Huxley Bertram HB100 High Speed Tablet Compaction Simulator

Huxley Bertram’s HB100 high-speed Tablet Compaction Simulator allows highly potent compounds to be analysed for powder compaction properties during the drug formulation and development stage. In high containment mode, the HB100 allows development using highly active compounds.

The HB100 machine Is a high-speed servo-hydraulic tablet development press that can be used to simulate production presses at up to 1m/s punch speeds, simulating for example a Korsch XL800 running at 90rpm.

Flexible and configurable

The HB100 is a stand-alone system with containment, hydraulic, cooling and control systems all fully integrated, along with on-board tablet weight, thickness and breaking strength measurement instrumentation. The configurable work space can be used for tablet compaction, tri-axial, and other tablet physical properties tests.

The platform also includes a vacuum system with integrated filters and cyclone for powder recovery.

The HB100 can be specified with 50KN or 100kN dynamic capacity, operating at up to 130KN at slower speeds. The platform is designed to accommodate tri-axial Hiestand testing options and all standard tooling formats, including deep dies, micro-tablets, multi-tips etc. It can be specified with up to three programmable feeders for multi-layer, dry encapsulation or die lubrication options.

Full instrumentation

The HB100 instrumentation includes Huxley Bertram’s proprietary Powder Compaction Software package that enables a wide series of easily accessed simulation modes incorporating an extensive and editable library of commercial production presses and roller compactors, including GEA load relieving presses.

In Research Mode, the software allows fully flexible test sequence building with load or position-controlled tests. Easy test set-up screens allow a very wide range of accessories to be used in testing and “pop-up” help notes guide users through test set-up.

The software is compatible with electronic lab notes systems with data exported in user friendly formats.

For full CFR Chapter 21 Part 11 data integrity compliance, set-up data is stored in a secure database, with full data security and user action logging.

Full containment

Transfer method options include: continuous liners, cannisters and ventilated transfer boxes, or a combination of systems. Choice will depend on existing lab practices and required performance. When equipped with optional glove ports and containment, the HB100 can be used for tablet development using high potency pharmaceutical ingredients (HPAPIs/HAPIs) that demand containment to Occupational Exposure Band (OEB) 4 or 5.

In the high containment version, the HB100 offers equivalent functionality and advanced features within a fully isolated format, allowing glove port operation for working with high potency substances. The unique hybrid high air flow ventilation system also allows the system to be used without gloves for compounds up to OEB3.

It incorporates a separate control system for control, monitoring and test of the containment, along with a solvent level alarm for cleaning safety, and glove integrity test and leak protection systems.

For maximum user friendliness, the machine uses a convenient “push-push” mechanism for quick and safe containment filter changes.

Regulatory compliance

HB100 design and engineering meets all required European and North American safety and build standards while its control and instrumentation includes comprehensive data analysis software, that complies with 21CFR part 11 and GAMP5 guidelines, with outputs presented in encrypted and Excel readable TSV formats.

The high containment HB100 is factory tested to ensure its meets Class 3 requirements for isolator to ISO 14644-7 and ISO 10648-2 for isolation performance.

HB 100 powder compaction presses are CE certified and comply with UL requirements. They are manufactured under assured quality with Huxley Bertram Engineering processes and premises certificated gold standard ISO 9001:2015 requirements for design, manufacture, commissioning of its special purpose machines and automation equipment.

Huxley Bertram ensures all machine building and testing functions are performed in-house.

HB100 Performance Data

Resources

Click on Compaction Simulation for information on Huxley Bertram compaction simulators.
Click on Powder Compaction for further information on Huxley Bertram Powder Compaction Research machines.