Sterility Testing vs Bioburden Testing - Differences

[mobylad]

What is the difference between the above two?

 

[bio_subbu]

What is the difference between the above two?

Bioburden testing:

Bioburden test is performed to determine the number and nature of microorganisms on a product prior to sterilization.

According to the standard ISO/TS 11139:2006 (Sterilization of health care products ? Vocabulary), the definitions of sterility, test for sterility & bioburden are listed below;

Sterility:

State of being free from viable micro-organisms. [ISO/TS 11139:2006]

Bioburden:

Population of viable micro-organisms on a product and/or sterile barrier system. [ISO/TS 11139:2006]

Test for sterility:

Technical operation defined in an official pharmacopoeia performed on product following exposure to a sterilization process [ISO/TS 11139:2006]

Test of sterility:

Technical operation performed as part of development, validation or requalification to determine the presence or absence of viable microorganisms on product or portions thereof. [ISO/TS 11139:2006]

 

[mobylad]

So if the both are measuring for bioburden? Do they use the same test method? except one (i.e. the sterility test)is expecting a zero bioburden result?

 

[v9991]

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[Ajit Basrur]

So if the both are measuring for bioburden? Do they use the same test method? except one (i.e. the sterility test)is expecting a zero bioburden result?

Yes the intent of both tests is the same to check for microorganisms but Sterility Testing has a wider and deeper implication.

In Sterility Testing, the intent is to find if the batch is sterile / non sterile and only 2 liquid media - Trytic Soy Broth (for aerobic organisms) and Fluid Thioglycollate Broth (for anaerobic organisms) are employed and any growth in the media indicates that the batch could be contaminated and requiring further investigation. There is lot of considerations to be given for sample size too.

Bioburden test is to assess the load of the organisms in the articles and hence different solid agar are employed - each for bacteria, mold and yeast and different objectionable articles.

Incubation periods are different in both tests.

You could also take a look in the European Pharmacopoeia or the British Pharmacopoeia for more information.

Let us know if you have additional questions
.

 

[somashekar]

If I can add to Ajit's response, bioburden test is also to assess the challenge in the work environment that could have a direct bearing to the effectiveness of the product sterilization process.

 

[mpfizer]

Yes the intent of both tests is the same to check for microorganisms but Sterility Testing has a wider and deeper implication.

In Sterility Testing, the intent is to find if the batch is sterile / non sterile and only 2 liquid media - Trytic Soy Broth (for aerobic organisms) and Fluid Thioglycollate Broth (for anaerobic organisms) are employed and any growth in the media indicates that the batch could be contaminated and requiring further investigation. There is lot of considerations to be given for sample size too.

Bioburden test is to assess the load of the organisms in the articles and hence different solid agar are employed - each for bacteria, mold and yeast and different objectionable articles.

Incubation periods are different in both tests.

You could also take a look in the European Pharmacopoeia or the British Pharmacopoeia for more information.

Let us know if you have additional questions
.

"There is lot of considerations to be given for sample size too."

If there is a validated procedure for sterilization, is there still a need to follow the number of pcs to be tested after sterilization for sterility as per USP, i am referring to sterile medical devices and the total lot size is more than 500 numbers please advise

Thanks

michelle

 

[Yousuri]

Hi,

Im not sure if this is the right thread to post this to, but ill try.
I have an SOP for Gamma Sterilization of a Class I device but im lacking the following items in the procedure:
• Include bio-burden monitoring as a stand alone action.
• Add trending
• Establish action alerts and action limits for bio-burden.

Would somebody have a SOP that would have these actions in it? I just dont want to have to re-invent the wheel if its readily available?
Thanks!
Yousuri