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 manufactured 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 AutoMag already known with the Vision instruments facilitates the automatic tablet drop and the use of temperature sensors (12-position) per vessel immersed in the medium during the measurement. 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. Unlimited expansion of the data to be stored is possible with the use of the Protocol Manager software. The methods can be written and copied onto the instrument with this software and all the performed tests and and all the information in connection with the instrument will be stored in the database of the computer/server automatically.
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 and 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.
2 CD AutoPlus Dissoscan or 2 CD AutoPlus Maximizer syringe pump samplers can automatically take samples from the 2×6 test vessels of the CD14 dissolution tester. The sampling probes are located on two independently moving AutoMags. The AutoMag, together with the temperature sensors, immerses the 1/8” PEEK sampling probes in the dissolution medium only during sampling or temperature measurement. The immersion depth can be adjusted by means of software for medium volumes of 1000-450 ml. The samples can be filtered with tip filters and with syringe filters optionally placed in the liquid path, and then can be collected in HPLC vessels or test tubes.
The dissolution test method is written with the internal software of the CD14, during the operation all the modules are controlled by the CD14. Since the CD Disscoscan has 2 fluid paths, it can only be used for sampling and fraction collection. The CD Maximizer equipped with 4 liquid paths, in addition to the previously mentioned functions, can also be used for medium replenishment and automatic washing at the end of the test. The already proven AutoFill sample collector for the Elite8 and Classic6 systems is used to collect the samples.
The 12-place test methods launched on CD14 ensures the simultaneous operation of both samplers, from the simultaneous drop of 12 tablets to the results appearing in the report. Due to the independently moving stirring elements, AutoMags, samplers and sample collectors of the 6-6 test vessels, it is possible to perform 2 completely independent dissolution tests simultaneously and automatically.
- minimum sampling interval: 5 minutes
- standard syringe volume: 10 ml
- sample volume 0.5 – 15 ml
- sampling accuracy ± 1%
- rack types:
- 16 x 100 mm tube, 8 x 18 positions
- 12 x 32 mm vial, 8 x 21 positions
- control: via color touch screen with diagnostics and manual control functions
- method writing: through the touch screen of the CD14 dissolution bath
- number of programmable samples: 1 – 50
- dimensions: AutoPlus: 47x38x66 cm, 21 kg; AutoFill: 40x28x47 cm, 15 kg (L x W x D).