E-Beam Sterile Conditioning of FabOhio Inc. Glovebag

The study was performed at an E-Beam facility in Ohio.

A certified testing laboratory in Cleveland prepared multiple test strips inoculated with known concentrations of 12 organism recognised as suitable candidates.

FabOhio Inc. had provided a large glovebag folded ready for shipment with 2 over pack layers all in a standard sealed shipping box.

The labs technician opened the box and overpacks and interspersed test strips within the multiple folds of the glovebag as well as the overpacks and the shipping box.

The box was placed on the belt and sent through the E-beam. It was then turned over and re-sent through the beam a second time.

The initial exposure was at a level used for other clients (J & J sample bottles) and a second glovebag was also irradiated at 10 times the conditioning level to evaluate for damage at the high concentration.

The glove bags were returned to FabOhio Inc. for inspection and visual recording. No structural damage was in evidence although a faint yellow discoloration of the film was visible at the 10X dosage level.

The lab technician returned to Cleveland with the exposed media for assay. The lab reported extinction of all 12 organism at 1,000,000 (or 106) efficacy at the pre-selected dosage level. One million counts was the upper limit of the methodology.

Written by Brian Ward, PhD, CSci, CChem, FRSC

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