Microbial monitoring of Drain points

1.0 Objective
To lay down a procedure to describe the steps to be followed to monitor drain points for microbial load.
2.0 Scope
This Standard Operating Procedure is applicable for monitoring the microbiological load at drain points to be followed at formulation plant of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control are responsible for monitoring of drain points for microbial load.
3.2 Head Quality Control is responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
IPA : Isopropyl Alcohol
Ml : Milliliter
Cm : Centimeter
SCDM : Soyabean Casein Digest Medium
Hrs : Hours
ºC : Degree Centigrade
5.0 Procedure
5.1 Preparation of media and glassware
5.1.1 Prepare the media as per instruction.
5.1.2 Sterilize the media flasks and test tubes containing 10ml normal saline, Petri plate & accessories.
5.1.3 After completion of sterilization, remove the media and glass Petri plates, test tubes containing 10 ml

normal saline from the autoclave and cool it. Glass Petri plates dried in Hot air oven.
5.1.4 Maintain the sterilized Soyabean Casein Digest agar at 55°C.
5.2 Swab Sampling
5.2.1 Place all marked test tubes containing 10 ml normal saline in carrier box and transfer to sampling area.
5.2.2 Remove sterile swab carefully and place in the test tube containing sterile 10-ml normal saline

carefully remove the swab from the test tube. Select the surface to be tested & sanitize with 70 % IPA after sampling.
5.2.3 Take the swabs from select surfaces area (25 cm2) of each drain point.
5.2.4 After each swabbing, collect the swab test tubes corresponding to the location and transfer the samples

to Microbiology lab for analysis.
5.2.5 Under aseptic conditions, vortex the normal saline test-tube for proper extraction, remove a swab.

Using a micropipette with sterile tip, remove 1 ml of the sample for total viable aerobic counts and 1 ml for

pathogen transfer into SCDM.
5.2.6 Label the Petri plate, with sampling location, media lot Number and date. Incubate the

Soyabean Casein Digest agar plates at 30°C to 35°C for 72 hrs. & followed by 20°C to 25°C for 48 hrs.
5.2.7 Keep Negative control for each lot of medium prepared. Note down the details of media preparation

and growth promotion test.
5.2.8 Incubation the SCDM for 24 to 48 hrs and carry out testing for detection of pathogens.

(Escherichia coli, Salmonella spp, Staphylococcus aureus and Pseudomonas aeruugionsa).
5.2.9 Pathogen testing should be performed.
5.2.10 Limit for total bacterial count is 200cfu/swab and for total mould/yeast count <10cfu/swab

and pathogen should be absent.
5.2.11 Frequency of monitoring every month.
6.0 Forms and Records
6.1 Liquid Area Drain Monitoring Test Report – Annexure-1
6.2 External Area Drain Monitoring Test Report – Annexure-2
6.3 Tablet and Capsule Area Drain Monitoring Test Report – Annexure-3
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History

Revision Number	Details For Change	Reason for Revision
00	New SOP	NA

Microbial monitoring of Drain points

Reason for Revision

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