SAMPLING, REGISTRATION AND TESTING OF PURIFIED WATER FOR CHEMICAL AND MICROBIOLOGICAL TESTS

• PROCEDURE FOR THE SAMPLING, REGISTRATION AND TESTING OF PURIFIED WATER FOR CHEMICAL AND MICROBIOLOGICAL TESTS:
• Purified water is essential in a pharmaceutical plant, used in various stages of manufacturing, from cleaning equipment to formulating medications. To ensure its quality and safety, regular sampling and testing are crucial.

• Operating Procedure: Sampling and Testing Plan:
• Chemical and microbiological testing shall be done for purified water at various stages of water generation and distribution.
• Follow Format -I for water sampling schedule and prepare a monthly sampling and testing schedule by using the Format-II.

• Glassware preparation for chemical and microbiological sample collection:
• Glassware used for purified water sampling shall be rinsed with purified water and dried in an oven at 55°C-60°C.
• Collect 400 ml sample in 500 ml capacity Glass bottles shall be used for chemical analysis.
• Connect the TOC pipe to the Sampling or User point and operate the TOC analyzer as per SOP.
• Collect 100 ml sample in Sterilized glass bottles of 100 ml capacity shall be used for Microbiological analysis.
• For identification of Microbiology sampling bottles, affix the Chemical indicator tape prior to sterilization and sterilize as per validated sterilization cycle.
• For chlorine treated water samples add 0.5 ml of 5% w/v sodium thiosulphate solution in to the bottle before sterilization.
• SS sampling kit shall be sanitized with 70 % v/v IPA.
• Carry the pretreated and pre-sterilized sampling bottles, hand gloves and nose mask in a SS sampling kit to the respective locations to collect the purified water sample for chemical and microbiological testing.

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• Procedure for sampling of purified water (chemical and microbiology):
• Prior to sampling, label the pretreated sampling bottle for chemical testing and pre sterilized bottle for Microbiological testing with details of Sampling point number, sampled by sign, date and time.
• Samples shall be collected as per specified sampling and testing Schedule.
•  Sampling point’s schematic diagram.
• Open the valve completely and allow draining the purified water for 2-3 minutes and slightly closing the valve sufficient for sampling.

• Rinse the sampling bottles for 2 to 3 times with purified water to be collected from the sampling point.
• Collect 500 ml sample (Chemical and microbial in separate containers) for analysis as per USP/Ph. Eur specification.
• Immediately tighten the bottle with screw cap.
• While collecting the microbiological samples, wear the hand gloves and nose mask.
• Disinfect the glove hands with the 70% IPA.
• Sanitize the sampling point with 70% IPA.
• Fill the pre-sterilized bottle without rinsing. Keep the sufficient air space in bottle and immediately close the bottle.
• Wherever the user points have hose pipe, collect the sample from the end of the hose pipe.
• Collect the sample of 100 ml with minimal headspace and close the bottle tightly.
• Affix the sampling status label to the sampled bottles immediately and update water sampling status label. 

Note: Sterilized glassware shall only be used for microbiological sampling.

• REGISTRATION OF SAMPLES:

• Purified water samples shall be registered as per SOP.

• Section in charge shall approve the samples, senior executive /Group leader shall in turn delegate individual tests to concerned analyst.
• After delegation the analyst shall take worksheets.
• Analyst shall perform the tests as per approved analytical testing procedures.

• After completion of analysis analyst shall enter the test results in worksheet.

• Completed worksheet shall be handed over to Group leader/Designee.
• Group leader/Designee shall review and approve the delegated tests after checking the work sheet and final approval shall be given by section in charge / Designee.
• All the samples A.R. No shall be generated in water samples inward register as per Format-III. The A.R. No. Shall have a unique numbering system. Batch / Lot No. Shall be given as “QCPW/DDMMYY” signifying the day of sampling.

• A.R. No. shall comprise of Twelve characters as shown below E.g.: QCPW2500001 is the first sample for

• First Two characters “QC” for department quality control
• Next Two characters “PW” indicates Purified water
• Next two characters “25” represents the year 2025
•  Last five characters “00001” represents sequential number for each sample.
• Note: Batch / Lot No. Shall be given as “QCRW/DDMMYY” signifying the day of sampling For Raw water. RW indicates Raw water

• For validation of purified water samples A.R. No. Shall be given as QCVW2500001.

• First Two characters “QC” for department quality control
• Next Two characters “VW” indicates Validation purified water sample
• Next two characters “25” represents the year 2025
• Last five characters “00001” represents sequential number for each Sample.

• The manual Batch / Lot No. shall be referred to in the production batch records.
• TESTING:
• Chemical and microbiological samples:
• Analyze the samples within 2 hour after sample collection.

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• In case of any delay in analysis, store the samples at 2-8°C and analyze the samples within 12 hours in case of any delay in analysis after 12 hours discard the samples and collect fresh samples for analysis.
• If stored at 2-8°C, allow the samples to attain the ambient temperature before analysis.
• Samples collected from different user points as per sampling schedule shall be analyzed for chemical and microbiological test parameters.
• Analyze the Chemical samples (Raw water and Purified water) as per specification.
• Analyze the microbiological samples as per SOP.
• Samples for TOC shall be analysed using TOC Instrument as per SOP

Note: On unscheduled breakdowns and holidays, samples from the stipulated sampling points shall not be collected for the week.

• The PU Tube (PU tube is using for purified water online TOC analysis) shall be replaced at a frequency of once in 3 months and record the details in Format -V.
• RELEASE OF SAMPLES:

Chemical and microbiological Samples:

• Partial COA shall be generated based on chemical test parameter results for the samples of storage tank.
• Water release shall be as per partial COA for Sampling Points of storage tanks.
• COA shall be sent to the Production department and Maintenance department. Maintain the QC Copy along with work sheet.
• Affix an approved label on the purified water storage tanks.
• Enter the chemical test results in work sheet on the same day.

• Enter the microbiological test results in work sheet after completion of specified incubation period.
• After approval, full COA as per specification shall be attached to the work sheet.
• Interpretation of Alert and Action limits and action recommended:

Chemical and Microbiological test parameters:

• If any test result exceeds the Alert limit, alert the Quality assurance department and Maintenance department.
• Alert limit 25 cfu /mL and Action limit will be 50 cfu /mL. If any test result exceeds the Action limit, immediately inform the Quality assurance and Production Department for further necessary corrective Action.
• If any test result exceeds specification limit, Inform to Quality Assurance, Maintenance and Production department to stop usage of purified water from the respective point.
• Quarantine the products manufactured during the period.
• Products shall be subjected to Microbiological testing and release the products if they meets the requirement.Investigation shall be done as per SOP.
• PREPARATION OF TRENDS:

Chemical and Microbiological test parameters:

• Monthly trends shall be prepared for all sampling points.
• Prepare the trends for test parameters pH, TOC, Conductivity and TMC.
• Submit the trends monthly to Quality assurance Department for further review.

• ANNEXURES: 

ANNEXURE NO.	TITLE OF ANNEXURE
Annexure-I	Purified water system sampling and testing schedule
Annexure-II	Monthly water sampling schedule template
Annexure-III	Water Samples Inward Register
Annexure-IV	Water sampling status label.
Annexure-V	PU Tube replacement record.

• ABBREVIATIONS:

No.	:	Number
cfu	:	Colony Forming Uni
TOC	:	Total Organic Carbon
OOS	:	Out Of Specification
COA	:	Certificate of Analysis
TMC	:	Total Microbial Count
SS	:	Stainless steel
A R No.	:	Analytical Report Number
SOP	:	Standard Operating Procedure
QC	:	Quality Control

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Annexure-I
PURIFIED WATER SYSTEM SAMPLING AND TESTING SCHEDULE

Annexure-II
Monthly water sampling schedule template

Annexure-III
WATER SAMPLE INWARD REGISTER

Annexure-IV
WATER SAMPLING STATUS LABEL

Annexure-V
PU TUBE REPLACEMENT RECORD

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