CALEVA 10 + ST
The CALEVA 10+ST is a high standard dissolution tester, designed to meet increasing validation and qualification requirements.
Three lights at the front panel (Green, Yellow, and Red) show the degree of USP/EP compliance. In case of not meeting the specifications (temperature, rpm*, height adjustment*, validation interval, qualification interval, service interval) the RED light, or in case of a minor problem a YELLOW light, appears (*optional).
The integrated System Suitability Test Menu guides the user step by step through a validation qualification. The results can be entered via the numeric keypad or downloaded automatically to the unit when OQ tools with an interface are used; hard-copy documentation can be printed when a standard printer is connected to the parallel printer port.
The FDA sub-menu allows an external auditor to receive all information in hard copy form within seconds.
The 10+ST offers: one-piece molded PET water bath (1000 ml version only), powerful external flow-through heating system to avoid vibration, electronic PT 100 temperature sensor with one point calibration and calibration documentation, automatic height adjustment of the stirrers (by unscrewing the stirrer and exchanging with another stirrer), automatic vessel centering and membrane sealed “low-evaporation” vessel covers, optical and acoustic reminder for sampling intervals, USP/EP compliant routine for test start with baskets, 2 x serial interfaces, 1x parallel interface, 1 x OQ tool interface, user configuration of most equipment parameters, etc.
In addition the 10+ST can be used to control a Caleva Offline Dissolution System with the Caleva FC10 Fraction Collector. Caleva Online Dissolution Systems are also available using Caleva Dissolution Software.
Features
- • Three color Traffic Light for USP/EP compliance check
- • Validation, Calibration and Service Interval display
- • Validation Test Menu with data entry and documentation print-out
- • Full electronic configuration of the unit by the user
- • Hours of operation counter
- • Infinity Test on completion of the test
- • 8 USP/EP Glass Vessels, 1000 ml or 2000 ml
- • FDA sub-menu
- • Membrane sealed “low evaporation” vessel covers
- • Automatic vessel centering
- • 6, 7 or 8 Test Stations (stirrers)
- • 8 USP/EP stainless steel Shafts and Paddles
- • Wobble < 0.3mm at delivery (Paddle)
- • Electronic telescopic lifter
- • No height adjustment required for stirrers
- • USP/EP compliant start routine for baskets
- • One-piece molded PET water bath
- • External 2000 watt flow-through heating system, accuracy ± 0.20C, heat up time approximately 15 mins.
- • Electronic PT 100 temperature sensor with one-point calibration and calibration protocol
- • Reminder (optic and acoustic) for sampling intervals
- • Numeric membrane keypad and illuminated 4-line LCD
- • Serial RS 232 and 485 interface
- • Parallel printer port
- • OQ tool interface
