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Gas residual testing

 

 

 

Thanks to a high-performance equipment and a specialized team, STERISERVICES offers you the opportunity of testing gas residuals permitting you to deliver your products without risk for the patient.

 

 

Equipment specifications :

A  Perkin Elmer® gas chromatograph equiped with a capilar column  50 m lenght with an headspace sampler can proceed to 40 analysis during one run.

 

 

 

Reference standards :

According to the Standard ISO 11135 (2007) the levels of residual ethylene oxide and/or its reaction products after sterilization shall be determined to demonstrate that the levels are below specified limits.

The International Standard ISO 10993-7 (1996) provides, according to the medical device and its length of patient contact time, the acceptable levels of ethylene oxide, ethylene chlorohydrin and ethylene glycol.
A new version of this norm have been published in october 2008 which will reduce the level of residues.

 

 

 

Testing method :

Exhaustive extraction method is applied to extract the total amount of residues and to reach the most unfavourable conditions. The testing method shall be validated.

 

Services offered :

 

Items testings that have been sterilized on our site but also that come from over the world (contact us for samples shipping conditions).
 
  • Aeration validation including the testing method validation and the time and conditions of aeration validation.
  • Routinely testing including the testing method validation and testing after routine sterilization process.
  • Control of the effect of successive sterilization processes in term of gas residues.