Given the recent publication by FDA of the revised 21 CFR part 113 rule, food industry processors and their thermal process authorities in almost every state need to decide whether to replace the MIG’s and, if so, the pace and protocol for transitioning away from the mercury containing reference instruments.

There is no single, uniform transition mechanism or protocol in place. Technical authorities differ widely on whether there should be a gradual transition with documented comparison of old vs. new reference instruments in situ or not. Some suppliers and technical consultants endorse a more aggressive path forward and stipulate that all that is required or reasonable is  following the required NIST or equivalent calibration schedule.  Their main argument seems to be that a substantial database on the reliability of the instruments has already been accumulated and evaluated by industry and FDA, with positive results.

Stock America’s technical support group strongly supports the move away from MIG thermometers but we do believe some caution is needed in transition.  Different sterilization systems and applications have unique characteristics and some overlap of existing MIG’s and new DRT’s is recommended to gain a comfort level on the ‘installed’ reliability of the new device.  The duration of the transition protocol can be fitted to the circumstances.  The in situ comparison also develops the confidence of technicians, retort operators and supervisors that their process is monitored safely and correctly.