‘Ensuring your temperature apparatus is capable of accurate and repeatable performance.’
For the approval of pharmaceuticals and providing evidence of stability tests, steps must be taken to ensure that the stability test chambers function
correctly, e.g. that fluctuations in temperature and humidity remain within the stipulated range and this over relative long periods of time.
All stability chambers should meet ICH Q1A (R2) guidelines for pharmaceutical stability testing which provides recommendations on stability testing protocols including temperature, humidity and trial duration. Validation must be carried out regularly to ensure that an environmental room or cabinet is capable of accurate and repeatable performance.
Vinden, Binder, Weiss Gallenkamp, Thermo, Memmert, Hereaus, Carbolite, Sanyo, Jenway, LEEC
NLG Labserv are able to draw upon over 10 years experience of mapping ALL brands of Laboratory Stability Chambers; Environmental, plant growth, general laboratory ovens, Fridges and Freezers.
Engineers are located throughout the UK receive extensive training on ICH Q1A (R2) Guidelines and in some cases have been trained directly by the OEM’s to perform validation (regular, accelerated etc.. ) within every size of chamber.
For pure Temperature logging we use Ametek Jofra Dry Block – Advanced Temperature Calibrators with Fluke Data integrator and ‘Lives’ CFR Part 11 Software.
For Temperature and Humidity, we use state-of-the-art Hanwell RH-T loggers and software which is again FDA compatible.
Each probe is calibrated, every 6 months and accurate to a minimum accuracy of +/- 0.1 Deg oC
Qualification is performed in accordance with predetermined and approved qualification Protocols, the results of which are recorded and reflected in qualification reports.The OQ also contains information about calibration of measuring equipment and defines the location of the thermocouples and the data loggers in the stability chamber.
View our temperature mapping packages here
Request a quotation here