Disintegration Tester

The Testers have been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets and gelatin capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeias.

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Introduction Disintegration Testers

Approximately two thirds of all medicines prescribed today take the form of solid dosage forms and half of these are tablets. These tablets comprise a mixture of active drug and other excipients, usually in powder form, pressed or compacted into a solid.

It has long been recognised that before a tablet/hard gelatin capsule can dissolve and hence allow the active drug to be absorbed into the body, it must first disintegrate into smaller particles.

The current test apparatus described in the Pharmacopoeia* was designed to provide a reproducible and standardised method of ensuring that disintegration had taken place. Each of the tablets to be tested is placed in one of six vertical tubes each measuring approx. 77.5 mm long x 21 mm inside diameter positioned in a circular basket arrangement. The lower end of the tubes is covered by a 2 mm sieve mesh.

The basket assembly is raised and lowered in simulated gastric fluid at body temperature (37 degrees Celsius) through a distance of 55 mm at a constant frequency of 30 cycles per minute. A plastic disc of defined proportions “hammers” the tablet during the operation, thus assisting in the disintegration process.

The tablet is said to pass the test providing that no tablet residue remains on the sieve mesh after the designated time, typically 30 minutes for ordinary tablets and 60 minutes for enteric coated tablets.

All Copley Tablet Disintegration Testers feature:

  • Sturdy, robust design, including novel “quick release” basket, one-piece water bath and independent heater/circulator
  • Simple, easy-to-use operation ensures that the number of operations required to perform a test are kept to a minimum
  • Full supporting documentation (including full IQ/OQ/PQ qualification documentation if required)
  • Special accessories available for hard/soft gelatin capsules and large tablets, capsules and boluses

The Disintegration Tester Series DTG is the result of over 50 years’ experience in the field of pharmaceutical testing.

The Testers have been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets and gelatin capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeias.

The series is available with one (DTG 1000), two (DTG 2000), three (DTG 3000) or four (DTG 4000) test stations. 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.

PHARMACOPOEIAL COMPLIANCE AND QUALIFICATION

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 qualified and (c) that both compliance and qualification are documented.

Copley offers a three tier approach to address these points:

• Certificate of Compliance to USP/ Ph.Eur.: Provided free of charge with each unit. This is a written statement that the product, by design, complies with the current pharmacopoeial specifications.

• Laser Numbering and Certification: Identification and measurement of critical components to provide documented verification of compliance with current pharmacopoeial specifications. Available as an optional service.

• IQ/OQ/PQ Qualification Documentation: Comprehensive documentation to guide the user through the installation, operating and performance checks of the equipment in its operating environment, using specified test protocols. This optional service provides a comprehensive record of the suitability of the equipment to perform its specified task, to be created and archived.

Please see the ordering information for further details on our verification and qualification services.

DESIGN AND CONSTRUCTION

All of the DTG series feature a robust all metal construction. The motor drive employed operates 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 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 novel “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 for rapid cleaning.

Another unique feature of the basket design is the use of thumb screws to hold the various components together.

This means that if it is necessary to disassemble the basket before cleaning, this can be done very quickly and without the use of any specialised tools.

A common problem associated with fabricated water baths, used for warming the media, is that of leaks.

This problem has now been eliminated through the use of a 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 digital heater/ circulator to an accuracy of +/- 0.25 degrees C. This has two advantages: firstly, it removes the necessity for priming and secondly, it can be removed for cleaning without dismantling the whole disintegration tester. A low water-level alarm indicator is built into the unit as standard.

OPERATION

Considerable attention was paid to the design of the DTG 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 9 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 the use of iced water. This is not the case with the DTG series. Available as an option, the electronic temperature calibration kit comprises two UKAS certified test keys (0 and 37 degrees C), which you simply plug into the PT100 socket to perform the calibration.

Dimensions (mm):

DTG 1000/2000 = 450 x 450 x 720 mm (w x d x h)

DTG 3000/4000 = 700 x 450 x 720 mm (w x d x h)

  • Speed range: 30 rpm ± 1
  • Stroke: 55 mm ± 1
  • Independent heater/circulator to an accuracy of ± 0.2oC: no priming and easy to remove
  • A low water-level alarm indicator
  • Test run times up to 99 hours 59 minutes 59 seconds
  • Temperature probe: PT 100
  • At the end of the test, the basket rack assemblies are automatically removed from the test media and an audible alarm alert s the user that the run is completed
  • Dimensions:
  1. DTG 1000/2000 (WxDxH): 450 mm x 450 mm x 720 mm
  2. DTG 3000/4000 (WxDxH): 700 mm x 450 mm x 720 mm

The DIS 6000 has been designed as a direct response to this problem. With a footprint of just 650 x 450 x 640 mm (w x d x h), the DIS 6000 is one of the most compact dissolution testers available on the market today.

The Dissolution Tester DIS 8000 represents the very latest in tablet testing technology. CNC production techniques combined with modern microprocessor design guarantees the highest standards of performance and reliability.

The Testers have been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets and gelatin capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeias.

Based on an original design by Roche, the friability tester has now become an accepted standard throughout the pharmaceutical industry for determining the resistance of uncoated tablets to the abrasion and shock experienced in manufacturing, packing and shipping operations.

Together with friability testing, the testing of a tablet’s hardness (or more correctly breaking force) plays a vital role in both product development and subsequent quality control.

The Delivered or Emitted Dose is the total amount of drug emitted from the inhaler device and hence available to the user.

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