sop for sampling and testing of drain water


sop for sampling and testing of drain water


1.1 The objective of this SOP is to define the procedure for sampling (before sanitization and after sanitization) and testing of drain water.
2.1 This SOP is applicable for sampling for sampling (before sanitization and after sanitization) and testing of drain water and Microbiological Analysis
3.1 Microbiologist-Quality control- To follow the SOP sampling for sampling (before sanitization and after sanitization) and testing of drain water for Microbiological Analysis.
3.2 Head- Quality Control – Training on SOP.
3.3 Head- Quality Control- Implementation & follow up of SOP.
4.1 Head – Quality Control

5.1 In-House

6.1 As per procedure.

7.1 Collect approx 20 ml of drain sample (Before and after sanitization) in sterile container from
the drainage using sterile pipette.
7.2 Use sucking bulb and Pipette for collection of sample.
7.3 Testing Procedure for TOTAL VIABLE COUNT
7.4 Take 1 ml sample and dilute to 9 ml with sterile peptone water (1:10 dilution )
7.5 Take 1 ml from 1:10 dilution & further dilute to 9 ml with sterile sterile peptone water
7.6 (1:100 dilution). Similarly prepare 1:1000 dilution.
7.7 Finally take 1 ml sample solution from 1: 100 dilution or 1:1000 dilution with the help of
7.8 sterile micro Recent Updates
7.9 pipette in to sterile Petri dish aseptically for Bacteria and fungi count.
7.10 Perform the test in duplicate.
7.11 Pour approximately 20 ml of Sayabean Casein digest agar for bacteria and Sabouraud dextrose
7.12 Fungi previously melted and cool to 45 0c in to two different plates and mix well by tilting
rotating. Allow solidifying.
7.13 Write down the location No. and date an each plate.
7.14 Incubate the SCD agar plate at 30-35°C for bacteria for 3 days and Sabouraud dextrose agar
plate at 20-25°C for fungi for 5 days
7.15 After incubation period, examine the plate far growth . (No. of colonies)
7.16 Calculate the average colonies of two plates in terms of cfu/ml.
7.17 Count the No. of colonies as per following calculation and record in Annexure I
7.18 Calculation
7.18.1 1 : 100 a If the plate show N No. of cfu, the No. of cfu/ml = N x 100
7.18.2 1 : 1000 a If the plate show N No. of clu, the No. of = N x 1000
7.18.3 Pathogen Testing as per SOP and Record the results in
Annexure – I
7.19 Frequency: Once in a month.

SOP : Standard Operating Procedure
QAD : Quality Assurance Department
QCD : Quality Control Department
IPA : Isoproply alcohol
NA : Not Applicable
No. : Number


ANNEXURE NO. Title of Annexure Format No. of Annexure
ANNEXURE I Microbial Monitoring Of Drain Point
ANNEXURE II Sampling Plan For Drain Point


Name Of Sample   Drain No.    
Location   Media used SCDA Lot No.  
Incubation Condition SCDA at 30-35 For 3 days

SDA at 30-35 For 5 days

SDA Lot No  
Peptone water Lot No.  
Date of sampling Sample dilution Dilution Factor(F) Cfu/plate (P) Cfu/ml(FxP) Mean cfu/ml
Bacteria Fungi Bacteria Fungi Bacteria Fungi
Before Sanitization  


After Sanitization                  
Before Sanitization:                                                                      After Sanitization:

Bacteria                    cfu/ml                                                         Bacteria:            cfu/mlFungi :                       cfu/ml                                                         Fungi :               cfu/ml 
Acceptance Criteria for After Sanitization: NMT 1000 du/ml for Bacteria

                                                                          NMT 100 cfu/ml far Fungi



Analyst by




Checked by



Date   Date  



Pathogen testing      


Soyabean casein digest Medium Lot No. Date of inoculation


Name of Pathogen Name of media Media Lot No. limit Result
E.coli MacConkey Broth Absent /ml
MacConkey Agar
Salmonella RVSE Broth Absent /10ml
Xylose Lysine Deoxycholate Agar
Shigella GN Broth Absent /10ml
Xylose Lysine Deoxycholate Agar
P. aeruginosa, Cetrimide Agar Absent /ml
S. aureus, Mannitol- Salt Agar Absent /ml



Analyst by




Checked by



Date   Date  





S. No. Type of Water Sampling Point No. Location Frequency
1.         Drain Water DW-01 Media Preparation Room (Micro Lab)  

Once in a month

2.         Drain Water DW-02 Autoclave Room (Micro Lab)
3.         Drain Water DW-03 Discarding Room (Micro Lab)
4.         Drain Water DW-04 Chemical Room
5.         Drain Water DW-05 Production Autoclave Room
6.         Drain Water DW-06  
7.         Drain Water DW-07  
8.         Drain Water DW-08  
9.         Drain Water DW-09  
10.      Drain Water DW-10  
11.      Drain Water DW-11  
12.      Drain Water DW-12  
13.      Drain Water DW-13  
14.      Drain Water DW-14  
15.      Drain Water DW-15  

Frequency:- Once in a month




sop for calibration and validation of micro autoclave

sop for Sterility failure investigation

cleaning and operation of discard autoclave

sop for operation of fogger machine

sop for Biological assay of lactic acid bacillus

sop for preparation of culture inoculum

STP for sterility testing of sterile gloves

sop for Operation and calibration of active air sampler

sop for transfer of material for testing and sampling in sterile area

entry & exit procedure in microbiology laboratory

Growth Promotion Test In Microbiology Laboratory

Operation of B.O.D in Microbiology Laboratory

Operation of Horizontal Laminar Air Flow in the microbiology laboratory

Operation and cleaning of Pass Box.

Operation and cleaning of air sampler

Cleaning and Sterilization of Glassware

Analysis of water for microbial load in microbiology lab

Operation and temperature monitoring of Refrigerator

Fumigation of Microbiology Laboratory.

Entry & Exit procedure In Sterility Area

SOP for Microbial analysis of Raw Material Finished Products

SOP for Operation & Calibration of pH meter in Micro Department

SOP for Operation & Calibration of pH meter in Micro Department

SOP Operation and calibration of Hot Air Oven In Microbiology

SOP for operation cleaning & calibration of Digital colony counter

SOP for Operation And Cleaning of Microscope

sop for Media Preparation and Consumption

sop for Receipt Storage and Usage of Culture Media

sop for Cleaning Sanitization And Disinfection In Microbiology

sop for Environmental monitoring of all the Classified area

sop for Handling and Sub culturing of Microbial cultures

sop for Media Growth Promotion Test and various Microbiological test

sop for BOD incubator operation and cleaning

sop sampling of water for microbiological analysis

sop for Disinfectant Efficacy Test

sop for for cleaning and operation of vortex mixture

sop for Temperature & Relative Humidity Monitoring

sop for Operation and Calibration of Heating Block

sop for Sterility Testing of Microbiology

sop for Disposal of Culture Media

sop for Drain point of Microbiology

sop for entry & exit procedure In Microbial limit test and Biosafety

sop for Gram Staining of Bacteria in Microbiology Laboratory

sop for Monitoring of Compressed Air/gases for microbiological analysis

sop for BET (Bacterial Endotoxin) test in Microbiology

sop for receipt storage and Determining the population of Biological indicators

sop for qualification of analyst microbiologist

sop for Bioburden test of Packing materials in Microbiology Laboratory

sop for microbiological assay of erythromycin antibiotic

sop for liquid particle counter

sop for operation and calibration of digital zone reader

sop for monitoring of ultraviolet efficiency LAF and pass box

microbiological assay of cyanocobalamin or vitamin B12

gowning procedure for microbiological testing area

swab testing of various surfaces for bioburden determination

sop for endotoxin challenge test

Hold time study protocol for sterilized media

sop for personnel Qualification protocol for aseptic area

sop for sampling and testing of drain water

Sop for Operation of Airborne Particle Counter

sop for Inoculum Preparation

sop for Validation protocol of steam sterilizer autoclave

sop for pathogen detection from drain point

Sop for Analysis of Raw water Purified water water for injection and pure steam water

sop for preservatives efficacy test

sop for collection and preservation of in house isolated microorganisms

sop for Operation Calibration and Maintenance of Micropipette

Sop for UV Efficacy Test

sop for gram staining

Sop for swab testing

sop for microbiological testing of water


sop for depyrogenation of apparatus

sop for media preparation

sop for fertility test growth promotion test of media

sop for Operation and cleaning of moist heat sterilizer

sop for monitoring by active air sampler

sop for swab sampling and testing for clean rooms in production area

sop for monitoring in microbiology laboratory

sop for Fumigation of aseptic area and microbiology lab

sop for monitoring of personnel in aseptic area

sop for maintenance of cultures

sop for Operation and cleaning of laminar bench

preparation of settle plates

sop for monitoring of pure steam

sop for entry and exit procedure to m.l.t and b.e.t room

sop for storage of and use of media

sop for disposal of microbiological media and cleaning of microbiological glassware







Leave a Comment

error: Content is protected !!