GENERAL METHOD FOR CHECKING OF BACTERIOLOGICAL QUALITY OF WATER FOR PHARMACEUTICALS

OBJECTIVE :- To sample and test the factory water supplies at various stages of processing,

storage and distribution in order to establish the quality of the water used directly or indirectly

in product manufacture

PRECAUTIONS :-

1 Use gloves when hot water is to be sampled

2 While sampling take care to avoid contamination

PRECEDURE :-

A) MONITORING -----------LOCATION

a) Main water source------- Tap point facility inlet

b) Storage tank ---------------- water from the storage tank

c) Demineralised Water (DM )---- Washing area of ointment section

d) Distilled water (DW)----------Distilled water still in QA Department

e) Tap ----------------------------Drinking water point


B) SAMPLING :-

a) Tap water main water suplly :- Unplug the sterile 500 ml capacity sample bottle containing

1 ml of sterile 3 % Sodium thiosulphate solution Fill the bottle with 3/4 th its capacity

Plug the bottle immediately with cotton plug

b) D/M & D/W point :- Unplug the sterile 500 ml capacity sample bottle Fill the

bottle with 3/4 th its capacity Plug the bottle immediately with the cotton

c) Storage tank :- Let some water run through out let of storage tank , and then collect from all pints in storage tank Unplug the sterile 500 ml capacity sample
bottle Fill the bottle with 3/4th its capacity Plug the bottle again with the cotton

C) NOTE :- a) Hot samples should be cooled to ambient temperature before filteration
b) Samples should be tested within 1 hour of sampling or if cannot be tested within
1 hour

D) METHOD :-
1 Method used is membrane filteration method
2 For D/W 10 ml of sample is filetered and in case of raw water , storage and tap water
100 ml of sample is filtered

3 Remove the cap of the filter cone and transfer the above mentioned volumes for

mentioned samples and filter it through 045 u filter paper Following filteration

transfer the membrane filter using sterile forceps to the sterile petridish Pour

sterile molten and cooled to not more than 44 deg C Soybean Casien Digest

Agar medium Rotate the medium to cover the entire membrane filter , allow it
to set

4 Filer the second set of sample and filter the sample with volumes mentioned above
of the mentioned samples and filter it through 045 u filter paper Folowing
filteration transfer the membrane filter using sterile forceps into the 100 ml of sterile
Soybean Casien Digest Medium
5 Incubate the plates at 35 - 37 deg C for 72 hours and the media tubes for minimum
period of 24 hours

6 Observe the plates every 24 hours till the completion of 72 hours and the tubes for
48 hours

7 In case of tubes if there is a evidence of growth after 48 hours of incubation proceeed
as tabulated for detection of pathogens viz Escherechia coli , Salmonella spp
Staphylococcus aereus, Pseudomonas spp resp In case there is no evidence of
growth after 24 hours of incubation it indicates the absence of pathogens

8 After 72 hours of incubation examine all the membrane filter Count the total colony
forming units per membrane and calculate the results in cfu/ml and record

9 After proceeding for the pathogen detection test record the observations

10 Using autoclaved water samples, prepare negetive controls for membrane filteration
for each days of testing Transfer the membrane filters into the sterile pertidish and
pour 20 ml of sterile soybean Casien digest agar medium, cool it and incubate it
along with the test samples Similarly the autoclaved water sample is filtered and
the membrane filter transferred using sterile forceps into the 100 ml of Sterile
Soybean casien digest medium Incubate them at 35- 37 deg c for 72 hours and
48 hours resp


ACTION TO BE TAKEN IN CASE OF NON COMPLIANCE /DEVIATION :-
a) Check for proper technique of sampling and test method to rule out external

or personal contamination

b) Report to the Production Head to take necessary steps to disinfect the source where
the pathogen has been detection

c) Resample the source and check again for pathogens so as to assure that the
pathogens are completely removed

Types of water-------Location----------------------------Frequency
a)Main water source ---Tap point ------------------------ As per requirement

b) Storage tank----Water from the storage tank---As per requirement

c) Demineralised Water (DM )--Washing area-----As per requirement

d) Distilled water (DW)---Distilled water ----------- As per requirement

e) Tap water -----Drinking water point in Canteen---- As per requirement



Standard operating procedure SOP for microbiology and aseptic techniques for manufacturing of sterile dosage forms injections

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