Purpose:
The purpose of this SOP is to provide written
guidelines for Water monitoring system in Pharmaceutical Industries.
Procedure:
For monitoring water system first select the water
points which are the guard points of water system.
Decide the necessary tests to be carried out to know
the quality of water.
The frequency of testing quarterly or change in system
Following is the chart which about testing points,
tests to be carried out and frequency of testing.
|
Sr. No.
|
Sampling point
|
Chemical testing
|
Microbiological testing
|
LAL
(BET)
|
|
|
Bioburden
|
Pathogens
|
||||
|
1
|
Potable water
|
Every day
|
Weekly
|
Monthly
|
N.A.
|
|
2
|
After ACF
|
N.A.
|
Weekly
|
N.A.
|
N.A.
|
|
3
|
After MB
|
N.A.
|
Weekly
|
N.A.
|
Weekly
|
|
4
|
After HUF (DM)
|
Every day
|
Weekly
|
Monthly
|
Weekly
|
|
5
|
After RO
|
N.A.
|
Weekly
|
N.A.
|
Weekly
|
|
6
|
WFI
|
Every day
|
Every day
|
N.A.
|
Every day
|
|
7
|
Boiler Water
|
Weekly
|
N.A.
|
N.A.
|
N.A.
|
|
8
|
After softener
(Feed water for RO)
|
Every day
|
N. A.
|
N.A.
|
N.A.
|
Chemical testing carried out
at different points
MIDC WATER (Potable
Water)
- Description
- Odour
- Taste
- PH
- Hardness (as CaCO3)
- Chloride (as Cl)
- Sulphate (as SO4)
- Residual Free Chlorine
- Conductivity
- Residue on evaporation
- Pathogenicity test
Feed water for RO
- Suspended solid / TDS
- Free Chlorine
- Iron
- Heavy metals
- PH
- Silt density index
After HUF (DM)
- Description
- Acidity or alkalinity / pH
- Ammonium
- Calcium and Magnesium
- Heavy metals
- Chloride
- Nitrate
- Sulphate
- Oxidisable substances
- Residue on evaporation
- Conductivity
WFI
- Description
- Acidity or alkalinity / pH
- Ammonium
- Calcium and Magnesium
- Heavy metals
- Chloride
- Nitrate
- Sulphate
- Oxidisable substances
- Residue on evaporation
- Conductivity
- TOC (Total Organic Carbon)
Boiler water
- Clarity
- pH
- Hardness
- TDS (Total Dissolved Solids)
