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Water sampling procedure

1.0
PURPOSE
To lay down the procedure for sampling of water for Microbiological and Chemical analysis.
2.0
SCOPE
This is applicable to quality control department.
3.0
RESPONSIBILITY
Microbiology personnel
4.0
PROCEDURE
4.1
Sampling of water for Microbiological analysis
4.1.1
Before sampling ensure that the sampling kit is available as per the details mentioned in Annexure
III.
4.1.2
Refer Annexure IV for the sampling points for a particular day.

Note: The schedule shall be prepared before start of particular month.

4.1.3
Samples for microbiological evaluation should be collected in Pre-sterilized screw cap glass bottles.
4.1.4
For sampling of Treated Raw water (May contain chlorine), add 0.1 ml of 5 % Sodium Thiosulphate
solution in the bottles before sterilization.
Note: Before sampling, the aluminium foil covering the sampling point should be removed.
4.1.5
Wear the sterile hand gloves and remove the cap of the bottle just prior collecting the sample.
4.1.6
The "sample contact area of cap" should not come in contact with any surface, including the fingers
or hands of the individual collecting the sample.
4.1.7
The cap may be set on the top of a clean surface, topside against the surface.
4.1.8
Open the sampling/user point valve until there is a steady stream of water.
4.1.9
Drain for approximately 1 minute, collect water in sampling bottle.
4.1.10
Do not allow the bottle or the water in the bottle to come in contact with the valve.
4.1.11
Fill the bottle without overflowing the bottle.
4.1.12
Remove the bottle from the sample stream and place the cap on the bottle as quickly as

possible.

4.1.13
Tighten the cap securely.
4.1.14
Close the valve.
4.1.15
Fill the information on the face of the bottle such as location of sampling, date of sampling and
signature.
4.1.16
Collect all samples as per the Annexure-II and Proceed for analysis as per the SOP. If the samples
are not taken immediately for analysis store it at refrigerator (2-8C).
4.1.17
Ensure that analysis is initiated within 24 hrs after sampling.
4.2
Sampling of water for Bacterial Endotoxin Testing
4.2.1

Samples for bacterial endotoxin test should be collected in depyrogenated vials covered with
aluminum foil.
4.2.2
Remove the aluminum foil from the vial immediately prior to collecting the sample.
4.2.3
The "sample contact area of aluminium foil" should not come in contact with any surface, including
the fingers or hands of the individual collecting the sample.
4.2.4
The foil may be set on the top of a clean surface, topside against the surface.
4.2.5
Open the sampling/user point valve until there is a steady stream of water.
4.2.6
Drain for approximately 1 minute, collect water in sampling vial.
4.2.7
Do not allow the vial or the water in the vial to come in contact with the valve.
4.2.8
Fill the vial, without overflowing the vial.
4.2.9
Remove the vial from the sample stream and place the aluminium foil on the vial as quickly as
possible.
4.2.10
Cover the vial with aluminium foil after sampling.
4.2.11
Close the valve.
4.2.12
Fill the information on the face of the bottle such as location of sampling, date of sampling and
signature.
4.2.13
Collect all samples as per the Annexure-II and Proceed for analysis as per the SOP. If the samples
are not taken immediately for analysis store it at refrigerator (2-8C).
4.2.14
Ensure that analysis is initiated within 24 hrs after sampling.
4.3
Sampling of water for Chemical analysis
4.3.1
Samples for chemical analysis should be collected in a clean and dried bottle.
4.3.2
Remove the cap from the bottle just prior to collect the sample.
4.3.3
The sample side of the cap should not come in contact with any surface, including the finger or
hands of the individual obtaining the sample.

4.3.4
The cap may be kept on the top of a clean surface, topside against the surface.
4.3.5
Open the sampling/user point valve until there is a steady stream of water.
4.3.6
Drain for approximately 1 minute, Collect water in sampling bottle.
4.3.7
Rinse the bottle with the water to be sampled at least three times.
4.3.8
Do not allow the bottle or the water in the bottle to come in contact with the valve.
4.3.9
Fill the bottle and remove the bottle from the sample stream and place the cap on the bottle as
quickly as possible and ensure that no air bubble is entrapped.
4.3.10
For TOC analysis collect the sample in the separate vials/bottles. Collect the sample by over flowing
the vials and close with the lid/cap immediately.
4.3.11
Close the valve.
4.3.12
Fill the information on the face of the bottle such as location of sampling, date of sampling and
signature.
4.3.13
Collect all samples as per the Annexure-II and Proceed for analysis as per the SOP. If the samples
are not taken immediately for analysis store it at refrigerator (2-8C).
4.3.14
Ensure that the analysis is in any case is initiated within 24 hrs after sampling.
4.4
Shipment
4.4.1
If a contract laboratory is utilized, samples shall be sent by express service to arrive at the contract
laboratory.
4.4.2
Sample container transfer "boxes" should include provisions for maintaining the sample temperature
below 25C at any time.
4.4.3
Samples should not be frozen or cooled to a temperature < 2C.
4.5
Numbering of test data sheet.
Where,
4.5.1
Number the test data sheet according to YXXNNNN

Y = Last digit of current year.

XX = Code number of water type
such as (Raw water-RW, Soft water-SW, Potable water -DW, Drinking water-DR,

RO water-RO,

Purified water-PW, Water for injection-WF, Pure steam-PS).

NNNN = Serial No. starting from 0001.
4.5.2
Allot the test data sheet number in Annexure-I in remark column.
4.6
Document numbering of test data sheet
Where,
4.6.1
Document numbering of test data sheet is as follow TDS/XX/00N
TDS = Test data sheet
XX = Code number of water type
such as (Raw water-RW, Soft water-SW, Potable water-DW, Drinking Water-DR, RO water-RO,
Purified water-PW, Water for injection-WF, Pure steam-PS).
NNN = Serial No. starting from 001.
5.0
ABBREVIATIONS AND DEFINITIONS
SOP

Standard Operating Procedure

QCM

Quality Control Microbiology

QAD

Quality Assurance Department

REV.

Revision

No.

Number

Percent

mL

Milli litre

Degree Centigrade

hrs

Hours

TOC

Total Organic Carbon

RW

Raw Water

SW

Soft Water

DW

Potable water

DR

Drinking water

PW

Purified Water

WF

Water for Injection

PS

Pure steam
TDS

Test Data Sheet

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SOP for Identification of microbial cultures using biomeriux identification system

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SOP for Operation of Rady Count Down Timer

SOP for Personnel Qualification of personnel entering into Aseptic area and
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SOP for Post Sterility Growth Promotion Test

SOP for Preparation of Trends

SOP for Procedure For Bioburden, BET, And LPC Of Primary Packaging Materials

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SOP for Procedure for Handling of Out Of Limit Results in Environmental

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SOP for Procedure for Operation of Deduster Cum Metal Detector

SOP for Procedure for Receipt of Raw and Packing Material

SOP for Procedure for Storage and Preparation of Microbiological Culture Media

SOP for Procedure for preparation of dresses for sterilization.

SOP for Sampling and Testing of Pure Steam

SOP for Sterility Testing Using Manifold For Dilution Study and Stability

SOP for Swab sampling for validation of test surface to evaluate cleaning efficacy.

SOP for Testing of Particulate Matter in Injections and Operation and Maintenance
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SOP for a procedure for preparation of the volumetric solutions

SOP for allocating identification number to instrument/ equipment

SOP for bacteriological incubator

SOP for calibration Total Organic Carbon (TOC) Analyser

SOP for calibration of HPLC column oven

SOP for calibration of pH meter temperature sensor

SOP for calibration of Autotitrator

SOP for calibration of Gas chromatograph

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SOP for calibration of Polarimeter

SOP for calibration of autotitrator

SOP for calibration of balance

SOP for calibration of conductivity TDS meter

SOP for calibration of disintegration test apparatus

SOP for calibration of hardness tester

SOP for calibration of infrared moisture balance

SOP for calibration of karl fischer apparatus

SOP for calibration of plunger operated pipette

SOP for calibration of refractometer

SOP for calibration of the refractometer

SOP for calibration of walk-in- incubators 20-25c and 30-35c

SOP for calibration procedure of u.v.cabinet

SOP for careful handling of poisonous chemicals

SOP for check suitability of dissolution test apparatus

SOP for cleaning and disinfection

SOP for cleaning and operation of RLAF unit in Sampling Room

SOP for cleaning and operation of incubator

SOP for cleaning for DHS

SOP for cleaning of Dispensing & Sampling Room

SOP for cleaning of Metrohm Karl fisher

SOP for cleaning of Vertical Autoclave

SOP for cleaning of automatic distillation apparatus

SOP for cleaning of colony counter

SOP for cleaning of disintegration test apparatus

SOP for cleaning of dissolution tester

SOP for cleaning of friability test apparatus

SOP for cleaning of melting point apparatus

SOP for cleaning of oven for incubator at 55c

SOP for cleaning of slit to agar air sampler

SOP for cleaning of tablet hardness tester

SOP for cleaning procedure for Alu-Alu Packing Machine

SOP for cleaning procedure for Automatic Coating System

SOP for cleaning procedure for Blister Packing Machine

SOP for cleaning procedure for Colloidal Mill

SOP for cleaning procedure for Deblistering machine

SOP for cleaning procedure for Dehumidifier

SOP for cleaning procedure for EPD Collator machine with strip packing machine
line

SOP for cleaning procedure for FBD Bag

SOP for cleaning procedure for Hose Pipe Of Dust Extraction System

SOP for cleaning procedure for Mini roll compactor

SOP for cleaning procedure for Paste Kettle

SOP for cleaning procedure for Rapid Mixer Granulator (R.M.G.)

SOP for cleaning procedure for Semi-Automatic Cartoning Machine

SOP for cleaning procedure for Strip Packing Machine

SOP for cleaning procedure for Vacuum Cleaner

SOP for cleaning procedure for brooke field viscometer

SOP for cleaning procedure for capsule filling cubicle

SOP for cleaning procedure for centrifuge

SOP for cleaning procedure for dissolution test apparatus

SOP for cleaning procedure for heating block

SOP for cleaning procedure for microbiological laboratory other than clean area.

SOP for cleaning procedure for multi mill

SOP for cleaning procedure for polarimeter

SOP for cleaning procedure for semi auto induction cap sealing machine

SOP for cleaning procedure for u.v. /visible spectrophotometer

SOP for cleaning procedure for ultrasonic bath

SOP for cleaning procedure for water bath

SOP for cleaning procedure for zone reader

SOP for cleaning procedure of balances

SOP for cleaning procedure of deep freezer

SOP for cleaning procedure of puncture resistance tester

SOP for cleaning procedure of sterile dress cabinate

SOP for collection and storage of retained samples of packaging material

SOP for control of master data generation by computer system

SOP for destruction of control samples (Raw material and Finished product)

SOP for dispensing and issuing of Packing Material as per the requirement from
Production Department

SOP for disposal of expired chemicals, reagents, solvents and micro-biological

medium.

SOP for disposal procedure for media containing growth

SOP for environmental monitoring of dispensing and sampling area in raw

materials

SOP for environmental monitoring of solid dosage form area by non viable air
particle count

SOP for evaluation of environmental monitoring results (trend analysis)

SOP for for measurement of particle size of raw materials using microscopic
method

SOP for general test procedure

SOP for gowning procedure for the visitors

SOP for guideline for storage condition of raw material

SOP for hand wash procedure

SOP for handling and control for the prohibited items

SOP for handling and testing of various samples

SOP for handling of glassware

SOP for handling of spillage of solid/liquid media containing growth

SOP for heat distribution study in chamber of depyrogemation oven using

different probe with data logger

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SOP for hplc column receipt checking and regeneration

SOP for identification of organisms

SOP for inventory and issuances of media in quality control lab

SOP for investigation of sterility test failure

SOP for laboratory safety

SOP for laminar air flow workstation

SOP for logic for giving number to the method for analysis of finished product and
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SOP for maintenance & cleaning procedure for sampling equipment

SOP for maintenance of desiccator

SOP for media disposal

SOP for method for programme file checks of software of instruments

SOP for microbial limit test for raw materials and finished products

SOP for microbial testing of drain water

SOP for microbiological monitoring of clean equipment in to solid dosage area.

swab method

SOP for muffel furnace

SOP for operating procedure of Dehumidifier

SOP for operating procedure of culture cabinet

SOP for operating procedure of double door autoclave

SOP for operating procedure of laminar air flow

SOP for operation and calbration of dry bath

SOP for operation and calibration of bursting strength tester

SOP for operation and calibration of pH meter (GMPH)

SOP for operation and calibration of tablet disintegration apparatus

SOP for operation and cleaning of LAF unit in Sampling Room

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SOP for physical monitoring of microbiology section

SOP for preparation and handling of primary standard

SOP for preparation of bench reagents

SOP for preparation of sterile petridishes, agar slants and agar butts

SOP for procedure environmental monitoring of parenteral processing area : by

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SOP for procedure for DOP testing (Integrity Testing) of HEPA filter

SOP for procedure for Operation and cleaning of Automatic Batch Printing Machine

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SOP for procedure for Operation of Batch Printing Machine (Semi Automatic)

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SOP for procedure for Operation of Drum mixer

SOP for procedure for Operation of Multimill

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SOP for procedure for Operation of Stirrer

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SOP for procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies &
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SOP for procedure for Pre Filter cleaning of RLAF

SOP for procedure for Receipt, Issuance, Storage and Handling of solvent

SOP for procedure for Tablet granulation, compression and coating

SOP for procedure for action to be taken during spillage/breakage of materials

SOP for procedure for analyst validation

SOP for procedure for calibration of instruments

SOP for procedure for carrying out air borne particle count in static condition

SOP for procedure for cleaning and maintenance of boilers

SOP for procedure for cleaning installation, operational and performance

qualification of equipment / instruments.

SOP for procedure for cleaning of barrel pump & pipe

SOP for procedure for cleaning of clean area

SOP for procedure for cleaning of equipment and accessories in Production Area

SOP for procedure for cleaning of microbiological glassware

SOP for procedure for collection and storage of control sample

SOP for procedure for cooling towers

SOP for procedure for destruction of rejected materials

SOP for procedure for electrical safety

SOP for procedure for entering in sterility testing room

SOP for procedure for environmental monitoring of aspetic area: finger prints and
gown sampling

SOP for procedure for environmental monitoring of parenteral processing area :

surface testing by means of rodac plate and swab

SOP for procedure for fumigation in microbiology lab

SOP for procedure for handling of Rejected Raw Material

SOP for procedure for handling of sieves and screen

SOP for procedure for inspection of pressure vessels, lifts and chain pulley blocks

SOP for procedure for issuance of additional packaging materials

SOP for procedure for maintaining and up-keeping the facility

SOP for procedure for making production related entries in SAP system

SOP for procedure for measurement of air velocity and calculation of air changes
per hour for classified areas

SOP for procedure for operating and cleaning of Vacuum Cleaner

SOP for procedure for operation after M.S.E.B. power failure

SOP for procedure for operation and calibration of precision oven

SOP for procedure for operation and maintenance of low tension (L. T.) panels

SOP for procedure for operation of EPD Collator coupled with strip packing
machine

SOP for procedure for operation of axial flow fan units (supply and return)

SOP for procedure for operation of conveyor belt in packing

SOP for procedure for operation of high tension (H.T.) panel

SOP for procedure for operation of semi auto induction cap sealing machine

SOP for procedure for operation of the domestic hot water system

SOP for procedure for overprinting of batch details on cartons and catch covers

SOP for procedure for performance of automatic distillation apparatus

SOP for procedure for preparation of reagent solution

SOP for procedure for preparation of working standards

SOP for procedure for proper disposal of expired finished goods

SOP for procedure for reanalysis of raw material

SOP for procedure for recleaning

SOP for procedure for recording of Temperature & Humidity in Stores Department

SOP for procedure for recording of Temperature in Production Department

SOP for procedure for return of Raw & Packing materials from production
department

SOP for procedure for safe unloading of chemicals, furnace oil and high-speed
diesel from vehicle inside the factory premises

SOP for procedure for sampling and testing schedule of water for injection and
clean steam

SOP for procedure for sanitization of purified water generation system using hot
water

SOP for procedure for stability studies of finished goods

SOP for procedure for stenciling of shippers used for packing

SOP for procedure for storage & transference of dispensed raw material in day
store

SOP for procedure for temperature mapping

SOP for procedure for testing and release/rejection of packing materials

SOP for procedure for the Blister Pack Machine

SOP for procedure for the intimation of break down of utilities services &
equipments in manufacturing & packing department during working

SOP for procedure for the operation of Semi-Automatic Cartoning Machine (VP120)

SOP for procedure for the passivation of purified water storage tank and
distribution piping

SOP for procedure for transfer of the finished goods to bonded store room

SOP for procedure for validation of microbiologist

SOP for procedure for vessels operated greater than atmospheric pressure

SOP for procedure of fumigation in production area by using 5 % Gramicid and

Fogger

SOP for procedure to specify the responsibilities of production department

SOP for quantification of culture

SOP for receipt and maintenance of working standards of API

SOP for release of finished product

SOP for retesting schedule of packaging material

SOP for retesting schedule of raw material (for API)

SOP for routine cleaning verifictaion by TOC-SSM method

SOP for sampling and release of Inprocess samples

SOP for sampling and testing schedule of purified water

SOP for sampling of packing material

SOP for selection criteria and its procedure before dissolution profile study

SOP for statistical study for trend analysis of purified water and water for
injection

SOP for sterile dress cabinet

SOP for storage and use of reagents & chemicals

SOP for testing for bioburden of fractional solutions

SOP for testing of miscellaneous sample

SOP for training procedure for qc persons

SOP for ultrasonic cleaner

SOP for validation of DHS with biological indicator

SOP for validation of autoclave with biological-indicator

SOP for validation of oven for depyrogeneation.

SOP for verification of system suitability test measured by chrom card software
for GC

SOP for writing method of analysis for P.M

SOP procedure for preparation and Bioburden monitoring of IPA 70% V/V

WHO SOP list for Pharma Microbiology

WHO SOP list for Pharma Quality Assurance

WHO SOP list for Pharma Quality Control Cleaning

Water sampling procedure

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