TABLET DISINTEGRATION TESTERS
The Disintegration Tester Series DTG is the result of over 50 years experience in the field of pharmaceutical testing.
It has been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets and gelatine capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeia.
Model DTG 1000 (1 Station)
Model DTG 2000 (2 Station)
The Series is available with one (DTG 1000), two (DTG 2000), three (DTG 3000) or four (DTG 4000) test stations, dual individual DTG2000IS also available (details on request). Each individual test station is capable of accepting one batch of six tablets or capsules.
Foremost in the design specification were those features that you, the user, identified as being essential to the ‘ideal’ Disintegration Tester:
Model DTG 3000 (3 Station)
Model DTG 4000 (4 Station)
PHARMACOPOEIAL COMPLIANCE AND VALIDATION
The most critical factors in the design of any Disintegration Tester are (a) that it complies with the respective Pharmacopoeia, (b) that this compliance can be proved or validated, and (c) that both compliance and validation can be documented.
Antech offer a three tier approach to address these points:
- Each Disintegration Tester is individually checked by our quality control department and provided with a Certificate of Compliance prior to dispatch. This states that the tester complies with the respective Pharmacopoeia by design and is free of charge.
- On request, certain critical components can be numbered and certified. The certificate provided includes the actual measurements relating to that component, along with details of the metrology equipment used and their traceability.
- IQ/OQ Documentation provides the necessary Standard Operating Procedures (SOPs) to guide you through the installation and operation qualification process. Alternatively, if you prefer, we or our official agent can often undertake this work for you.
DESIGN AND CONSTRUCTION
All of the series feature a central motor drive operating at a fixed speed of 30 rpm (+/- 1) and a stroke of 55 mm (+/- 1).
Depending on the model, the DTG has the capacity of testing up to one, two, three or four different tablet batches of six tablets/capsules simultaneously under identical test conditions.
The control of all models is provided by a membrane keypad linked to a 4-line 20 character back-lit LCD screen which together with the electronics is mounted in the head of the instrument so as to avoid any accidental spillages in the test area.
Particular attention has been given to the design of the basket rack assembly in respect of its removal and cleaning. The all-new ‘quick-release’ basket design not only provides a firm and rigid location for the basket during operation but also allows the basket to be removed from the instrument and placed in the dishwasher literally in seconds.
Another unique feature of the new basket design is the use of thumb screws to hold the various components together. This means that if you do prefer to disassemble the basket before cleaning, this can be done very quickly and without the use of any specialised tooling.
A common problem associated with the fabricated water baths used for the prewarming solution in the past was that of leaks. This problem has now been eliminated by moving over to a new one-piece water bath vacuum formed in rigid PETG. This construction not only eliminates any possibility of leaks but also makes it far easier to clean because of its rounded corners. The bath is fitted with a sturdy 8 mm clear view lid and secured to the base by four easily removed thumb screws.
The temperature of the warming solution is controlled by means of an independent heater/circulator to an accuracy of +/- 0.2 degrees C. This has two advantages: firstly, it removes the necessity for priming and secondly, it can be removed and if necessary, replaced in the event of maintenance without dismantling the whole disintegration tester. A low-water level alarm indicator is built into the unit as standard.
Considerable attention was given in the design of the series to ensure that the number of actions necessary to perform a test are kept to a minimum.
The membrane keypad allows for the selection of test run times up to 99 hours 59 minutes 59 seconds. Thereafter, it is only necessary to press the START key to automatically lower the basket rack assemblies into the test media and begin or repeat a test.
During the test, the time elapsed from the start of the test (or if you prefer, time remaining to the end of the test) is displayed on the LCD screen.
At the end of the test, the basket rack assemblies are automatically removed from the test media and an audible alarm alerts the user that the run is completed.
Bath and beaker temperatures can be constantly monitored using the PT100 temperature probe provided for this purpose. Temperature is critical to the test and is displayed permanently on the LCD screen as soon as the unit is switched on.
Ordinarily, temperature calibration can prove to be a time consuming and inaccurate process involving iced water, etc. Not so with the DTG. Available as an option, the electronic temperature calibration kit comprises two UKAS certified test caps (0 and 37 degrees C) which you simply plug into the PT100 socket to perform the calibration.
As already stated, the series offers the user an unparalleled number of standard features when compared with comparable units including:
- 99 Hour test programme permits delayed release as well as normal testing
- Acoustic signal at the end of the test
- Conforms to all current EP and USP specifications
- Choice of 1, 2, 3 or 4 test baskets
- ‘Quick-Release’ basket design combines stability with easy removal
- Automatically lowers and raises the baskets at the start and finish of the test
- Easy-to-clean vacuum formed water bath eradicates leaks
- Independent heater/circulator – no priming – easy to replace
- Low liquid level sensor
- Membrane control panel – easy to use
- PT100 Temperature sensor as standard
- Constant monitoring of time and temperature via LCD screen
- Electronic temperature calibration kit (optional)
- Certification and IQ/OQ Documentation Packs available (optional)
DTG 1000/2000 = 450 mm (W) x 450 mm (D) x 720 mm (H)
DTG 3000/4000 = 700 mm (W) x 450 mm (D) x 720 mm (H)