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 SDA 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
I don’t know anything about pharmaceuticals but I am always happy to learn something informative and important.
The idea of having mold or bacteria in our medicines is so scary! Glad they have a procedure to keep this from happening!
I wouldn’t even know where to start when it comes to pharmaceuticals! Great knowledgeable post!
These details are very helpful when doing microbial monitoring. We should be careful to follow procedures as set out.
This is super interesting! I know almost nothing about this topic so I always love to learn new things
Good to know that they are checking for bacteria and mold. A lot goes into drug making.
I have to admit I know little about pharmaceuticals – this sounds like interesting information though and a great help to many.
Wow! What a great read. This is so informative article and I love sharing article like this.
The article is so informative, thank you for your perspective.
Didn’t realize there’s testing for bacteria, fungus, etc. in drugs. You learn something new all the time!
xoxo
Annie
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.
I know nothing about this topic, so it’s very assuring to know that there are people out their who are knowledgeable about this.
I absolutely knew nothing about this before I found this. Such great information!
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.
I used to know a bit more about this kind of stuff. Glad to have a refresher!
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.
You have an in-depth knowledge about this topic my friend. Great Information!
It’s good to know that this is also being shared to readers. Such a great way to spread awareness as well.
Thanks for sharing this important data. I don’t know about microbial and other pharmaceutical terms but these are very useful.
This was all new to me as I know nothing about microbial or pharmaceutical terms. Thanks for allowing me to learn something new today.
Tell me what is the reference.
This is In-house SOP. You can go for In-house Microflora and control measures study.
May I know the reference sources for this topic? which guideline and under which clauses mentioned this.
Hi, this is In-house SOP we have studied our In-house Microflora and conducted study likewise. By using that study we have prepared SOP.
How to do you Pour SCDM into plates?
I understand it’s a broth and not Agar.