Particle decontamination of gloves consists in removing any particles and fibres from the outer and inner surfaces of the gloves. The residual particle level is compatible with the glove's use in a class 100 isolator. This particle level, in accordance with the IEST SD 1246D standard, is of circa 200.

Decontamination, drying and packaging are performed in a class 1000 room.

Gloves are double-packed in polyethylene, the 1st layer of which (contact with glove) possesses a 1000 rating.

We can provide particle and fibre counts, along with pouch drying and sealing analyses.

All commercial ELS gloves, glove box gauntlets,, arm guards and rings are sterilised by Gamma irradiation of devices that have previously undergone particle decontamination.

Glove sterility is ensured by:

• Gamma sterilisation between 25 and 50 KGy

• Irradiation dose validation over 3 successive runs using dosimeters

• Validation of microbiological control methods

• Microbiological and mechanical testing at T0 after irradiation

• Microbiological and mechanical testing at T1 year, T2 years and T3 years

• VDmax 25 calculations: the glove's initial bioburden shows that irradiation with 8.9 kGy is sufficient to sterilise the glove.