The Dencom WHT-4mj Automated Tablet Physical Testing System is designed for pharmaceutical quality control (QC), process-to-process (PAT/IPC) and high-throughput R&D laboratories. It can be used to quickly, accurately and automatically measure a variety of key physical properties of various round tablets, irregularly shaped tablets, controlled-release microcapsules and hard capsules.

I. Fully compliant with international pharmacopoeia standards such as the United States Pharmacopeia (USP) <1217>, the European Pharmacopoeia (EP) <2.9.8>, the Japanese Pharmacopoeia (JP), and the British Pharmacopoeia (BP).

II. The system integrates a high-precision analytical balance, a precision optical micrometer, and a servo-driven hardness destruction module, enabling continuous automated detection of multiple parameters such as weight, thickness, diameter/length, width, and hardness in a four-in-one or five-in-one manner.

III. The equipment adopts a patented anti-jamming fine-tuning sample feeding mechanism and multi-claw robotic arm positioning technology, which can accurately align and orient various irregular samples; the hardness testing module supports dual destruction modes of "Linear Force" and "Linear Speed" to ensure that the data has extremely high sensitivity and reproducibility.

IV. The entire machine can be equipped with dedicated control software or integrated with a tablet press for online closed-loop feedback control. The system has built-in powerful statistical analysis, multi-level user access control and complete audit trail functions, fully complying with GMP and 21 CFR Part 11 data integrity regulations.

Equipment Introduction

• German Core Technology & Global Pharma Proven Track Record

  • German Original Core Modules & Precision Sensors : The core hardness fracture module and key high-precision sensors all use original core components from major German pharmaceutical testing equipment manufacturers, ensuring top-notch mechanical durability, high sensitivity, and long-term measurement stability.

  • Extensive track record with leading international pharmaceutical companies : It has been adopted by more than 53 leading Japanese pharmaceutical companies and international multinational corporations, including Takeda, Daiichi Sankyo, Chugai, Otsuka, Shionogi, Pfizer, and Bayer, with more than 200 sets of actual operation verifications.

• High-Throughput Multi-Parameter Physical Testing & Patented Flap Alignment

  • All-in-one fully automated continuous physical measurement (4-in-1 / 5-in-1) : Multiple physical parameters such as weight, thickness, diameter/width, and hardness can be measured simultaneously in a fully automated and continuous manner, significantly shortening the analysis cycle and sample testing time.

  • Patented Special Flap Orientation Mechanism for All Dosage Forms : This special flap positioning mechanism automatically and accurately positions round tablets, star tablets, oblong tablets, bullet-shaped tablets, and various capsules without the need for frequent fixture changes or additional accessory purchases.

• Patented 3-Way Waste Sorting Chutes & Powder Dust Protection

  • Channel 1: Balance Fine Powder Collector : This channel is located above the balance and collects fine powder particles after they are broken down. It effectively prevents dust from scattering and causing pollution, ensuring the long-term accuracy of the precision balance.

  • Channel 2: Intelligent Left-Right Diverter for Broken/Intact Samples : The left side automatically collects broken waste tablets, while the right side precisely collects unbroken or completed samples, effectively implementing sample grading and waste classification management.

  • Channel 3: Feed Hopper Sample Drop Detection Channel : Equipped with intelligent sample drop detection function, it automatically guides the sample to the collection box, completely reducing human error and the risk of jamming.

  • Hardness Fracture Anti-Scatter Shield : Equipped with a dedicated hardness fracture transparent shield to prevent fragments and dust from scattering when the tablet breaks, fully protecting the operation of the precision electronic balance sensing mechanism.

• Flexible High-Capacity Automated Feeding Modules

  • Standard 12-Batch Feeder with Individual Lids : The standard configuration includes a 12-batch feeder, with each feed slot featuring an independent cap design to effectively prevent cross-contamination and moisture absorption between samples; 10-batch or 20-batch feed modules can also be flexibly customized.

  • Optional 316 Stainless Steel Enlarged Spiral Feeder: An optional 316 stainless steel enlarged spiral feeder module is available, perfectly supporting the feeding needs of No. 00 capsules or large tablets with a diameter >22 mm and a thickness >8 mm, as well as special irregularly shaped tablets.

• Comprehensive Pharmacopeia & Regulatory Compliance

  • Full Compliance with Major Global Pharmacopoes: Fully compliant with the latest pharmacopoeia standards and specifications of various countries, including USP <1217>/<2091>, EP 2.9.8/2.9.5, JP 18 (Quality Deviation and Manufacturing Homogeneity), TP 9 (General Pharmacopoeia of China 5001), and ChP 2020 (General 0902).

Software Introduction

• Compliant with 21 CFR Part 11 and Smart LIMS Data Interconnection

  (21 CFR Part 11 Compliance & Smart LIMS Data Integration)

  • The software features hierarchical password management (Admin/Operator/Auditor) and an unalterable, complete audit trail.

  • Built-in SPC process control chart (X-bar R chart) for dynamic quality trend monitoring, self-diagnosis upon startup, and daily inspection functions.

  • Supports seamless automatic data push to LIMS, with a two-way verification mechanism for returning confirmation codes; provides RESTful API, OPC UA, RS-232C, and Ethernet network transmission.

  • The report format is flexible, and it can export encrypted PDF, CSV and TXT files with one click. It also supports customized input of additional parameters such as breakage, fragility and moisture.