Water sampling of raw water purified water WFI and PSG in microbiology Lab

Water sampling of raw water, purified water WFI and PSG in microbiology Lab

1.0 Objective
To lay down a procedure for water sampling of raw water, purified water, WFI and PSG in microbiology Lab
2.0 Scope
This Standard Operating Procedure is applicable for the water sampling of raw water, purified water, WFI & PSG in microbiology Lab to be followed at formulation plant of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control Department are responsible for water sampling of raw water, purified water, WFI and PSG.
3.2 Head Quality Control is responsible for the compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
QA : Quality Assurance
QC : Quality Control
No. : Number
P.W. : Purified water
R.W. : Raw water
WFI : Water for Injection
PSG : Pure Steam Generation
S.S. : Stainless Steel
Sec. : Seconds
Hrs : Hours
ºC : Degree Centigrade
IPA : Isopropyl Alcohol
5.0 Procedure
5.1 Water sampling for R.W. and P.W.
5.1.1 For sampling of water R.W. & P.W. glassware should be cleaned as per SOP No. for Cleaning

and Autoclave as per SOP No.
5.1.2 Open the sampling valve in such a way that the water should neither drip nor it should come with full force.
5.1.3 Use autoclave glass bottle for sampling of P.W. and R.W and drain the water from bottle and open

the sampling valve for 30 sec. before sampling.
5.1.4 Holding the base of the bottle fill the water sample from sampling point in such a way that the

bottle mouth should not touch the sampling port during the water sampling and water should not over flow from the bottle.
5.1.5 Replace the cap immediately after sampling and place the bottle in the same SS container/ plastic

bucket and close the lid of the SS container/ bucket.
5.1.6 Similarly sample the water from all respective sampling locations and then transfer the

SS container/bucket to the Microbiology laboratory for microbial analysis.
5.1.7 Analyze the sample as quickly as possible on arrival at the laboratory. Begin the analysis

within 3 Hours of sampling. If immediate analysis is not possible store the sample under refrigeration

at 2ºC to 8ºC for 6 hours.
5.2 Water sampling for WFI and PSG
5.2.1 For water sampling of WFI & PSG, glassware should be cleaned as per SOP No. and Depyrogenate as per SOP No.
5.2.2 Open the sampling valve in such a way that the water should neither drip nor it should come with full force.
5.2.3 Use depyrogenated glass bottle/tubes/flask for sampling of W.F.I and P.S.G and drain the water

sample for 30 sec before sampling.
5.2.4 Holding the bottle/tubes/flask with the help of holder/ tray of water sample from sampling point

in such a way that the bottle mouth should not touch the sampling port during the water sampling and

water should not over flow from the bottle/tubes/flask.
5.2.5 Replace the cap/aluminum foil immediately after sampling and place the bottle in the same

SS container/ plastic bucket and close the lid of the SS container/ bucket.
5.2.6 Similarly sample the water from all respective sampling locations and then transfer the

SS container/bucket to the Microbiology laboratory for microbial analysis.
5.2.7 Analyze the sample as quickly as possible on arrival at the laboratory. Begin the analysis

within 3 hrs of sampling. If immediate analysis is not possible store the sample under refrigeration

at 2ºC to 8ºC for 6 hours.
5.3 Precaution
5.3.1 Follow the gowning procedure at the respective area at the time of water sampling.
5.3.2 Wear the hand gloves, Nose mask at the time of water sampling.
5.3.3 Disinfectant the hand gloves with 70% I.P.A and wait till the evaporation of the I.P.A before

the water sampling.
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control

8.0 History