QLA now offers Enhanced Mechanical Calibration (EMC) Services and a new ASTM Validation Tool Kit.
In January 2010, the FDA issued draft guidance supporting the use of an Enhanced Mechanical Calibration (EMC) procedure as an alternate approach to the current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 as described in the USP General Chapter <711> Dissolution. QLA can now perform EMC services as described in ASTM E 2503-7 for customers who may choose to implement this procedure.
Our trained staff will perform physical measurements and document critical parameters such as Spindle Drive RPMs, Vessel Verticality, Paddle Shaft Verticality, Basket Shaft Verticality, Vessel Centering, Paddle Shaft Wobble, Basket Shaft Wobble, Basket Wobble, Paddle Height, Basket Height, Waterbath Temperature and Vibration. All QLA Calibration Tools and Gauges are certified to NIST traceable standards. The new ASTM Validation Tool Kit is also available for those labs that perform their own calibrations.