Tablet Disintegration Tester DTG 100i Copley UK

Description

Tablet Disintegration Testers-DTG 100i Copley UK

Test Apparatus & Method of Tablet Disintegration

Before drug can dissolve into the blood stream, the tablet must first disintegrate into small particles.

Typically, the tablets and capsules to be tested are each 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 each tube is covered by a 2 mm sieve mesh. Large tablets, capsules and boluses may require a larger basket. The basket assembly is raised and lowered in in a vessel containing 1000 mL of simulated gastric fluid at body temperature (37 °C) through a distance  of 55 mm, at a constant stroke frequency of 30 cycles per minute. A plastic disc of precise geometry “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.

DTGi Compliance & Maintenance

• Certificate of compliance to Ph. Eur./USP provided as standard
• Comprehensive IQ/OQ/PQ documentation packages and toolkits available
• Passcode-protected single-point electronic temperature calibration
• Latest temperature calibration information stored and available to print/export

 

Reporting

Extensive data output options are available as standard, including direct reporting to a printer or PC.

Data reporting output options:

• USB A
• USB B
• RS 232

Available Reporting Parameters

• Speed (cycles per minute)
  – Set
  – Average
  – Maximum
  – Minimum

• Temperature (°C)
  – Set
  – Average
  – Maximum
  – Minimum

• Test Duration (HH:MM:SS)
  – Set
  – Actual

• Calibration Data
  – Calibration date
  – Temperature calibrated at (°C)

 

Temperature Calibration

 Single-point electronic temperature calibration. Calibration of the DTGi Series temperature probe is simple, through the use of an electronic calibration  key and passcode-protected calibration menu designed to guide users through the process without fuss. The latest temperature probe calibration information is stored and available to print/export when convenient to the use.

Independent Station Control: DTG 200i-IS

With the same standard features as the other DTGi systems, the DTG 200i-IS offers independent control over each test station, making it ideal for the following types of applications:

• Comparing one formulation directly against another
• Comparing the performance of a single formulation under different conditions
• Assessing delayed release or enteric coated tablets where samples must be immersed for specified periods of time in different media
• Allowing two users to run tests simultaneously

 

DTGi System Accessories

Complete range of accessories for use with the DTGi Series is available, from complete basket-rack assemblies to individual tubes, discs and sieve meshes. All parts are manufactured to tolerances that are equal to or better than those quoted in the respective Pharmacopoeias. Certificates of  compliance can be supplied upon request.

Pharmacopoeial Compliance:	Ph. Eur. 2.9.1 USP <701> and <2040>
User Interface	Resistive touchscreen
Basket Rack Assembly	Automatically lowered and raised at beginning and end of test run
Stroke Frequency Range	10 – 50 strokes/min
Stroke Height	55 ± 1 mm
Heater Type	Independent digital heater/circulator
Heater Temperature Range	Ambient – 50 °C
Test Run Time	Up to 99 hours , 59 minutes, 59 seconds
Alarm(s)	1. End of testing (audible) 2. Low bath water level warning on-screen indicator
Data Output	RS 232 USB A (for connection with a USB printer) USB B (for connection with a PC)

 

DTG 100i

Number of Test Stations:	1
Tablet Capacity:	Up to 6
Independent Station Control:	No
Unit Dimensions (w x d x h):	450 x 473 x 657 mm