SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.

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SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.

PROCEDURE:

  • Carryout the microbiological testing of the drain as per procedure mentioned below.
  • Prepare the swab sticks. After sterilization mark the swab sticks with location I.D. and date of sampling.
  • Take the swabs at the respective area and withdraw the sample from critical point of drain.
  • Vortex the tubes along with swab and use the suspension for further analysis.

 

  • Total Fungal Count:

Media to be used: SDA.

               

  • Pour Plate Method: This method is to be used for estimation of total fungal Counts.

Inoculate 1ml of sample in duplicate, in pre-sterilized Petri plates.

  • Pour pre-sterilized molten SCDM  into these plates. Keep inoculated and uninoculated medium plates as positive and negative controls respectively.
  • Incubate the plates.
  • Count the number of colonies on each plate and express average for the two plates in terms of cfu/swab.

Record the results in Annexure.

  • Total Aerobic Bacterial Count:

Media to be used: SCDA           

 

  • Pour Plate Method: This method is to be used for estimation of total aerobic Bacterial counts.
  • Inoculate 1ml of sample in duplicate, in pre-sterilized Petri plates.

 

  • Pour pre-sterilized molten SCDA Into these plates. Keep inoculated and uninoculated medium plates as positive and negative controls respectively.
  • Incubate the plates.
  • Count the number of colonies on each plate and take the average of the two plates in calculation as per dilution factor (1:10) and express the result in cfu/swab.

 

Pathogen Testing: Pathogen testing should be done as per normal pathogen analysis

  • Test for Escherichia coli:
  • Test for Salmonella
  • Test for Pseudomonas aeruginosa
  • Test for Staphylococcus aureus

 

Note:     When using any medium, positive inoculated control and negative control shall be employed to check fertility and sterility of the medium respectively

 

FREQUENCY:  Frequency should be  Inhouse.

  ACCEPTIONS CRITERIA: Acceptance criteria should be identify By Inhouse technique

  • For Bacteria *** CFU/ swab
  • For Fungi *** CFU/ swab
  • Pathogen Absent/swab

 

20 thoughts on “SOP For Microbial Monitoring in Drain Point of Pharmaceutical Manufacturing sites.”

  1. I have to admit I know little about pharmaceuticals – this sounds like interesting information though and a great help to many.

  2. I feel this article was extremely necessary and wish more was said to the public about it. It’s so sad to see other countries being succumbed to malnutrition or disease because testing is not a viable option for them.

  3. Well, I wish someone could make a kit that we can use at home to atleast check the bacterias whatever we get in contact with or with what we ingest, when we need to.

  4. Standard operating procedures are a great place to start to gain knowledge about a subject. It looks like you put a lot of effort int creating this one.

  5. Thanks for sharing this important data. I don’t know about microbial and other pharmaceutical terms but these are very useful.

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