Microbiological testing is seldom effective for monitoring CCPs due to time consuming nature. Rapid microbiological screening test for pathogenic microorganisms generally take 48 hours to determine potential ‘positive sample’.
Confirmations of these positive samples may take several more days.
It is not feasible to hold 2-4 days of production while awaiting the results of microbiological testing.
Not would most manufacturers want liability on 2-4 days of production that may need to be reworked or destroyed.
Furthermore, the probability of detecting a microbiological pathogen that is contaminating a product at a low level is extremely.
There is a 0.1% to 5.8% chance of detecting the microbiological pathogen. The higher rate of detection tested 60 samples. The cost to test 60 samples per lot, coupled with 5.8% chance detecting the pathogen (0.1-% defect rate), make microbiological testing ineffective and inefficient.
Establishing Limits for Critical Control Points: Microbiological
