An alternative to CSM

Published: 31-Aug-2018

Bioclean introduces validated sterile and clean nitrile RABS and isolator gloves

The validated sterile nitrile RABS and isolator gloves have been approved for use in R&D and injectables manufacturing facilities.

The gloves offers reasonable lead times, easy tear triple poly bag packaging and no paper products are used in shipping materials.

  • fits 8”, 10” and 12” ports
  • low levels of particles (tested in accordance with EST-RP-CC-005.4)
  • excellent ESD properties
  • manufactured from accelerator-free, biodegradable nitrile: a safe, non-outgassing material
  • meets ASTM D6978-05 standard for handling chemotherapy drugs
  • 100% inspected, water and air leak tested
  • gamma irradiated with Sterility Assurance Level of 10-6
  • COIs and COAs available
  • individually triple bagged in easy-open PE
  • excellent resistance to VHP and can be autoclaved multiple times
  • category 3 – complex design PPE compliant

Bioclean’s gloves are cleanroom laundered in an ISO 4 facility, not simply wiped down with IPA before gamma irradiation. They are available in a variety of sizes to fit circular and oval ports including most standard sizes as well as custom orders.

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