The freeze drying or lyophilisation process requires both monitoring and validation of the process chamber.
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 21CFR 610.13 will be satisfactory.
Although thermocouples and pressure transducers can be connected to a logger/recorder outside the process chamber for lyophilization 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.