The Bareiss Digi test II Gelomat is a highly advanced and customizable digital hardness tester widely used by prominent pharmaceutical, vitamin, and paintball businesses globally. It offers complete automation and modularity, making it a preferred choice in the industry. In the present era of linked and tightly controlled worldwide marketplaces, it is necessary to comply with ‘critical-to-quality’ characteristics to provide top-notch goods. These companies are utilizing our capsule hardness tester, the Digi Test II Gelomat, to ensure that faulty capsules do not make it to the market. This device applies a compressive force to the gelatin capsules, performing precise capsule hardness measurements to verify that they possess adequate wall strength to endure external pressures throughout manufacturing, storage, packaging, transportation, and consumer use.

Compliance and Standards

The Digi test II Gelomat ensures compliance with industry standards and regulations, including:

• ASTM D1415 compliance: Ensuring the hardness testing meets standard methods.
• ASTM D2240 standards: Providing accurate hardness measurement for elastomers.
• DIN ISO 48-2: Adhering to standardized methods for hardness testing of soft materials.
• DIN ISO 48-3: Complying with international standards for hardness measurement.
• ISO 48-4 compliance: Ensuring the device meets global hardness testing requirements.

Capsule Quality Assurance

The Bareiss Digi Test II Gelomat is integral to capsule resilience testing and pharmaceutical quality control by providing reliable gelatin capsule testing. This includes verifying the structural integrity of capsules to prevent defects from reaching the market, thus ensuring consumer safety and satisfaction. Equipped with hardness testing equipment, this modular hardness tester supports automated hardness measurement, ensuring consistency and precision. By maintaining strict compliance with the relevant Shore hardness test standards, this capsule hardness tester aids the pharmaceutical, vitamin, and paintball industries in producing high-quality products that meet rigorous quality assurance protocols.

Characteristics and Advantages:

1) User-Friendly: This automated shore hardness tester has an electronic device that displays user information, time, and measurement techniques. It also includes many setups automatically measures time, and detects the measurement range.

2) Mechanism: The measurement devices (0-20N & 0-2N) can be easily connected and used without complicated mechanisms. The measuring devices can be securely attached manually using the knurled nut, and the electronic unit can promptly identify the device after it is configured.

3) Complexity: Gelatin capsules of various forms can be readily examined utilizing a range of human and automated equipment.

4) The product complies with FDA regulations outlined in 21 CFR Part 11 and includes a validation report that meets the clients’ requirements.

Protocol:

1) The electronic device is turned on and the extra weights are placed on the pickup bracket to measure loads ranging from 0 to 20 N. No additional weight is needed to measure loads from 0 to 2 N.

2) The centrofix device is used on the supporting table for Gelatin capsules. Ensure that the centrofix is aligned parallel to the pick up bracket and secure it using the knurled screws.

3) To adjust the distance between the indenter and the centrofix, release the clamping lever of the pickup bracket and gently press down until a gap of up to 10 mm is achieved.

4) Loosen the counter nut and spin the knurled nut until the indenter is positioned at the exact center of the template.

5) To begin the measurement, the user must click the ‘Start’ button on the electronic unit. Subsequently, the measuring equipment will be automatically lowered into the capsule.

6) Upon reaching the triggered lift, the measuring gadget returns to its original position. The suggested elevation is 2.0 mm.

7) The displayed value is simultaneously sent via the interface.