Must Bioburden Sampling Procedures be Documented?

[nicoles6]

Hi all,
I work for a MEMS manufacturer that makes a component for a medical device (we are not the final device). Bioburden testing is done but there is no documented procedure on how to handle these samples before testing.

Does anyone have experience with this and what a possible procedure might be? I'm mostly concerned with handling/storage of our gel packs.

Thank you!
Nicole

 

[Ronen E]

Hi Nicole,

If a specific bioburden limit is spelled out in the contract with your client, I'd expect that a written procedure be in place to define how bioburden samples are collected and handled. Otherwise the process would lack control and perhaps consistency and that might affect the final bioburden results.

This presentation might be of help.

Cheers,
Ronen.

 

[nicoles6]

Thank you Ronen. The presentation did help.
There is currently no bioburden limit yet set, but I can see one coming. I think for the most part I can update our procedures for handling and sampling... except for the gel pack. That one I'm not quite sure how to handle.
Nicole

 

[Ronen E]

Do you make them in-house or source them? If the latter, maybe ask the supplier / manufacturer?

 

[nicoles6]

The gel packs? We do source them so that's a great suggestion - thank you!

 

[bjohnsonrli]

Hi Nicole,

My experience has been with product bioburden testing in its final finished form however, I would think that some of the same principles would apply.

1. The handling of samples should be to avoid the introduction of inadvertent contamination and significant alterations to the amount of microorganisms in the samples.

2. Samples should have undergone all essential stages of production, including cleaning (if applicable) and packaging processes (as your customer would receive it).

3. If bioburden is of concern, then final packaging should provide a microbial barrier to prevent the ingress of microorganisms.

As Ronen suggested, work with your suppliers accordingly.

Regards,

Bryan