For the first time since its existence the American company Teledyne Hanson Research, the manufacturer of Vision dissolution systems, which are rightly popular among tablet testing laboratory personnel, has made a 14-position dissolution unit. The CD14 instrument may seem huge at first glance, but because it is able to do the jobs of two dissolution testers at the same time, it can be considered fairly space-saving in terms of space requirements. The manufacturer’s choice of name CD14 – Comparative Dissolution 14 – suggests that the instrument is an excellent device for comparative dissolution tests, including the bioequivalence tests of original and generic formulations, which require dissolution testing of 12 tablets, capsules or other formulations under the same conditions. However, due to its technical solution, the instrument is able to run not only one method at a time, but two!
It can be configured for 12-vessel or 2×6-vessel dissolution testing using the internal software of the instrument. On the 2×6-vessel system, two different formulations can be tested with different test parameters under the same temperature conditions. The operation parameters of the CD14 are set with an internal software which is clear, logical and easy to learn as it is always common with Hanson instruments, and by using its tilting touch screen. Its memory stores 500 methods, 100 users and 50 reports. It can also be equipped with the automatic tablet drop known with the Vision instruments and with temperature sensors (12-position) per vessel immersed in the medium during the measurement.
The CD14 certainly meets the requirements of the USP, EP and JP, as well as the requirements of the ASTM, and its internal software supports the compliance with the 21 CFR Part 11. As a novelty, in addition to the traditional use of a password, it is also possible to assign fingerprint identification to the users.
- mixing speed: 25 – 250 rpm ± 1 rpm (display resolution 0.1 rpm)
- bath temperature: 25 – 50 °C ± 0.5 °C
- heating unit: vibration-free heating circulator
- sampling: manually, later automatically
- sample filtration: double filtration option using end-of-tube sample filter and in-line syringe filter
- programming: via color touch screen
- 3 editable user levels
- memory: to store 500 methods, 100 users and 50 reports
- max. 3 electronic approval signatures per report
- 21 CFR Part 11 compatibility
- export files to PDF
- archiving: methods, results, storing/copying event logs to USB flash drive
- Meets EP/USP/JP and ASTM requirements
- printing: standard roll paper or network printer
- dimensions: 86 x 62 x 101 cm (W x D x H), weight when empty 118 kg, weight filled with water 174 kg.