DENCOM
Brand Introduction
Dencom Co., Ltd. (株式会社デンコム) , headquartered in Japan, is a leading professional manufacturer specializing in pharmaceutical quality control analysis, physical property testing, and high-end packaging auxiliary equipment.
In the Japanese and global pharmaceutical industry, Dencom is most renowned for its two core pillars: "Fully Automated Tablet Multi-Parameter Physical Property Tester (Fully Automated Hardness Tester)" and "PTP Blister Unpacking Machine and Packaging Integrity Inspection (CCIT) Leak Detection System." Dencom combines original German high-precision burst sensing technology with extremely precise Japanese automation mechanism design, aiming to provide a comprehensive solution for the development, quality control (QC), and process inspection (IPC) of solid dosage forms (OSD) that is free from human error, highly reproducible, and fully compliant with International Pharmacopoeia standards.
Core flagship product: Fully automated tablet multi-parameter physical property tester (fully automated hardness tester)
Core values
Dencom's fully automated hardness tester system is a high-end testing device developed specifically for high-throughput, unattended testing. Its core fracture force sensing module and measurement unit integrate top-tier precision technology from Pharma Test in Germany, coupled with Dencom's proprietary, highly reliable Japanese automated conveyor and intelligent rejection mechanism. It is currently widely used by over 53 leading Japanese and multinational pharmaceutical giants (including Takeda, Daiichi Sankyo, Chugai, Otsuka, Shionogi, Pfizer, Bayer, etc.), with a cumulative installation record of over 200 units.
Product direction
1. Four-in-one / Five-in-one automatic multi-parameter continuous measurement
A single workstation can automatically and continuously measure all physical dimensions and strength data of the same sample:
Weight : Integrates a high-precision analytical balance module (precision up to 0.1 mg) to automatically record and statistically analyze the individual weight of the sample.
Thickness : High linear displacement sensor for precise measurement of tablet height.
Diameter / Length : Automatically detects the outer diameter or maximum length axis of the sample.
Width : Automatic rotation measurement for irregularly shaped samples such as capsule tablets and elongated tablets.
Hardness / Breaking Force : Employs a German Pharma Test patented load cell and precision step drive, supporting linear force increase (LFI) or constant speed increase (LSI) modes. The measurement range covers conventional formulations to ultra-high hardness tablets, with an accuracy better than ±1 N.
2. Patented intelligent sample orientation guide mechanism (Orientation Flaps)
Traditional hardness testers often require changing to specialized fixtures when testing non-circular samples. Dencom's patented sample guide flipping mechanism automatically and precisely guides round, star-shaped, oblong/caplet, bullet-shaped, and various hard/soft capsules to the optimal stress axis for the burst test (such as tip-to-tip positioning) without requiring machine downtime or manual replacement of mold parts .
3. Patented three-channel independent waste discharge system
To completely eliminate cross-contamination, powder accumulation, and sample mixing, Dencom has developed a unique three-channel patented diversion mechanism:
Channel 1 (Special collection trough for micro powder in balance) : The trace amounts of micro powder that fall during the weighing process are collected directly without affecting the subsequent optical and force measurement mechanisms or disturbing the zero point of the balance.
Channel 2 (Good Product Broken Sample / Untested Sample Diversion Channel) : Automatic left and right switching, completely broken test residue is collected separately from unbroken good products (or set abnormal samples).
Channel 3 (Feed and Emptying Trough) : Real-time monitoring of the hopper's feeding status. If the sample adheres or there is an abnormality, it is immediately diverted to an independent material box to ensure that the testing process is not interrupted.
4. Highly flexible batch feeding system
Rotary multi-batch feeder : Standard configuration includes 12 batches of automatic feeding rotary tables (each batch has an independent dustproof and moisture-proof cover to prevent samples from being exposed to air and becoming damp and deteriorated); 10-batch or 20-batch configurations can also be customized according to laboratory throughput requirements.
Dedicated expanding screw feeder : Optional AISI 316 stainless steel enlarged screw guide groove, perfectly compatible with 00 large capsules or large-size tablets (diameter > 22 mm, thickness > 8 mm).
5. International regulatory certification and data integrity
It fully complies with global pharmacopoeia standards : USP <1217>, USP <2091>, EP 2.9.8, EP 2.9.5, JP 18 (Japanese Pharmacopoeia 18th Amendment), ChP 2020 (Chinese Pharmacopoeia) and Chinese Pharmacopoeia (TP 9).
Compliant with FDA 21 CFR Part 11 and ALCOA+ : The software features multi-level user access control, tamper-proof audit trail for complete audit tracking, and automatic statistical analysis (Mean, SD, %RSD, Min, Max, T1/T2 tolerance judgment), and supports direct export or integration with LIMS laboratory information management systems.
Other core products
1. PTP Bubble Wrapping Machine Series (Deblistering Machines / カプセル・飠剤除包機)
Non-destructive and minimal-damage recycling technology : High-speed automated peeling of PTP blister packs with poor printing, misalignment, or those subject to process inspection. The precise elastic push mechanism prevents tablet chipping, coating peeling, or capsule rupture, significantly reducing the waste of expensive APIs and finished products.
Covering the full range of production capacity : providing desktop manual/semi-automatic models for R&D QC, as well as fully automatic high-speed multi-channel continuous unpacking machines for production lines, fully supporting Alu/PVC and cold stamping Alu/Alu blister packs.
2. Non-Destructive Container Seal Integrity Leak Testers (CCIT)
Quantitative, non-destructive testing : Compliant with the latest USP <1207> and EU GMP Annex 1 specifications, employing high-sensitivity vacuum decay and differential pressure sensing technology.
Widely applicable to various packaging types : It replaces the traditional blue ink immersion method, providing accurate quantitative data on microleakage for PTP blister packs, vials, ampoules, and prefilled syringes (PFS), keeping the samples uncontaminated after testing.
Brand advantages
The ultimate craftsmanship that combines German and Japanese technologies : It perfectly combines Germany's extreme precision in physical property measurement (Pharma Test load and sensing unit) with Japan's top-notch automation and low failure rate mechanical engineering.
Highly endorsed by leading Japanese pharmaceutical companies : It has long been the first choice of Japanese pharmaceutical companies with extremely stringent quality requirements, such as Takeda and Daiichi Sankyo. Its fully automatic hardness tester is a market leader in terms of automation smoothness, compatibility with irregularly shaped tablets, and durability.
A complete validation support system : Compliant with cGMP and GAMP 5 guidelines, providing detailed original manufacturer DQ/IQ/OQ/PQ validation documentation and multi-point calibration standard fixtures to ensure that pharmaceutical companies can successfully pass the rigorous audits of PMDA, US FDA and EMA.
