.

·       Demonstrate consistent production & delivery of water of required quality and quantity.

Phase - 3

Phase 3 runs for one year after satisfactory completion of phase-2.Water can be used for manufacturing process during this process.

Objectives & Features of Phase -3

·       Demonstrate extensive reliable performance.

·       Ensure that seasonal variations are evaluated.

·       The sample locations, sampling frequencies and test should be reduced to the normal routine pattern based on established procedures proven during Phase -1 & phase - 2.

Specification :

Test	Specification
Description	A clear colourless odourless liquid.
pH	Between 5.0 and 7.0.
Conductivity	Stage-1: Not more than 1.3 µS/cm (online).                             ( or) Stage-2: Not more than 2.1 µS/cm(off-line). Stage-3: If the conductivity result is greater than 2.1 µS/cm, then proceed as in table - pH and conductivity requirements.
Total Organic Carbon	Not more than 500 ppb
Nitrates	Not more than 0.2 ppm
Heavy Metals	Not more than 0.l ppm
Total Aerobic Microbial  Count	Not more than 100 CFU/mL
Specified Pathogens
Test for Escherichia coli	Shall be absent.
Test for Salmonella species	Shall be absent.
Test for Staphylococcus aureus	Shall be absent.
Pseudomonas aeruginosa	Shall be absent.