sop for monitoring of purified water

1.0 OBJECTIVE:

The objective of this SOP is:
1.1 To lay down a procedure to monitor the quality of purified water

2.0 RESPONSIBILITY:

2.1 The Microbiologist shall be:
2.1.1 Responsible for sampling and analysis

2.3 Executive – Quality Control shall be:
2.3.1 Responsible for Checking and approving the results and trend analysis.

3.0 ACCOUNTABILITY:

Head – Quality Control

4.0 PROCEDURE:

4.1 Preparation of sample containers
4.1.1 For Chemical analysis: Clean 500 ml glass containers. Rinse with purified water.
4.1.2 For Microbiological analysis: Clean 250 ml glass containers. Rinse with Purified water.
4.1.3 Close the containers and wrap the neck securely with aluminum foils. Sterilize at 121 0C for 20 minutes.

4.2 Collection of water for Chemical/Microbiological analysis.

4.2.1 Collect one sample each for Chemical & Microbiological analysis daily as per the frequency mentioned in SOP
4.2.2 Select the points for sampling as per SOP
4.2.3 Before collection of samples, open the valve and allow the water to drain for 1 min.
4.2.4 For Chemical analysis sample, rinse the container with purified water from the sampling point and collect approximately 500 ml of water.
4.2.5 Close the containers, meanwhile continuing to allow the water to run through the valve.
4.2.6 For microbiological analysis hold the sterile containers near the valve (at the end of hose if present) unwrap the Aluminum foil and open the containers taking care not to touch the stopper or neck of the container.
4.2.7 Collect the sample in the container without rinsing and immediately close it with the stopper. Do not fill the bottle up to the neck.
4.2.8 Wrap the neck with Aluminum foil to avoid any contamination during transit.
4.2.9 Close the valve and bring both the samples to IPQA Laboratory.
4.2.10 Wipe the container dry from outside and label them with the following details,
a. Name of the sample
b. Collection point.
c. Date of collection
d. Sampler’s Name

4.2.11 Send the samples to QC Lab for analysis
4.2.12 Perform the analysis of purified water samples
1. Chemical analysis as per specification
2. Microbiological analysis as per specification.

4.2.13 Perform the analysis of water samples on the same day of sampling.
4.2.14 Record the microbiology results in the format as mentioned in SOP
4.2.15 On completion of analysis, send a copy of Certificate of Analysis to Manufacturing dept.
4.2.16 In case the sample fails in Chemical testing follow the procedure as mentioned in SOP and if it fails in microbiological testing follow the procedure as mentioned in SOP

5.0 REASON FOR REVISION:

Change in sampling plan.

6.0 TRAINING:

Trainer — Executive – Quality Assurance
Trainee — Microbiologist, Chemist and IPQA personnel.

7.0 DISTRIBUTION:

Certified Copy No. 1 : Head of Department – Quality Control
Certified Copy No. 2 : Microbiology Department.
Original Copy : Head – QUALITY ASSURANCE

sop for monitoring of purified water

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