Pharma Test PT-Studio is a new high-end control and data management software specifically designed by Pharma Test Germany for its full range of tablet hardness testers and multi-parameter physical property testers (including the PTB series, PTB 311E, PTB 420, PTB 500, and related connected equipment). The system integrates a modern, intuitive user interface, high-precision real-time data acquisition, and powerful statistical analysis functions, enabling comprehensive control over the multi-parameter testing process, including weight, thickness, diameter/length, width, and hardness (breaking force). This software strictly adheres to the International Pharmacopoeia standards USP <1217>, EP <2.9.8>, JP, and ChP, and fully complies with FDA 21 CFR Part 11 and ALCOA+ data integrity requirements, thoroughly realizing intelligent and paperless operations in pharmaceutical research and development (R&D), in-process control (IPC), and quality control laboratories (QC).

I. Intuitive operation and easy-to-use graphical interface that displays data in real time. It presents measured values and fracture curves in real time and automatically calculates the mean, standard deviation (SD), %RSD, and acceptance criteria.

II. Compliance with regulations, data integrity and tamper-proof. Fully compliant with FDA 21 CFR Part 11 and ALCOA+. Features multi-level account permissions, electronic signatures, encrypted databases, and a complete audit trail.

III. Flexible approach, easy integration with LIMS: Supports unlimited creation of test methods, built-in SPC control charts and multi-batch trend analysis; can export PDF reports or CSV/XML with one click, seamlessly integrating with LIMS systems.

Software Introduction

• Fully automated hardware control and multi-parameter synchronous testing.

  • Remote Bidirectional Communication & Seamless Hardware Integration : Seamlessly connects the Pharma Test PTB series (PTB 111E, PTB 311E, PTB 420, PTB 500) and external high-precision analytical balances (such as Mettler Toledo and Sartorius) via RS-232, USB, or PT-Node network modules. The software can directly start the test and simultaneously capture five physical parameters: weight, thickness, diameter/length, width, and hardness.

  • Multiple Breaking Modes & Intelligent Parameter Configuration : Fully supports Linear Force Increase (LFI: 5–200 N/s) and Linear Speed Increase (LSI: 0.1–3.0 mm/s) modes, and can flexibly switch the breakage threshold and sensing sensitivity according to different dosage forms and special geometric shapes (round, rectangular, irregularly shaped tablets).

• Real-Time Dynamic Breaking Curve & Visual Monitoring

  • Real-Time Force-Displacement/Time Dynamic Curve Tracing : The software's main screen displays a high-resolution real-time dynamic curve of each tablet as it is compressed and fractures, accurately capturing the initial contact point, plastic deformation zone, and peak force, providing an intuitive view of the tablet's physical and mechanical properties.

  • Live Statistical Calculation & Instant Pass/Fail Evaluation : During the test, the mean, standard deviation (SD), relative standard deviation (%RSD), maximum value (Max), and minimum value (Min) are automatically and synchronously calculated. Combined with T1/T2 warnings and tolerance limits, the pass/fail status is determined in real time using color warnings.

• Modular Method Library & Batch Statistical Trend Analysis

  • Flexible Method Management & Quick-Start Workflow : Supports unlimited test method creation and quick loading. Users can predefine sample specifications, tolerance range, batch number, number of test pieces (1–100 tablets/batch), and operating parameters, along with intuitive graphical guidance to simplify daily testing processes.

  • SPC Quality Control & Multi-Batch Comparison Analysis : Built-in powerful SPC control charts (X-bar / R-chart), normal distribution histograms, and multi-batch trend comparison modules can generate graphical and textual standard validity and quality reports that comply with the specifications of various pharmacopoeias (USP <1217>, EP <2.9.8>, JP, ChP) with one click, and support seamless integration with enterprise LIMS / ELN systems in PDF, CSV, and XML formats.

• Fully compliant with FDA 21 CFR Part 11 and GLP Data Integrity Compliance

  • Strict user access control and electronic signature management : Features multi-level access control for system administrators, supervisors, and operators, supports a two-person electronic signature (Review & Approve) authorization release mechanism, and testing or modification methods cannot be started without identity verification.

  • Tamper-proof Encrypted Database & Comprehensive Audit Trail : All test data, correction records, and operational processes are stored in an encrypted relational database; a built-in, tamper-proof, real-time audit trail meticulously records "people, events, time, location, before/after values, and reasons for changes," fully complying with the highest principles of ALCOA+ data integrity.