The Pharma Test PTBA 211E Dual Tablet Hardness & Ampoule Breaking Force Tester is designed for manufacturers of injectable ampoules, sterile injection preparation plants, quality control (QC), process control (IPC), and drug development. This instrument innovatively integrates ampoule breaking force testing and standard tablet breaking force testing into a single machine, fully complying with DIN EN ISO 9187-1, DIN EN ISO 9187-2, and DIN 58366 ampoule standards, as well as the United States Pharmacopeia (USP) <1217> and European Pharmacopeia (EP) <2.9.8> standards for tablet hardness testing.

I. Supports a two-in-one fully automatic measurement function, which can accurately measure the ampoule breaking force and the tablet breaking force/hardness.

II. Equipped with a patented quick-replacement ampoule positioning holder and blade clamp, suitable for point-cut, color-break, and ring-cut ampoules of various sizes from 1 mL to 30 mL.

III. It features a dual force application mode of linear force increase (LFI) and linear constant velocity increase (LSI), and adopts a highly sensitive strain gauge load cell and microprocessor step drive to completely eliminate subjective errors caused by human breakage.

IV. Built-in automatic calibration and verification procedures, supporting RS-232 data output, standard report printing and PT-Node LAN IoT conversion, fully compliant with GMP and 21 CFR Part 11 data integrity requirements.

Equipment Introduction

• Dual-Application Testing: Ampoules & Tablets

  • Dual-function integrated design: It has dual testing capabilities for ampoule breaking force and tablet hardness, and can quickly change test fixtures and sample holders in just a few seconds without tools.

  • Comprehensive fracture force assessment: Accurately captures the maximum peak force at the moment of sample fracture, providing key physical property data for the fragility, opening safety, and mechanical strength of injectable ampoules.

• Dedicated Ampoule Testing Adapters & Holders

  • Modular ampoule positioning kit: Provides a dedicated stainless steel support bracket and test blade, covering ampoule sizes from 1 mL, 2 mL, 5 mL, 10 mL, 20 mL to 30 mL.

  • Standard force angle and position correction: Strictly follows the DIN ISO standard for lever breakage geometric center positioning, completely eliminating the problem of poor data reproducibility caused by manual force application angle deviation.

• Dual Force Application Modes & Precision Load Cell

  • Highly sensitive load sensing: The machine body has a built-in precision strain gauge load cell with an accuracy better than ±1 N and a resolution of 0.1 N.

  • Flexible force control: It features a linear force increase mode (LFI: 5 to 200 N/s) and a constant speed increase mode (LSI: 5 to 200 mm/min), perfectly adaptable to ampoules of different wall thicknesses and various hardness tablets.

• It fully complies with international standards and the pharmacopoeias and regulations of various countries (Global Pharmacopeia & International Compliance).

  • Ampoules are internationally compliant: fully compliant with DIN EN ISO 9187-1 (Injection Ampoule Specifications), DIN EN ISO 9187-2 (One-Point-Cut Ampoule Breaking Force Test) and DIN 58366.

  • Pharmacopoeia tablet hardness standards: fully compliant with the physical property testing standards for solid preparations in the United States Pharmacopeia (USP) <1217>, the European Pharmacopoeia (EP) <2.9.8>, the Japanese Pharmacopoeia (JP), and the Chinese Pharmacopoeia (ChP).

• Integrated Calibration & Dynamic Qualification System

  • Built-in calibration program: Supports digital menu-guided calibration of load cell, two-point adjustment of static weights (0 and 10 kg) and multi-point standard weight verification (can be used with PTB-CAL15/30 kit).

  • Dynamic validation compatibility: Fully compatible with the Pharma Test PT-MT3 dynamic magnetic simulation tablet system, enabling periodic verification of the instrument's fracture point detection sensitivity and force linearity.

• Compliance with Laws and Regulations and Data Management (Data Integrity & Printing Capabilities)

  • Security access control: System date, time, calibration cycle, test parameters and force application mode are all password protected to prevent unauthorized tampering.

  • Report output and network transmission: Standard RS-232 transmission interface and parallel printer port, supporting external document/A4 printers, and can be expanded to connect directly to the LAN (LAN/Wi-Fi) with PT-Node network adapter to realize paperless data integration of LIMS system.