SOP for Sampling and Testing Schedule of Purified Water : Pharmaceutical Guidelines

SOP for Sampling and Testing Schedule of Purified Water

Standard operating procedure for schedule & frequency for testing, locations for sampling and type of analysis required to be carried out for the Purified water for monitoring & assurance of its quality.

1.0 OBJECTIVE

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

2.0 SCOPE

This Procedure is applicable during sampling and analysis of purified water.

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 a Purified water 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 Purified water in b the ttle
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 Purified water sample for Total Organic Carbon (TOC) test.
5.2.1 Use airtight container for collection of Purified water 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 Collect the samples of purified water and test accordingly as per Annexure.
5.3.1 Use suitable container for collection of Purified water 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 30min.
5.3.2 Discard the PW filled in sterilized sample container just before collection of purified water sample for analysis.
5.3.3 Collect about 15 ml of purified water sample in sterilized container and close tightly.
5.4 Collection of purified water sample for Bacterial Endotoxin Test (BET)
5.4.1 Use Depyrogenated glass container for collection of purified water sample.
5.4.2 Collect about 15ml purified water sample for BET.
Remark: (1) Send the sample within 1hr. to microbiology Lab for BET & Microbiological test.
(2) After sampling it is recommended that, the water sample is keep at 2-8 °C.
If analysis cannot be performed within 8 hours after sampling, the sample must be kept at 2-8°C.
The microbiological testing of a sample must be performed no later than 24 hours after sampling and within the time limit test should be started.

5.5 Purified water frequency of testing
Location Test to be carried out Frequency
UF Outlet Chemical test, pH, Conductivity, TVC, TOC. Daily
User End Point Total viable count, pH, Conductivity, TOC Once in a week
Note: Complete analysis: As per specification

6.0 ABBREVIATIONS

°C = Degree centigrade
TVC = Total viable count
TOC = Total organic carbon
Q.C = Quality control department





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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1 comment: Post Yours! Read Comment Policy ▼

  1. Would you please inform me, the reference of flush time (30 seconds, though i knew it 2 to 3 minutes) before sampling that you mentioned in 5.1.2 sub part.?

    ReplyDelete


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