Assessing coring and fragmentation in medical devices

Assessing coring and fragmentation in medical devices

When piercing an elastomeric septum with a needle or spike, there is an inherent risk of coring the material – increasing the risk of fragmented contaminants in the drug product.

Download our whitepaper by Smithers expert Sarah Ellis to find out more about how a testing program can help assess and mitigate the risk of coring.

This whitepaper provides an expert summary of:

  • The importance of testing for coring and fragmentation
  • The factors which affect the risk of coring and fragmentation
  • The testing procedure for assessing coring, and subsequent analysis of potential contaminants 
  • The relevant regulatory standards for coring and fragmentation.
Find out more about our medical device testing.

Download the whitepaper below:


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