This will give assurance that the specified critical parameters of temperature and pressure are achieved; thereby increasing assurance that the determination of residual moisture standards issued by the FDA under 21 CFR 610.13 will be satisfactory.
Although thermocouples and pressure transducers can be connected to a logger/recorder outside the process chamber during freeze drying validation, this can be difficult because of the very low pressures, typically in the range of microbars, or fractions of a Pascal, required by the process.
Loggers such as TMI-Orion NanoVacq 1Tc-2Td (-80°C to +130°C) are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.
For more details please visit our Thermal Validation Systems page.