Garment sterilization

Hello good morning ,
I work in OSD plant as QC microbiologist.
I do MLT test for non sterile products in bio safety cabinet.
So my query is
There’s is required to wear sterilized garments in microbiology lab or MLT room.?

No. It is not mandatory to use sterile garment in microbiology of QC Lab of non-sterile products manufacturing facility.
However, the garment should be dedicated to be used in microbiology section and must be suitably disinfected.

On the basis of which guideline can I justified against that ouditor?

There is no specific guideline for this aspect. It is general industry practice. However, we can also use strile garmants to work in microbiology room where non-sterile product testing is carried out such as Microbial limit tests (MLT), Microbiology assays, Qualitative identification of microorganisms etc. The use of sterile garments depends upon risk assessment which must be carried out for type of products, type of microbiological cultures (microorganisms) and microbial test methods being used.

Ok thank you sir.

You are always welcome.

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https://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodPracticesPharmaceuticalMicrobiologyLaboratoriesTRS961Annex2.pdf?ua=1

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