Microbiological Analysis of Water & its SOP

[Microbiological Analysis of water; this article describes the basic procedure of Microbiological Analysis of water as per different guidelines]

Purpose

Microbiological Analysis of water; To confirm that different type of Water used for different drug processing, cleaning and drinking purpose meets the required Pharmacopoeia & In-house specifications.

Scope

This SOP applies for sampling and analysis of all types of water used in this plant.

Definition/Abbreviation

None

Responsibilities

The roles and responsibility is as follows

Lab Attendant

Sample collection of different types of water.

Executive / Sr. Executive, Microbiology

Verify, Monitoring of Sample collection, analysis of Water, and test preparation of report accordingly.

Asst. Manager/Manager, Microbiology

• Confirm sampling, analysis, documentation, and application of appropriate technical information.
• Review of this SOP that the whole procedure is technically informative and in execution condition.

Head of Quality Assurance

Take initiate to the approval of SOP

Procedure

Instructions

• Disinfect the outer surface of the sampling point with the help of 70% IPA.
• Wear sterilized latex-free gloves and an appropriate mask. Never forget to wear a beard mask where required.
• Never open the sample container before & after the collection of a specific sample.

Sample Collection

• Select the sampling point as per the schedule of the Water Test accordingly.
• Before sampling sterilized the sampling containers for microbiology test at 121⁰C for 15 minutes and label it accordingly.
• Wear appropriate Laboratory garments, gloves, and mask as required.
• Disinfect the outer surface of the sampling points with the help of 70% IPA.
• Discharge water for at least 2 minutes for the user points during the collection of sample and 1 minute for a storage tank in the water treatment plant.
• Collect water from each point at least 200 ml into the sterilized container for microbiology test.
• Collect the sample as soon as possible.
• Close the container after sampling and don’t expose the container for microbiology test.

Sample Preservation

• Samples shall be analyzed as soon as possible after being collected. If it is not possible to test the sample within about 3 hours of collection.
• The sample may be preserved at refrigerated temperatures (2-8⁰C) for maximum 12 hours to maintain the microbial attributes until analysis.

Test Schedule:

Perform the test as per the following schedule

Microbiological tests are as follows:

Potable/Pretreated Water

• Perform the test as per Analytical Method

Drinking water

• Perform the test as per QC Analytical Method

Purified Water

• Perform the test as per QC Analytical Method

Water for Injection

• Perform the test as per QC Analytical Method

Report preparation:

• Report of Potable/ Pretreated/ Drinking water Test Result in Annexure-I,
• Report of Purified Water Test Result in Annexure-II &
• Report of Water for Injection in Annexure-IV.

 Distribution of Water Test Result

• After completion of the analysis, inform the status of water test to a specific department.
• If any test result exceeds alert level or is out of specification, immediately inform to concerned department Head and engineering department also for corrective measurement.
• After taking corrective action, Engineering Department shall inform to Microbiology Section for further sample collection.
• Microbiology Section shall collect the sample from that area to carry out the analysis.
• After completion of the test, inform about the test result to concerned department after approval of Head Quality Assurance

Microbiological Analysis of water:

 Download All Annexure Here
Potable Water Test Report Annex I
Purified Water Test Report Annex II
Water Test Record (Log Book) Annex III
Water for Injection Test Report Annex IV