By MEDELPHARM S.A.S
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Medelpharm Tableting Instruments: the new generation of compaction simulator
Medelpharm specializes in developing, engineering and manufacturing high precision R&D tablet compaction simulators that can be used to research and develop optimum production processes for compressing powders into various tablet forms.
The STYL’One range allows users to reduce the risk of scale-up issues by compressing the powder at production speeds using production press profiles to assess suitability of product with as little as 20g of development formulation.
These platforms provide intelligent tablet press technology and software development solutions for powder analysis and formulation as part of Medelpharm’s overall mission.
Medelpharm is continuously developing innovative research hardware and software to assist scale-up to industrial production presses, powder characterization, formulation and material sciences in the pharmaceutical, food, and cosmetics markets.
They can mimic a wide variety of production tablet press profiles as well as enabling alternative V-shaped profiles for material characterization testing. The accurate data gathered bring huge savings in both time and money during the scale up and production processes.
STYL’One tableting instruments
Evolving from the groundbreaking STYL’One Classic, there are now two machines in Medelpharm’s STYL’One range:
- STYL’One Compaction simulator: This tableting instrument is a high-speed, all-in-one multilayer tool designed for use in tablet development from early formulation to scale-up at production speed. The machine characterizes essential powder properties and active pharmaceutical ingredients (API). It tests their suitability by simulating industrial production cycles, typically up to 400,000 tab/hour (dwell time <2ms), with only a few grams of powder needed.
- STYL’One Nano benchtop R&D press for tablet development: A highly advanced benchtop tablet press combining compact form with extensive instrumentation and capabilities, including saw tooth, square, pre/main compression profiles, independent setting of force and position control, fill height and compression thickness, along with extended dwell times.
Both machines are entirely controlled by software and the touch screen Human Machine Interface (HMI) that allows each process parameter, such as filling height or compression thickness/force, to be precisely specified. They also comply with the recently introduced USP General Chapter <1062>on tablet characterization.
ANALIS tablet properties analysis software
STYL’One capabilities are extended by Medelpharm’s proprietary ANALIS software for streamlining tableting development and production processes. ANALIS is optimized for use on MEDELPHARM systems but can also be used with industry standard hardware.
ANALIS uses Heckel, force hardness and other standard reporting parameters to create detailed individual analyses, working with single data points during a compression cycle or exploiting average values during batch production.
The basic ANALIS package can be extended in two ways:
- ANALIS Multilayer: upgrading STYL’OneEvo into multilayer and tab-in-tab machines.
- ANALIS GMP Production: enhanced control over clinical batches in a GMP-compliant regime, equivalent to an automated regulatory inspector. Built on SQL database, this module rigorously controls and tracks production, making sure all parameter changes are recorded. Fully CFR Part 11 compliant, the module has been developed according to GAMP 5 guidelines.
Medelpharm is an international enterprise, located in Lyon, making available the most powerful, still easy-to-use R&D tableting presses like STYLCAM and STYL’One to every formulator and development scientist.
You are looking for assistance in API and excipient characterization, solid dosage formulation or production trouble shooting? Please come and visit our tablet science laboratory in Lyon.
Medelpharm offers a comprehensive portfolio of Mechanical Compaction simulators, Multifunction R&D Tablet Presses, and Process equipment and extensive Services in tableting, granulation and coating.