TO ALL NITRITEX DISTRIBUTORS

We recently received a complaint from an end-user of our sterile BioClean-D coveralls that our product was faulty. On investigation, we established that the product in question was a non-sterile coverall that had been gamma sterilized by the distributor. It was this unauthorised processing that caused a serious deterioration in the coverall material.

Please take note that where we sell sterile and non-sterile versions of the same product the starting products are not necessarily identical. Gamma irradiation causes significant deterioration in some of the materials used so we have to adapt the design to ensure similar performance between the sterile and non-sterile products. The differences can mean that the price gap between sterile and non-sterile is greater than the cost of irradiation alone. Apart from the recent issue with BioClean-D we have, in the past, had a similar occurrence with the irradiation of our non-sterile tie-on face masks (MTA 210-2). The filtration efficiency of the mask is severely degraded by the irradiation process but the mask looks perfectly normal, so we developed the MTA 210-1 which looks and performs the same as the MTA 210-2, but has a different make up.

We stand behind the high quality of our BioClean brand, and the practice of sterilizing non-sterile products is damaging our name. We would appreciate if this practice were to cease with immediate effect. If sterile products are required it is not safe to presume that the non-sterile version can be irradiated; please purchase the sterile items from us.

Thank you for your cooperation.

Peter Clarke
Head of Quality & Regulatory Affairs