DISI-2A Automatic Disintegration Tester

DISI-2A Automatic Tablet Disintegration Tester:

The DISI-2A Disintegration Tester is a reliable, high-performance instrument designed for automated testing of tablet disintegration in pharmaceutical quality control laboratories. This system is ideal for evaluating up to four different products simultaneously, offering enhanced flexibility and efficiency for regulated testing environments.

Key Features & Functionality

• Independent Testing Stations
  Each of the four test stations operates independently, allowing simultaneous disintegration testing of up to four tablet or capsule formulations.

• Controlled Immersion with Soft Start
  The soft-start function ensures smooth immersion of the testing baskets into the dissolution media, minimizing turbulence and ensuring accurate, repeatable test conditions.

• Sinusoidal Basket Motion
  The baskets utilize stepping motors in micro-step mode to produce consistent, sinusoidal up-and-down movements. This ensures precise replication of standard disintegration conditions across all stations.

Advanced System Operation with PH21 Software

The DISI-2A is fully operated through the Windows-based PH21 software, which provides an intuitive interface for test setup, execution, and reporting. The software meets FDA 21 CFR Part 11 compliance, including features such as:

• Password-protected user access

• Configurable access levels

• Comprehensive audit trail with timestamped logs

• Data integrity and traceability

Real-Time Disintegration Monitoring

The system offers continuous tablet height indication throughout testing. Operators receive instant alerts if tablets fail to disintegrate within the specified time limits. This enables immediate decision-making and documentation of out-of-specification results.

Electromagnetic Height Measurement Technology

The DISI-2A uses a patented electromagnetic measurement principle for non-contact sensing of tablet height. Key components include:

• Six embedded electromagnetic coils in the basket’s lower plate

• Signal processing circuits are sealed in the base for durability

• Copper rings in the discs that modulate the electromagnetic field

This method provides accurate and maintenance-free measurement unaffected by corrosion or debris, a common issue in traditional testers.

Baskets and Handling

• Magnetic Coupling: Baskets attach and detach quickly without cables.

• Easy Disassembly: Components can be fully submerged for thorough cleaning.

• Clear Design: Transparent structure allows unobstructed visual inspection.

• Quick-Lock System: Prevents loss of disintegration discs during testing.

Precision Temperature Control

Each basket is monitored by an individual temperature sensor. A thermostatic water bath ensures the immersion fluid remains within strict limits. Any temperature deviation automatically triggers alarms and halts the test to protect data integrity.

Robust Data Analysis & Reporting

With PH21 software integration, all testing data is stored securely and traceable to the batch and test number. Features include:

• Real-time graphical data display

• Tabular summaries and batch statistics

• Printable reports for individual tests or cumulative analysis

Applications

The DISI-2A Disintegration Tester is ideal for:

• Pharmaceutical tablet and capsule disintegration testing

• GMP/GLP-compliant laboratories

• Research and development

• Quality assurance and quality control environments