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 :
2 Perkin Elmer® gas chromatograph equiped with
a capilar column 50 m lenght
with an headspace sampler can proceed to 40 analysis during one series for the first one and 110 analysis for the second one.
Reference standards :
According to the Standard ISO 11135 (2014) 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, by medical devices and according to its duration of contact with the patient, the limits of residual ethylene oxide, ethylene chlorohydrate and ethylene glycol not to be exceeded. Note that this standard was updated in October 2008 to limit the level of allowable residue.
Testing methods :
- Exhaustive extraction method is applied to extract the total amount of residues and to reach the most unfavourable conditions.
- Method by simulation of use at 27 ° C or 37 ° C
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.