The Growth Direct™ System performs automated cassette incubation, colony enumeration and reporting using a media cassette that contains a growth media as required in the Pharmacopeia to show viability of microbial cells through growth.
Testing performance of the Growth Direct™ System consumables is identical to standard media plates and as defined in the USP/EP micro chapters. The key system components to validate are
As an automated colony counter the validation requirement, as defined in the PDA TR33, will only be accuracy and precision of the system compared to the gold standard, the analyst. These two requirements are the same as required for the validation of standard micro methods when spike and recovery experiments are performed. Good precision is required to give good CFU estimates to compare to the control inoculation for accuracy determination.
The approach has been used at a number of pharmaceutical sites who have received regulatory approval to perform water and bioburden testing on the system.