Control of ethylene oxide residues
Thanks to its efficient installations and a specialized team, Steriservices offers you the possibility of carrying out dosages of gas residues.
allowing you to market your products in accordance with current standards without risk to the patient.
allowing you to market your products in accordance with current standards without risk to the patient.
Description of the equipment :
2 Perkin Elmer® Gas Chromatographs including:
a 50 m long capillary column operating in Headspace.
Sample changer for analyzing up to 40 samples in a single series for one
and 110 samples for the second.
Reference standards:
The ISO 11135 (2014) standard requires proof that the level of gas residues after sterilization (and where applicable after aeration) is below the specified limits.
The international standard ISO 10993-7 (1996) provides, by medical device and according to its duration of contact with the patient, the limits of residual ethylene oxide and ethylene hydrochloride not to be exceeded.
Note that this standard was updated in October 2008, aimed at restricting the level of admissible residue.
Residue control methods :
– Exhaustive extraction method in order to recover all the residues and therefore to place themselves in the most unfavorable conditions.
– Method by simulation of use at 25 ° C or 37 ° C.
All assay methods must be validated.
Services offered :
Dosages on products sterilized on our site but also on products from all over the world (consult us for the transport conditions of the samples).
Aeration validation including validation of the assay method and validation of aeration time and conditions.
Routine assay including validation of the assay method and assays after routine sterilizations.
Verification of the effect of successive cycles on the gas residues.
Others activities
