Key Features of Automated Tablet Disintegration Testers

Modern automated disintegration testers are equipped with advanced features that enhance their functionality and user experience:​

• Compliance with International Standards: Adherence to USP, FDA, and other pharmacopoeia standards ensures that the testing process meets global regulatory requirements.​
• Automated Data Recording: The system automatically records disintegration times, reducing manual errors and ensuring data integrity.​
• User-Friendly Interface: A 7-inch touch screen provides an intuitive display, making it easier for operators to navigate and control the testing process.​
• Quick Release Basket & Auto-Parking: These features simplify the operation, allowing for easy handling and maintenance of the testing apparatus.​
• Online Stroke Validation: Ensures the accuracy of strokes per minute, which is critical for consistent testing results.​
• Safety Features: Includes bath illumination and inbuilt thermal cutoff to enhance operational safety.​
• External Temperature Probe: Allows for precise temperature validation, ensuring the testing environment remains within specified parameters.
• Connectivity Options: Equipped with an in-built thermal printer port and RS-232 interface for seamless data transfer and documentation.​
• Real-Time Clock & User Management: Features password protection for enhanced security and accommodates up to 150 users, complying with 21 CFR Part 11 requirements.​

Technical Specifications

Understanding the technical aspects of automated disintegration testers is essential for selecting the right equipment:​

• Temperature Range: Ambient to 50°C with an accuracy of ±0.3°C.​
• Timer Range: 00:00:01 to 99:59:59, allowing for flexible testing durations.​
• Stroke Rate: 30 strokes per minute with a 55mm stroke height, aligning with standard testing protocols.​
• Power Requirement: Operates on 230V AC ~ 50 Hz, 6 AMPS.​
• Data Storage: Capable of storing over 1500 reports and audit trails in an uneditable format, ensuring data integrity.​
• Heating System: Features fast heating with automatic test initiation upon reaching the required temperature.​

Benefits of Automated Disintegration Testing

Implementing automated disintegration testers offers several advantages:​

• Enhanced Efficiency: Automation reduces manual intervention, speeding up the testing process and increasing throughput.​
• Improved Accuracy: Automated systems minimize human error, ensuring consistent and reliable results.​
• Regulatory Compliance: Compliance with 21 CFR Part 11 and other standards ensures that the testing process meets regulatory requirements.​
• Data Integrity: Automated recording and secure data storage maintain the integrity of test results, which is critical for audits and quality control.​
• User Management: The ability to manage multiple user levels with password protection enhances security and accountability.​

Compliance with Regulatory Standards

Automated disintegration testers are designed to meet stringent regulatory standards:​

• USP Chapters <701> and <2040>: These chapters outline the requirements for disintegration testing of tablets and capsules, ensuring that the dosage forms disintegrate within specified time frames.​
• Ph.Eur. <2.9.1>: The European Pharmacopoeia provides guidelines for disintegration testing, ensuring consistency across European markets.​
• 21 CFR Part 11 Compliance: This regulation mandates the use of secure, computer-generated, time-stamped audit trails and electronic signatures, ensuring data integrity and security.​

Conclusion

Automated tablet disintegration testers are essential tools in the pharmaceutical industry, ensuring that oral dosage forms meet quality and efficacy standards. With advanced features, precise technical specifications, and compliance with international regulations, these instruments streamline the tablet testing process, enhance data integrity, and support regulatory compliance.​