Mechanical Qualification Device – MQD
The SOTAX MQD helps to improve and simplify the implementation of the enhanced mechanical calibration for any dissolution bath (USP 1 and 2) regardless of brand. It simplifies the overall qualification workflow and eliminates the complex qualification tool kits.
- DESIGN – Universal Tool: Works with any dissolution system (USP 1 and 2), supplier-independent, for open and closed head designs, also works with 1 L and 2 L vessels (independent from vessel height)
- 100% regulatory compliance: all measuring points as per regulatory requirements according to USP chapter <711> and FDA guidance for industry (§ 211.160 (b)(4)); regulatory specifications are stored in firmware, changes via firmware / software update
- Raw data storage on firmware
- Selectable qualification norms
- Automatic compliance check
- Electronic data acquisition and reporting: eliminates manual reading and reporting errors and provides reliably precise data
- Contactless meas?ements: no risk of damaging coating or glassware (vessels)
- Wireless data transfer: data transferred via Bluetooth to computer for reporting
SOTAX Solution for Enhanced Mechanical Qualification: MQD