Single-Basket Disintegration Tester

What is the Single-Basket Disintegration Tester?

A single-basket disintegration tester moves one six-tube basket-rack assembly through a heated bath at pharmacopoeial stroke and frequency. It is the standard choice for routine release testing of uncoated and film-coated tablets and capsules.

Overview

The single-basket design carries one basket-rack assembly with six glass tubes, a stainless steel mesh screen, and a 1 L beaker for the immersion fluid placed in a thermostatic water bath. A motor and crank mechanism produce a vertical stroke of 55 ± 2 mm at about 30 cycles per minute. A digital controller sets the test time and bath temperature, and sounds an alarm at the end. Because there is only one basket, all six units undergo the same conditions, which suits batch release. The design is simple and inexpensive, easy to clean, and quickly verified. The limitation is throughput, because staged or paired testing needs sequential runs. Some models have a lift-out mechanism so that the basket can be raised and inspected without removing the beaker.

How does it work?

A disintegration tester consists of a basket-rack assembly, a motor-driven mechanism, and a thermostatic bath. The basket-rack holds six transparent tubes with a stainless steel mesh (typically 2.0 mm aperture) at the bottom. The mechanism moves the assembly vertically through a distance of 53 to 57 mm at 29 to 32 cycles per minute, while the immersion fluid, usually water, 0.1 M hydrochloric acid or phosphate buffer, is held at 37 ± 2 °C. A dosage unit is placed in each tube, optionally with a perforated disc that adds gentle mechanical action. The test ends when no residue, other than fragments of insoluble coating or capsule shell, remains on the mesh. The operator records the time of complete disintegration, which is compared with the monograph limit, commonly 15 to 60 minutes.

What are the key features?

• One basket-rack with six tubes meeting pharmacopoeial dimensions
• Stroke of 55 mm at about 30 cycles per minute
• Digital temperature control of the water bath at 37 °C
• Test timer with audible end-point alarm
• Lift mechanism for easy inspection of the basket

What are the technical specifications?

A typical single-basket disintegration tester configuration offers number of baskets of 1, tubes per basket of 6, stroke length of 55 ± 2 mm, frequency of 29–32 cycles/min, mesh aperture of 2.0 mm and bath temperature range of Ambient +5 to 45 °C. Values are indicative of the product class; the exact figures for each configuration are confirmed on the quotation and the calibration documents supplied with the instrument.

Which applications is it used for?

The Single-Basket Disintegration Tester is used in routine tablet release testing, capsule testing, raw material tablet evaluation and teaching laboratories. Across the wider Disintegration Testers class, laboratories also deploy it for tablet and capsule release testing, formulation development and stability studies.

Which standards and certifications apply?

Relevant standards and methods include USP <701>, Ph. Eur. 2.9.1, JP 6.09 and IEC 61010-1. Certification candidates for this model are CE and ISO 9001 manufacturing; each is to be confirmed for the specific configuration before shipment, and certificates are supplied only where they have been issued.

Install the tester on a stable bench with a level water bath and access to clean water. Calibrate stroke length, frequency and temperature at installation and at defined intervals, using an independent thermometer and a ruler or gauge. Replace the immersion medium frequently and clean tubes, mesh and discs to prevent residue build-up that blocks the mesh. Use deaerated medium if required by the method, because air bubbles can lift tablets. Check the mesh for distortion, since a damaged screen changes the test outcome. Record lot numbers of medium, bath temperature and operator. Under GMP, document IQ, OQ and PQ, and verify the system with a suitable reference tablet where practical.

How do I select the right Single-Basket Disintegration Tester?

Choose a single-basket model for routine release where one group of six units is tested at a time. Move to a dual-basket model when staged or parallel testing is frequent. In an RFQ, specify stroke length, frequency, mesh aperture, bath temperature range and whether a disc or calibration certificate is required.

How does it compare with other Disintegration Testers variants?

Choose according to sample throughput, temperature control and data requirements. A two-basket tester allows two test groups in parallel and is often chosen where stage testing is performed, for example acid stage followed by buffer stage for enteric products. Single-basket units are adequate for routine release. Confirm stroke length, frequency and basket dimensions against the target pharmacopoeia, and check that the bath can hold 37 °C within ±1 °C. Automatic endpoint detection reduces subjectivity, which matters for opaque or colored dosage forms where visual judgment is difficult. Laboratories under GMP should look for software with audit trails and probe-based temperature recording. A portable or benchtop size matters if bench space is limited, and a bath with a cooling or sealed circulation option helps in warm climates.