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    Expanding STYL’One tableting R&D capacities with MEDELPHARM accessories

    products-servicesMEDELPHARM S.A.S
    August 4th 2021

    MEDELPHARM offers a wide range of accessories and options that can significantly extend the already formidable capabilities of the STYL’One Evo and STYL’One Nano as tableting press platforms for  Research & Development, scale-up and production support.

    These add-ons variously provide data acquisition and analysis capabilities for advanced formulation,. more closely tailor these machines to specific R&D laboratory applications, expand their production capacities, and adapt them to high containment and  Enhanced Operator Safety (EOS) environments.

    STYL’One Evo standard features

    The STYL’One Evo is the most versatile single-punch tableting press for Research & Development, scale-up and production support. This all-purpose tableting instrument enables fast API characterization and single layer to multi-layer formulation development. Develop your formulation at full production speed with only a few grams of powder!

    Fully instrumented, the STYL’One Evo is a real “tableting robot” to explore the design space (QbD) and analyze formulations with utmost efficiency.

    Standard features include:

    • Force, displacement and radial measurements
    • Force mode for cost-saving on API characterization
    • Target thickness to mimic rotary tablet press
    • Manual, advanced gravity and force feeding options
    • Multi-layer up to five layers with three products
    • Automatic core feeding system for tab-in-tab
    • Replication of all types of rotary tablet presses
    • Roll compaction mimicking for ultimate material sparing
    • Base Analis software data acquisition and analysis package

    However, these are just the starting point. STYL’One Evo is a highly flexible and adaptable platform with many modules and accessories to fit specific needs. These include:

    • Upgradable to full cGMP production standards with external lubrication
    • Exchangeable hard chrome mirror finish die table for a cleaner finish
    • Additional Analis modules for advanced formulation needs.

    Analis Software functions

    The full Analis analytical package for fast formulation screening comes as standard with every STYL’One Evo.

    Analis provides advanced machine control functions, such as pre-defined compression profiles to mimic rotary production presses and for STYL’One Evo to be run in force or displacement mode for advanced R&D needs.

    The Analis suite of specialized software modules also provide:

    • Multi-layer and tab-in-tab
    • Roll compaction for dry granulation feasibility assessment
    • GMP compliance for clinical and commercial batch production
    • Automatic data transfer from tablet testers
    • Profil’One creation of tailor-made compression profiles

    The base Analis R&D module can also be installed on legacy single punch presses to share

    R&D accessories

    The STYL’One Evo benefits from a great number of options and accessories for use in specific R&D applications and environments. These include:

    • Innovative paddle force feeders
    • Instrumented die for radial pressure
    • Take-off force sensor
    • Dual scale sensors
    • Temperature controlled die
    • Linear ejection system
    • Good and bad tablet sorting chute
    • Multi-layer module
    • Tab-in-tab device
    • Roll compaction mimicking for ultimate material sparing

    GMP Production accessories

    The STYL’One Evo can be fitted with many accessories to adapt it to cGMP production needs, such as:

    • Dedicated GMP software module for CFR part 11 compliance with full production reports, user matrix and FDA audit trail
    • Automatic weight regulation monitoring for quality control in production with tablet reject
    • Good/bad tablet selection with de-duster integrated for batch production or weight regulation
    • Linear ejection system
    • Force feed shoe for multilayer tablets, controlled by software multilayer module or by manual feed
    • Selection of available force paddle feeders
    • Gravity feeder with choice of funnels
    • FAT/SAT and IQ/OQ validation.

    MEDELPHARM Distribution also provides advanced operator training,

    STYL’One Nano

    The STYL’One Nano is MEDELPHARM’s revolutionary benchtop R&D tablet press for demanding formulation scientists optimised for price performance. The Nano allows research labs to characterize API and develop single layer formulations from just a few grams of powder.

    Standard features include:

    • Integrated Alix R&D software platform
    • Force, displacement and radial measurements
    • Bottom punch dynamics similar to the movements of a rotary press
    • Designed with USP <1062> in mind (square, V-shape, pre- and main compression)
    • Force mode for cost-saving on API characterization
    • Target thickness to mimic small turret rotary tablet press
    • Manual, advanced gravity and force feeding options
    • Supports standard multi-tip and shaped tooling for production presses
    • Easy clean in place (CIP)

    STYL’One Nano capabilities can be further expanded with additional Alix software modules, along with instrumented die or an external lubrication system.

    STYL’One external and Lubrication solutions

    For many years MEDELPHARM engineers have focused on resolving sticking issues and minimizing ejection forces. Their successful research led to different developments to offer external lubrication, spraying lubricant where it’s needed and reducing its amount inside the formulation.

    They have developed two innovative solutions for these issues:

    • STYL’One Mist: handy dosing spray, calibrated at 0,3 mg magnesium stearate/puff to be sprayed directly on the punch and die. It replaces comfortably the brush and vacuum procedure used in many labs. The Mist spray can be used on any single punch press!
    • MEDELPHARM lubrication pack: purpose-designed to deliver small quantities of lubricant required by single punch presses. It consists of a ‘puff box’ control system that dispenses a small dose of lubricant at given intervals on the punches and die, along with a compact and cost-effective micro-dispensing unit that delivers small metered doses of lubricant.

    Safety (EOS or high containment)

    The continuing trend towards use of ever-more potent powders has made higher level of protection essential to ensure operator safety.

    The STYL’One series provides three operator safety configurations that  differ in specifications, technology and budget.

    • Standard fit: All STYL’One instruments are easy to clean and produce tablets with minimal amount of active material in the compaction area. The standard vacuum system keeps the compaction area clean and under negative pressure, limiting the exposure for the operator. STYL’One Nano and STYL’One Evo can also be placed in down flow booths for user protection.
    • Enhanced operator safety (EOS): The EOS package has been designed to add an extra layer of safety by limiting operator exposure to airborne particles during operation. Vacuum and manual control of air flow ensure that the machine is permanently under negative pressure. The STYL’One Evo compaction area can also be flooded with Nitrogen allowing experiment with Oxygen-sensitive or explosive powder.
    • Full OEB 5 containment: When using HPAPIs, MEDELPHARM can supply a full OEB5 containment solution with isolator that can be deployed for both R&D and GMP applications. The negative pressure control and monitoring combined with air filtration and safe cleaning drastically reduce operator exposure. The tablet press can safely run while the operator perform other tasks inside the contained chamber.

    Resources

    Click on MEDELPHARM STYL’One Accessories for more information.

    Expanding STYL’One tableting R&D capacities with MEDELPHARM accessories

    STYL’One Evo: versatile single-punch tableting press for R&D, scale-up and production support.

    Expanding STYL’One tableting R&D capacities with MEDELPHARM accessories

    Flexible feeding systems: Tablet in tablet (pictured) or Multilayer force feed shoe for up to 5-layertablets.

    Expanding STYL’One tableting R&D capacities with MEDELPHARM accessories

    Alix control and formulation software platform provides access to all data anywhere.

    Expanding STYL’One tableting R&D capacities with MEDELPHARM accessories

    STYL’One Nano: Bundled with Alix to provide a highly advanced tableting research environment in ultra-compact form.

    Expanding STYL’One tableting R&D capacities with MEDELPHARM accessories

    OEB 5 solution (pictured here) offer the highest level of user protection while EOS solution (Enhanced Operator Safety)has been used in nitrogen flooding of compaction area in handling oxygen sensitive substances, for explosive substances or simple operator exposure control.

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