1.0 PURPOSE 1.1 2.0 SCOPE 2.1 3.0 To lay down the procedure for sampling of water for chemical and microbiological Analysis This SOP covers the sampling procedure for potable water and purified water RESPONSIBILITY 3.1 4.0 ACCOUNTABILITY 4.1 5.0 Microbiologist / QC Chemist Deputy Manager-QC PROCEDURE 5.1 CHEMICAL ANALYSIS Microbiologist / QC Chemist shall collect samples Samples shall be collected as per the sampling plan and frequency as per Schedule. 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.1.6 Use Clean 500 ml and 250 ml glass bottles having stopper for chemical analysis for Potable and Purified water respectively. Label the bottle in Format No.: xxxxx and Rinse with purified water. Collect about 500 ml of Potable water in the pre rinsed bottles and 250 ml of purified water from respective sampling points. Stopper the bottle tightly and bring it to the lab for analysis. Enter the details like sampled by, Quantity, Date of sampling, sampling point name and number as per xxxxx and carry out analysis as per current version of specification. After completion of analysis (If it passes) inform to production block incharge to write the A.R.Number daily report. 5.2 PREPARATION OF 70% IPA 5.2.1 5.3 Prepare 70% IPA as per current revision as per SOP No xxxxx MICROBIOLOGY ANALYSIS 5.3.1 Clean 250ml autoclavable, screw-capped, glass bottles and rinse with purified water. 5.3.2 Add 0.1 ml of a 5% Sodium Thiosulphate and 0.1 ml of 15% EDTA solution in the bottles (For potable water sampling). 5.3.3 Close the bottle with cap and wrap the neck securely with aluminum foil using rubber bands. Sterilize then at 15-psi pressure, temp 121°C for 20 minutes. Follow the procedure for collection of water sample for microbiology as given below. 5.3.4 5.3.5 5.3.6 5.3.7 5.3.8 Collect the water from each sampling point as per schedule. Label the bottle stating the Name and number of the collection point and date of sampling as per xxxxx Before collection, wipe the tap/valve with cotton soaked in 70% Isopropyl Alcohol. Open the tap/valve and allow the water to run for three minutes. 5.3.9 Hold the sterile bottle near the sampling point and unwrap the aluminum foil and open the bottle, take care not to touch the inner surface of cap or the neck of the bottle to any other non-sterile part. 5.3.10 Collect the water in the bottle, and immediately close it with the cap. Do not fill the bottle up to the neck. 5.3.11 Close the tap/valve. 5.3.12 Wrap the neck of the bottle with aluminum foil, securing with rubber bands to avoid contamination during transportation. 5.3.13 Bring the sample to laboratory and enter the details in register 5.3.14 Carry out the analysis with in 2 hours after collection of samples or store in the refrigerator at 2-8 °C. 5.3.15 Before analysis allow the Refrigerated samples to room temperature and perform the test with in 24 hours. Keep sampling bottles closed until it is to be sampled. The Microbiologist shall do the sampling. Care should be taken while collecting the samples that the collection process will be representative of water being tested. Keep air space in the bottle (at least 2.5cms) to facilitate mixing by shaking before examination END OF DOCUMENT