September 2022 - Huxley Bertram

Huxley Bertram Commission Multiple Compaction Simulators In North America

Throughout 2020 and into 2022 Huxley Bertram has extended its penetration, with implementations of their compaction simulators under containment, installed into major pharmaceutical companies throughout North America. Huxley Bertram has completed Site Acceptance Testing of multiple highly sophisticated powder compaction simulators. Designed and manufactured at Huxley Bertram’s headquarters in Cambridge (United Kingdom).

The compaction simulators under containment have been commissioned and successfully tested at numerous locations throughout the USA. The majority are commissioned or are undergoing Safebridge-directed surrogate testing (Summer 2022)

The powder compaction simulators belong to Huxley Bertram’s 4G class of HB50 and HB100 Tablet Compaction range, which incorporate innovative advanced features and instrumentation, such as:

1000 mm/s punch velocity, enabling the true simulation of high-speed rotary presses

Deep containment with hybrid configurations

Assessment of tablet “true hardness” through on-axis indentation testing

Tablet Testing Module (TTM)

Hiestand functionally enabling the assessment of tableting indices

Enhanced usability and productivity:

Tablet output sorting via the smart sorting carousel
Automated, in-simulator measurement of tablet weight, diameter, and thickness
Automated in-simulator measurement of diametral tablet breaking force
Hybrid containment approach; OEB containment levels and usability provide safe occupational exposure to active pharmaceutical ingredients (API’s) and hazardous active pharmaceutical ingredients (HAPI’s)
Streamlined simulator control software, with containment features and enhanced post-processing
Next generation feeders

Huxley Bertram continues to focus on continual design enhancements with the development of its containment features, with the purpose of increasing the safety and usability of its contained offering; the Tablet Testing Module (TTM) is a further example, which allows the measurement of tablet weight, dimension, thickness, and breaking force, without transferring tablets out of the isolator and the attendant scientist intervention, which traditional manual processes require.

The majority of customers are specifying containment configurations with the Huxley Bertram Tablet Compaction Simulators.

CMAC Partners with Huxley Bertram to Provide Compaction Simulation Research and Services

Founded in December 2020, CMAC and Huxley Bertram established the Compaction Simulations Pilot Test Facility providing Compaction Simulation Research Services through CMAC’s National Facility team. The Compaction Simulation Test Facility and services have proved to have been very successful throughout 2021 and 2022. The offering is unique with the support of analytical services, available to the CMAC team.

The initiative is supported by the partnership between HuxleyBertram and the CMAC Future Manufacturing Research Hub, based at the University of Stratchclyde (Glasgow, UK). An HB50 Huxley Bertram Tablet Compaction Simulator specified with instrumented dies and innovative process analytics for in-situ measurements using terahertz spectroscopy has been installed at CMAC’s facilities. Compaction simulation research is being led by academics and scientists at CMAC, with expertise in compaction simulation. With cutting-edge application and engineering support provided by Huxley Bertram’s Cambridge-based staff.

Compaction Simulation Services

Varying levels of Compaction Simulation services and development are available on a contract basis:

Material characterisation and advanced compaction studies of active pharmaceutical ingredients (API’s), excipients, and blends
Routine powder characterisation, constitutive analysis (axial stress/strain
Compatibility, compressibility, and tabletability studies
Radial analysis (Instrumented Dies)
Advanced compaction studies: radial analysis, frictionless ejection
Die compaction (rotary press) roll compaction and capsule tamping
High-fidelity rotary presses simulation, including hybrid MODUL simulations
Material-sparing replication of direct compression and dry granulation processes (DC/DG)
Formulation assistance and optimisation including lubrication studies
Formulation design, development, and scale-up

Process Understanding Development

Compaction and materials science understanding by pairing compaction simulation with advised characterisation techniques: X-ray computed nanotomography, time-of-flight secondary ion mass spectrometry
Compaction thermodynamics, in-die temperature evolution
Microstructure analysis using terahertz spectroscopy and x-ray computer nanotomography
Troubleshooting of clinical and commercial die compaction processes