Kryologger hardware is IQ/OQ validated and fully documented in the available workbook.
There is complete validation of the system for auditors to meet FDA and EMEA approval
requirements
The KT70 was 2002 Winner at the Medical Design Excellence Awards
Patents
KryoTrans container/logger technology is patent protected in the US and UK and there
are patents in place to protect KryoTrans technology
The granted and current patents are
- 4974423 granted in the USA for 'frozen' temperatures, a container with integral
logger and for frozen temperatures a container with separate compartments for refrigerant
and load
- EP 00942180.1 granted in the UK and Ireland a container with onboard heat and cold
banks regulated by Peltier controllers and a container with an onboard logger which
calculates the real degradation with temperature of the material in the load
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