Why ProCellics™ is GMP
In the same way current sensors are used in bioproduction, ProCellics™ does not need any GMP approval, from a regulatory agency for instance. GMP compliance results from the characteristics of ProCellics™ and from the way it is implemented in production.
ProCellics™ hardware is fully GMP compliant. The hardware is IP65, meaning that it can be sterilized according to standard procedures using decontaminant sprays. The probe is designed so that there is no glue in contact with the culture. It is autoclavable and designed for CIP/SIP.
The software includes features needed to guarantee data integrity and to be used in compliance with CFR 21 part 11.
The calibration process needs a development phase but is not inconsistent with a use in GMP. In fact this approach is similar to HPLC or mass spectrometer which needs a calibration development phase during which measurements are made with reference material.