OptiMelt Automated Melting Point System - Stanford Research ...

Maintenance and Calibration 63Chapter 4Maintenance and CalibrationThis chapter includes basic guidelines and recommendations for keeping your OptiMelt calibrated and inexcellent working condition. Detailed instructions are listed for:(1) temperature offset calibration(2) camera threshold adjustment (Onset%, Single% and Clear%)(3) camera optical alignment(4) removal of broken capillaries(5) cleaning the unit’s exteriorTemperature Offset CalibrationChemical quality control (QC) laboratories must test their analytical instrumentation on aregular basis against Certified Reference Standards (CRSs) to determine the“acceptability” of their equipment according to specific QC requirements set forth bylocal, national and international standards and pharmacopeia laboratories.Each OptiMelt system uses three temperature offsets to adjust its thermometer readingsand display calibrated melting points between 40 ºC and 300 ºC. An Acceptability Test isprovided for the user to check the temperature calibration and to apply corrections ifnecessary.To determine if your OptiMelt is “Acceptable for Melting Point Determinations”, followthe guidelines below and the flow chart in Figure 35.• OptiMelt systems are calibrated at the factory prior to shipment against O100MPSCRS Kit standards (Appendix B) using 1 °C/min ramping. There is usually no needto test the calibration of a brand new instrument unless: (1) specifically required byyour incoming inspection protocols or (2) ramping rates other than 1 °C/min arerequired for your routine MP determinations.• If the calibration of the unit is in doubt, or if no proper GLP documentation isavailable for the calibration data, perform an Acceptability Test on the instrumentfollowing the instructions in the next section.• If the expiration period for the temperature calibration has expired, perform anAcceptability Test on the instrument following the instructions in the next section.The expiration date for the temperature calibration of your OptiMelt is listed in theOptiMelt Automated Melting Point System