Temperature Mapping packages
The typical number of measuring points required by ICH Q1A (R2) on small to medium sized stability chambers is 9 (4 corners top and bottom shelf+ center) – fixed directly on the shelves in empty/loaded chamber. For larger chambers it is recommended to place 5 measuring points on minimum 3 layers or even on each layer with sample readings every 1- 5 minutes during 24/48 or 72 hours.
As example the acceptance criteria for a standard stability chamber with setpoint of +37°C is that all measurements throughout the chamber do not individually differ by more than 2°C for temperature and 5°C for relative Humidity.
Typical validations include:
Up to 15 temperature points logged over 24 hours.
Up to 12 humidity points logged over 24 hours
Labserv Mapping Packages
TM1 – Temperature – PM/OQ ( Laboratory Ovens, Incubators )
OQ is Temperature Set point ºC Customer Required Temperature Limits +/-ºC Confirm Temperature Chamber Loading % Temperature Mapping Period Temperature Mapping intervals
TM2 – Temperature & Humidity – PM/OQ ( Stability, Environmental, ) ICH/FDA compliant
OQ is Temperature Set point ºC Humidity Set point %RH Customer ( ICH Guideline) Required Temperature Limits +/-ºC Customer ( ICH Guideline) Required Humidity Limits +/- %RH Confirm Temperature & Humidity Chamber % Loading Temperature & Humidity Mapping Period Temperature & Humidity Mapping intervals
TM 3. – Refrigeration (-10-20-80)
OQ is Temperature Set point ºC Customer Required Temperature limits +/-ºC Customer Required Recovery (door opening and power down) Temperature Mapping.
Equipment: Climate Chambers, Environmental Chambers, Temperature Humidity Chambers, Oven, incubators, Walkin Chambers, Fridges.
Manufacturers: Binder, Vindon, Memmert, Thermotron, Weiss Tecknik (Gallenkamp), TeslaTest
Contact us for a quotation here
Or view the full range of laboratory equipment supported here