To lay down the procedure for sampling, testing and release of potable water and purified water.
1.0 Purpose :
To lay down the procedure for sampling, testing and release of potable water and purified water.
2.0Scope:
This procedure applicable to be followed during sampling, testing and release of potable water and purified water.
3.0Responsibility:
The responsibility of sampling and testing of potable water and purified water lies with the Quality Control analyst and release of potable water and purified water lies with QCD-In charge or his designate.
4.0Definitions/Abbreviations:
TOC : Total Organic Carbon
5.0 Procedure :
5.1 Procedure for sampling of Water :
5.1.1 Sampling Procedure for Microbiological Analysis:
5.1.1.1 Sterilize suitable bottles containing 10 – 50 ml water (100/200/250/500 mL capacity bottles) at 121°C/1.2Kg/cm2 (15lbs) for 30 minutes in an autoclave.
5.1.1.2Sterilized sample bottles shall not be opened till the time of collection of water sample.
5.1.1.3 Sanitize the SS Can by using prepared 70%v/v Isopropyl alcohol (IPA) and allow the IPA to evaporate completely. Keep sterilized sample bottles in SS can and carry to sampling points.
5.1.1.4 QCD analyst shall wear suitable personnel protective equipment (PPE) and sanitized gloves during water sampling.
5.1.1.5 Sanitize the water outlet of the sampling points and hose pipe connected to the user points by spraying with 70% v/v IPA and allow the IPA to evaporate completely.
5.1.1.6 Flush out about 5-10 Liters of water before collection. Rinse the sample bottle and collect water sample up to the neck of the bottle.
5.1.1.7 Close the bottles immediately after collection of water sample and affix the sample label on bottles as per format.
5.1.1.8 Collected samples shall be analyzed within 2 hours, if it is not possible to analyse within 2 hours, store samples in refrigerator at 2-8°C for maximum of 12 hours after collection of samples, analyse as per relevant STP and report the results.
5.1.2 Sampling Procedure for Chemical Analysis:
5.1.2.1 Take 500mL of clean sample bottle previously dried at 105°C for 1 hour.
5.1.2.2 Separate bottle shall be used for collection of each sample from sampling points.
5.1.2.3 Open the sampling point valve, flush out about 5-10 Liters of water and rinse the sample Bottle twice. Collect the sample and close the lid immediately.
5.1.2.4Close the sampling point valve and affix the sample label on bottles as per form.
5.1.3 Sampling Procedure for TOC Analysis:
5.1.3.1 Clean 500 mL sample bottle with 1N Nitric acid and finally with milli Q water. Dry the sampling bottles in an oven at 105°C for 2 hours by wrapping the mouth of the bottles with aluminium foil.
5.1.3.2Aluminium foil should not be opened till the time of collection of water sample.
5.1.3.3Flush out about 5–10 Liters of water before collection. Rinse the sample bottle and collect the sample till the bottle over flows. After collection of water sample close the bottle
with cap. Affix the sample label on the bottle as per form.
5.1.3.4 Separate bottles shall be used for collection of each sample from sampling points.
5.1.3.5 TOC analysis shall be done daily. Incase of instrument break down for more than one day sample shall be tested at other Mylan location or approved public testing lab.
5.1.4 Testing and frequency:
5.1.4.1Microbial and chemical testing:
Microbial and chemical testing shall be carried out with respective STP’s of Purifiedwater and Potable water.
5.1.4.2R2A agar media for “Total aerobic microbial count” and Soyabean casein digest broth for “Test for pathogens” shall be prepared 12-24 hours before analysis and incubate the media at 30-35°C for 12-24 hours.
5.1.4.3 Sampling points: Purified water storage tank, After UV , and Return loop shall be done thrice in a week for Total Aerobic Microbial Count. Identification of Pathogen test shall be done weekly once for Return loop.Chemical analysis of Return loop shall be carried out daily. Heavy metals test shall be carried out once in a week for Return loop.
5.1.4.4User points (MB-I & II): User point shall be monitored monthly once such that each point Shall be covered once in a month for Total Aerobic Microbial Count.
5.1.4.5 Sampling point (MB-III): Sampling points at MB-III distribution loop system shall be Storage tank, after UV and Return loop are done thrice in a week for Total Aerobic Microbial Count. Identification of pathogen test shall be done weekly once for Return loop. Chemical analysis of Return loop shall be carried out daily. Heavy metals test shall be carried out once in a week for Return loop.
5.1.4.6 User Point (MB-III): User points at MB-III shall be monitored monthly once such that each point shall be covered once in a month for Total Aerobic Microbial Count.
5.1.4.7 Monthly schedule for purified water shall be prepared as per form(Water sampling plan) in (Water sampling schedule for microbiology test) based on approved water sampling plan.
5.1.4.8 Potable water sampling point: Microbial analysis of potable water shall be done once in 15 days for Total Aerobic Microbial Count and Identification of pathogens. Chemical analysis of potable water shall be done daily. Drinking water (Canteen water) shall be done monthly once for Total Aerobic Microbial Count and Identification of pathogens.
5.1.4.9 List of water sampling plan are prepared yearly once / when there is modifications in points in form per Annexure-1.
5.1.5 Potable water pesticide residues analysis: Analysis for presence of pesticide residues shall be done once in a year by external agency as per USP.
5.1.6 Potable water complete analysis: Complete analysis shall be done once in a year by external agency as per WHO.
5.2 Procedure for clearance and release of water:
5.2.1 Enter the samples in Purified water / potable water Inward register as shown in form register in LIMS. The collected water samples shall be analyzed as per individual STP’s of Purified water and Potable water by QCD-Microbiologist/Analyst.
5.2.2 The approved purified water and potable water shall be reported individually with respective type of water in AR-report of ‘Analytical Report’ as shown in
5.2.3 File the approved AR-reports in respective departments and send the copy of each report to water Plant maintenance personnel for their corrective action.
5.2.4 Acceptance criteria:
i)Total Aerobic microbial count:
Alert limit : 40 CFU/ml
Action limit : 70 CFU/ml
Standard limit : 100 CFU/ml
ii) TOC:
Alert limit : 220 ppb
Action limit : 360 ppb
Standard limit : 500 ppb
6.0 Related Documents : Nil
Sampling, testing, microbiology, potable water, purified water
