Disintegration Tester EDI-3X

Introduction

In the rigorous world of pharmaceutical quality control, the accuracy and efficiency of disintegration testing are paramount. This critical process ensures that solid dosage forms like tablets and capsules break down within the prescribed time when exposed to fluid. The Disintegration Tester EDI-3X from Electrolab emerges as a state-of-the-art solution, meticulously engineered to meet these demands. It combines innovative technology with user-centric design to streamline laboratory workflows.

The standout feature of the EDI-3X is its advanced bathless heating system, which eliminates the need for a traditional water bath, saving time, energy, and maintenance efforts. With three independent testing stations, it significantly boosts productivity by allowing simultaneous, separate tests. Fully compliant with major pharmacopeias including USP, IP, and Ph. Eur., the Disintegration Tester EDI-3X is not just a piece of equipment; it’s a guarantee of precision, reliability, and regulatory adherence for any modern pharmaceutical laboratory.

Product overview

The Disintegration Tester EDI-3X is a sophisticated laboratory instrument designed for accurately determining the disintegration time of solid dosage forms. Its robust construction, available in either stainless steel (S.S.) or mild steel (M.S.), ensures durability and longevity in demanding lab environments. The device operates three separate testing stations, each equipped with its own motor, timer, and temperature probe, offering unparalleled flexibility and throughput.

At its core, the EDI-3X is built for compliance and ease of use. The unique camless drive system ensures a smooth, reliable stroke movement, while the magnetically coupled baskets make loading and cleaning effortless. With features like bottom illumination for clear visibility and a direct report printing function, the EDI-3X simplifies the entire testing process, from setup to documentation.

Key features & benefits

The Disintegration Tester EDI-3X is packed with features designed to enhance efficiency, compliance, and user experience.

• Advanced bathless heating: The innovative bathless design uses efficient heater plates to warm the media directly. This results in faster heating, significant savings on electricity and water, and completely maintenance-free operation compared to conventional water baths.

• Independent 3-station operation: Each of the three stations functions independently with its own motor, timer, and external temperature probe. This allows technicians to run three different samples or protocols simultaneously, maximizing lab productivity.

• Full pharmacopeia compliance: The instrument is designed to be fully compliant with USP, IP, and Ph. Eur. specifications, ensuring that all test results meet global regulatory standards for pharmaceutical testing.

• Unique camless drive: This special drive mechanism provides a consistent and precise 30 strokes per minute, minimizing vibration and mechanical wear for long-term reliability and quiet operation.

• Ergonomic and user-friendly design: Baskets are magnetically coupled for snap-click loading and are swivel-free, simplifying handling. The unit also features bottom illumination with a green LED for a clearer view of the disintegration process.

• Integrated data and reporting: A built-in serial port allows for easy printing of test results and validation reports. The system can store up to 10 different protocols and features a security system to protect data integrity.

Technical specifications

Use cases and applications

The Disintegration Tester EDI-3X is an essential tool for quality control and research & development departments in the pharmaceutical industry. Its primary application is to test the disintegration properties of:

• Standard compressed tablets

• Coated and uncoated tablets

• Hard and soft gelatin capsules

With optional accessories, its capabilities can be extended to test specialized dosage forms such as large bolus tablets or isotretinoin soft gel capsules, making it a versatile instrument for a wide range of oral drug products.

Pricing and availability

The Disintegration Tester EDI-3X is currently in stock and available for order. For pricing details, please use the “Add to Quote Cart” feature on the product page.

Several models are available to suit different laboratory needs and power standards:

• 0241600: EDI-3X (Body made of S.S.) – 230V

• 0221600: EDI-3X (Body made of M.S.) – 230V

• 0211600: EDI-3X (Body made of S.S.) – 110V

• 0231600: EDI-3X (Body made of M.S.) – 110V

The standard package includes the main unit, three 6-tube basket assemblies, three 1000 ml glass beakers, and three external temperature probes. Optional accessories like specialized baskets and Connexion+ software are also available.

Frequently asked questions (FAQ)

1. What pharmacopeial standards does the EDI-3X comply with?
The EDI-3X is fully compliant with the latest specifications from United States Pharmacopeia (USP), Indian Pharmacopoeia (IP), and European Pharmacopoeia (Ph. Eur.).

2. What is the main advantage of a “bathless” disintegration tester?
The primary advantage is that it is maintenance-free. It also heats up faster, consumes less electricity, saves water, and eliminates the hassle and potential for contamination associated with traditional water baths.

3. Can I run different tests on the three stations at the same time?
Yes. Each of the three stations operates independently with its own motor, timer, and temperature control, allowing you to run three separate and distinct tests simultaneously.

4. What materials are available for the body of the EDI-3X?
The EDI-3X is available with a body made of either high-grade Stainless Steel (S.S.) for maximum chemical resistance or durable Mild Steel (M.S.).

5. How can I get a report of my test results?
The device is equipped with a serial port that allows you to connect a printer and generate detailed reports of your test results and validation data directly from the instrument.

6. What accessories are included with the standard purchase of an EDI-3X?
The standard purchase includes three 6-tube basket assemblies, three 1000 ml glass beakers, and three external temperature probes.

7. Is the EDI-3X suitable for testing specialized capsules?
Yes, with the appropriate optional accessories, the EDI-3X can be configured to test specialized dosage forms, including isotretinoin soft gel capsules and single or three-tube bolus tablets.

Conclusion

The Disintegration Tester EDI-3X stands out as a superior choice for any pharmaceutical laboratory focused on efficiency, accuracy, and regulatory compliance. Its innovative bathless heating, independent three-station design, and user-friendly features address the key challenges of modern disintegration testing. By eliminating maintenance, saving resources, and increasing throughput, the EDI-3X provides a significant return on investment.