The US patent, filed in 2008 but given approval last week, uses a ferro-electric random access memory chip (FRAM) chip to store error-correctable information on a radio-frequency identification (RFID) – similar to those used in biometric passports – which is attached to single-use components.
Whilst there are other patents that track and store information about bioprocess equipment on an RFID chip, this invention “is able to authenticate and prevent illegal manufacturing of disposable bioprocess components, especially those that are sterilized by gamma irradiation or other suitable means of lowering bio-burden of the disposable or limited reuse device,” the patent states.
Furthermore, “this invention includes a method for authenticating the disposable bioprocess component that reduces liability in that a counterfeit poor quality disposable component is not used on the hardware so the user will not file an unjustified complaint.”
Biopharma-Reporter.com contacted GE Healthcare for more information regarding the need to prevent unauthorised operations of single-use systems – whether it be counterfeit drugs or bioweapons – and how this tracking device prevents this, but were told it was the firm’s policy “not to comment on any patent related issues prior to product launch due to commercial sensitivities.”