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 :
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.
|
