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Bioburden Frequency (sterile MD)

#1
Hi!
I'm Arianna, QA of a sterile implantable manufacturer.
I should set the frequency of bioburden determination on dm sterilised by EtO, dry heat and gamma rays.
Regarding gamma rays, the ISO 11137-1 sets the frequency at 3 months. For the other two, I have not found anything.
Do you know if there are any specific ISOs? Or do I just write a rationale for the fixed frequency? And if so, which parameters should I choose in your opinion?

I'm sorry for all these questions, but our NB gave us a non-compliance during the surveillance visit and I have trouble justifying the frequency of 6 months rather than a year!

Thank you so much!
 
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#2
Take a look at ISO11737-1 Section A8, this will give you advise on determining the frequency for monitoring bioburden. I have quoted some below.

A rational choice for the frequency of monitoring should be made, taking into account a variety of factors including the following:
— the availability of historical data;
— the purpose for generating the data;
— the nature of the manufacturing process;
— the production frequency for the product;
— the criticality of detecting bioburden changes in a timely fashion;
— seasonal and environmental variations.

Sampling can be performed at a frequency based on time (e.g. monthly, quarterly), or on production volume (e.g. alternate batches). However, in order to establish baseline levels, it is common practice to determine bioburden at a higher frequency during the initial production of a new product and for this frequency to be reduced as a knowledge of bioburden develops.

The frequency of determinations of bioburden should allow detection of changes in bioburden, for example, due to seasonal variations, manufacturing changes or changes in materials.


The consistency of the bioburden is more important than the absolute level, so start testing frequently to set good baseline data then you can reduce the frequency as you. Unless you have very good data to back it up, 6 monthly or annually would be too long.
 
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