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Biocompatibility Evaluation component other than Testing

J

Juzaili

Involved In Discussions
#1
#1
Dear All

Please anyone clarify Biocompatibility evaluation component other than testing..


I need a further understanding on this part..

Another question for which I need your assistance.

for gamma sterile
we buy dose mapping on A product.
can we used this dose mapping on B products that about +- 10% of weight and same material used and same packaging..
can we used dose mapping on Product A on the Product B??
 
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planB

planB

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#2
#2
> Please anyone clarify Biocompatibility evaluation component other than testing..

Please have a look at ISO 10993-1:2009, section 4 and also Figure 1 contained in this section. This should give you a clue how this evaluation process works.

> can we used this dose mapping on B products that about +- 10% of weight and same material used and same packaging..

You may want to establish a processing category or product family for your sterilization process. Document your rationales following ISO 11137-2:2013, sections 4.2, 4. and 4.4. When you have achieved this, you may have rationales at hand why your existing dose mapping also applies to your candidate product B.

HTH,

Gerhard
 
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