Download paper: 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 programme 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

Download via the link below.