Microbiology Testing - Managing a Microbiology Process

[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]

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

Hello Jenny and welcome to the Cove

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.

 

[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