The Pharma Test WHT 4 fully automated high-throughput tablet physical property testing system is designed for pharmaceutical production process control (IPC), online quality monitoring, and quality control (QC) laboratories. It can be used for fully automated, unattended multi-parameter physical testing of tablets, capsules, and various irregularly shaped compressed tablets. This instrument fully complies with international standards and specifications such as the United States Pharmacopeia (USP) <1217>, the European Pharmacopoeia (EP) <2.9.8>, the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP).

I. Supports standard four-in-one or optional five-in-one fully automatic measurement functions, which can accurately measure the weight, thickness, diameter/length, width and hardness of tablets.

II. Equipped with a patented multi-claw automatic sample rotation and orientation clamping mechanism, it can automatically and actively align round, elongated elliptical, capsule-shaped and various geometric irregularly shaped tablets, completely eliminating measurement errors caused by sample placement skew.

III. Supports optional 10-slot carousel autosampler, or direct connection to mainstream tablet presses to achieve fully automated online timed sampling and real-time closed-loop feedback control.

IV. It adopts stepper motor drive and supports dual destruction modes of "linear force" and "linear velocity". It is centrally controlled by dedicated WHT32 software and has real-time SPC statistical charts, multi-level user permission control and tamper-proof audit trail function, fully complying with GMP and 21 CFR Part 11 data integrity regulations.

Equipment Introduction

• Fully Automated High-Throughput Multi-Parameter Physical Property Testing System

  • 4-in-1 / 5-in-1 All-Parameter One-Stop Testing : Integrates fully automated continuous measurement of weight, thickness, diameter/length, width (optional) and hardness, and completes comprehensive physical testing with a single sample injection.

  • Unmanned, high-throughput, continuous operation : specially designed for mass production process control (IPC) and quality control laboratories, significantly shortening the testing cycle and completely eliminating operational errors from manual testing.

• Patented Tablet Orientation & Alignment Mechanism

  • Active rotation alignment and clamping mechanism : Equipped with a unique multi-jaw automatic orientation rotation mechanism, it accurately aligns round, elliptical, capsule-shaped and various polygonal irregular tablets.

  • Secondary precise measurement of length and width of irregularly shaped tablets : The sample can be actively rotated 90° in the testing station to accurately measure the major and minor axis dimensions of the irregularly shaped sample, eliminating the force deviation caused by skewed placement.

• Multi-feeding architecture integrated with in-line tablet press connection (Flexible Feeding & In-Line Tablet Press Connection)

  • Online closed-loop sampling and control of tablet press : Supports standardized online transmission interface, which can be directly connected to tablet presses of major brands to realize automatic timed and fixed-line online sampling and closed-loop feedback control.

  • Multi-slot automatic rotary sampler : Optional 10-slot rotary sampler (Carousel) supports unattended scheduling and continuous testing of multiple batches of samples of different specifications.

• Pharmacopoeia Dual Force Modes & Precision Stepper Drive

  • Linear force and linear speed loading control : It has two pharmacopoeia standard destruction modes: "Linear Force Increase (LFI)" and "Linear Speed Increase (LSI)".

  • High-resolution stepper motor drive and fracture detection : A precision stepper motor is used in conjunction with a high-sensitivity force sensor and a real-time microprocessor to accurately capture the initial fracture point and the peak value of the fracture at the end of the sample.

• WHT32 Professional Control Software and SPC Statistical Analysis

  • Real-time statistical analysis of process control and dynamic charts : The dedicated WHT32 software provides comprehensive control and generates SPC statistical charts such as histograms, X-bar/R dynamic control charts, and coefficient of variation (%RSD) in real time.

  • Real-time exceedance warnings and batch report export : It has the ability to set custom T1/T2 alert and action control limits, and will immediately issue an alarm when exceeding the limit and automatically generate a compliant electronic batch analysis report.

• Complies with the International Pharmacopeia and data integrity regulations (Global Pharmacopeia & 21 CFR Part 11 Compliance).

  • Fully compatible with global pharmacopoeia testing regulations : fully compliant with USP <1217>, European Pharmacopoeia EP <2.9.8>, Japanese Pharmacopoeia JP, British Pharmacopoeia BP, and Chinese Pharmacopoeia ChP, etc.

  • Compliant with FDA 21 CFR Part 11 and GMP audits : Built-in multi-level user access control, tamper-proof audit trails and electronic signatures, and compliant with ALCOA+ data integrity requirements.

Software Introduction

• WHT32 Professional Control and Data Analysis System (Fully Automated Tablet Physical Property Testing Software):

  • User-Friendly GUI: Adopts a professional control interface based on Windows architecture, with full-process graphical guidance, supporting the rapid creation, saving and one-click recall of multiple product recipes (methods).

  • Real-Time Monitoring: During the inspection process, the weight, thickness, diameter, width, and hardness of each tablet are displayed in real time, along with the fracture stress curve.

• Statistical Process Control and Quality Analysis (SPC & Statistical Analysis):

  • Dynamic Control Chart Generation (SPC Charting): The system automatically and in real-time generates histograms, normal distribution curves, trend charts, and X-bar/R dynamic control charts.

  • Automatic Statistical Calculations: Automatically calculates complete statistical parameters such as mean, standard deviation, coefficient of variation (%RSD), maximum value, and minimum value.

  • Two-tiered control limit alarms (T1 / T2 Alert & Action Limits): Supports custom product alert limits (T1) and action limits (T2). When data exceeds the limits, the system will immediately trigger visual alarms and warning signs.

• In-Line Process & Automation:

  • Tablet Press Feedback Loop: Supports two-way communication with mainstream tablet press brands (Fette, Korsch, Kilian, etc.), and automatically sends back compensation signals based on the test results to control the tablet pressing process.

  • Carousel Batch Queuing: When used with a 10-slot rotary sampler, it can pre-program test sequences of different batches and specifications to achieve unattended, continuous, and fully automated testing.

• Data Integrity and Compliance:

  • Electronic Records and Electronic Signatures (21 CFR Part 11 & Annex 11): Features multi-level user access control (system administrator, quality assurance supervisor, inspection analyst, etc.), supports password complexity, automatic logout upon inactivity, and electronic signature approval processes.

  • Unalterable Audit Trail: Automatically and meticulously records all operational events, parameter modifications, calibration processes, and inspection records, with timestamps and operator identification, complying with the ALCOA+ data integrity principle.

  • Compliant Batch Reporting: One-click generation of standardized, tamper-proof PDF batch analysis reports and raw data, supporting automatic export and integration with LIMS/ERP systems.