sop for sampling and testing of drain water
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for sampling (before sanitization and after sanitization) and testing of drain water.
2.0 SCOPE
2.1 This SOP is applicable for sampling for sampling (before sanitization and after sanitization) and testing of drain water and Microbiological Analysis
3.0 RESPONSIBILITY
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.
4.0 ACCOUNTABILITY
4.1 Head – Quality Control
5.0 REFERENCE(S)
5.1 In-House
6.0 ENVIRONMENT, HEALTH AND SAFETY
6.1 As per procedure.
7.0 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.
8.0 ABBREVIATIONS
SOP : Standard Operating Procedure
QAD : Quality Assurance Department
QCD : Quality Control Department
IPA : Isoproply alcohol
NA : Not Applicable
No. : Number
9.0 ANNEXURE
ANNEXURE NO. | Title of Annexure | Format No. of Annexure |
ANNEXURE I | Microbial Monitoring Of Drain Point | |
ANNEXURE II | Sampling Plan For Drain Point |
ANNEXURE I
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
|
||||||||||||||||||
|
Pathogen testing
|
ANNEXURE II
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
|
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sop for for cleaning and operation of vortex mixture
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sop for Disposal of Culture Media
sop for Drain point of Microbiology
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sop for Monitoring of Compressed Air/gases for microbiological analysis
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sop for receipt storage and Determining the population of Biological indicators
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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 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 microbiological testing of water
sop for depyrogenation of apparatus
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
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sop for Fumigation of aseptic area and microbiology lab
sop for monitoring of personnel in aseptic area
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sop for Operation and cleaning of laminar bench
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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