Microbiology Testing - Managing a Microbiology Process

J

JennyGernon

Hi all

I was interested to see how you all manage your microbiology process. We currently process our microbiology as follows

test lenses every 6 months, write up Process Validation Report. Confirm if there are any non conformances or not.

I recently had a tech file review and was advised that I need to include information in our tech file on bioburden. I keep this separately at the moment and was interested to see if others put microbiology information in their tech files.

Regards

Jenny
 
Ronen E

Ronen E

Problem Solver
Moderator
JennyGernon said:
Hi all

I was interested to see how you all manage your microbiology process. We currently process our microbiology as follows

test lenses every 6 months, write up Process Validation Report. Confirm if there are any non conformances or not.

I recently had a tech file review and was advised that I need to include information in our tech file on bioburden. I keep this separately at the moment and was interested to see if others put microbiology information in their tech files.

Regards

Jenny
Click to expand...

Hello Jenny and welcome to the Cove :bigwave:

A lot of context is missing. "Microbiology process" can be many things. What does your org do? From your post I gather you manufacture some medical devices. Is that correct? Are those sterile medical devices? Were you referring to a NB audit?

The more context you provide, the higher the chances you will get useful responses (though it's not guaranteed...)

Cheers,
Ronen.
 
Last edited:
J

JennyGernon

My organisation manufactures Custom made devices and Scleral Contact Lenses.

We send our Gold Eye Lid Weights and Scleral lenses to a bioburden company for testing every 6 months.

At a recent review, I was advised that bioburden reports needed to be included in technical files so I was just trying to see what information I need to include in these.

We currently include information on Process Validation forms, Bioburden reports and contract information with our Bioburden company.

Thank you
 
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