SOP for Sampling and Testing Schedule of Water for Injection and Clean Steam

1.0 OBJECTIVE

To define the schedule & frequency for testing, locations for sampling and type of analysis required to be carried out for the water for injection and clean stem for monitoring & assurance of its quality.

2.0 SCOPE

This procedure is applicable for sampling and analysis of water for injection and clean steam.

3.0 RESPONSIBILITY

3.1 Doing: Tech.Assistant ( Microbiologist)
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Remark: Ensure visually that container for sample collection is washed and dried properly.
5.1 Collection of WFl sample for chemical analysis.
5.1.1 First collect the sample for chemical analysis.
5.1.2 Flush water from the tap for 30 seconds.
5.1.3 Rinse the sampling bottles three times with actual sample before sampling for chemical analysis.
5.1.4 Collect approx. 500 ml sample of WFl in a bottle
Note: Sample should be filled up to the neck of sampling bottle for chemical analysis.
This is to ensure that air in the empty portion of the sampling bottle should not get dissolved in the water sample.
5.2 Collection of WFI sample for Total Organic Carbon (TOC) test.
5.2.1 Use aiairtightontainer for the collection of WFl sample for TOC analysis.
5.2.2 Wash the container prior to sampling with 2N HCl for 2-3 times.
5.2.3 Follow pt. 5.1.2 & then 5.1.3.
5.2.4 Collect about 60-70 ml of sample & close the sample container tightly.
Note : (1) Take precaution to prevent atmospheric carbon dioxide being dissolved in sample.
(2) In case if TOC analyser is out of order, the sample can be release on base of Oxidisable substance test Result.
5.3 Collection of WFl sample for Microbiology testing.
5.3.1 Use suitable container for collection of WFl sample. This to be sterilized as under.
→ Fill the sample collection container with PW & keep the cap tightly.
→ Wrap it with wrapping/butter paper
→ Sterilise it at 121°C for 30 min.
5.3.2 Discard the PW filled in sterilized sample container just before collection of WFl sample for analysis.
5.3.3 Collect about 200ml of WFl sample in sterilized container and close tightly.
5.4 Collection of WFl sample for Bacterial Endotoxin Test (BET)
5.4.1 Use Depyregenerated glass container for collection of WFl sample.
5.4.2 Collect about 15ml WFl sample for BET.
Remark : (1) Send the sample within 1hr. to microbiology Lab for BET & Microbiological test.
(2) Perform the Microbial test within 1 hr. In case of probable delay, preserve the sample in freeze but this storage condition is allowed maximum upto 48hr. Within the time limit test should be started.

5.5 Collection of clean steam sample.
5.5.1 Container for collection of sample & sequence for sample collection are to be followed same as per mentioned in pt. 5.1, 5.2, 5.3 & 5.4.
5.5.2 Take a large capacity glass beaker (500/1000 ml) and fill it with cold water.
5.5.3 Place the container for clean steam sample collection in it.
5.5.4 Open the sample container & insert the clean steam outlet in it.
5.5.5 Open the valve & allow to run the clean steam flow in it.
5.5.6 Continue it till sufficient quantities of condense steam collected. Then close the container.
5.6 For total microbial count, collect approximate 200 ml sample in sterilized Bottle.
5.7 For Bacterial Endotoxin test collect, approximate 15 ml sample in washed, dried and Depyrogenated tube. As per S.O.P.
5.8 Mark the samples carefully with type of water, location and date.
5.9 Send the samples within one hour after collection to microbiology laboratory for analysis.
5.10 For microbial test, analyse the sample within 1 hour. In case of probable delay in testing, store the sample in freeze for maximum 48 hrs. and within this time limit analysis should get started.
5.11 Water for injection and clean steam samples should be analyse as per EP Specification
5.12 Frequency of testing.

Type of Water	Type of Testing	Frequency of testing
W.F.I 80 oC/10oC	Complete Analysis	Storage Tank             : Daily Insulin Mfg.Room     : Daily Ampoules Mfg.room : Once in a week
W.F.I. 55°C	Complete Analysis	Storage Tank  :  Daily
	PH, Conductivity, TVC BET & TOC	User End Points : Once in a week
Clean Steam	Complete Analysis	Once in a week to cover all the taps

6.0 ABBREVIATIONS

SP = Sampling Point
% = Percentage
TOC = Total organic carbon
BET = Bacterial Endotoxin
TVC = Total viable count
WFI = Water for Injection
Mfg. = Manufacturing
°C = Degree centigrade
HCL = Hydrochloric Acid
PW = Purified water

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