MEDELPHARM STYL’One Evo DryCon® execution passes FAT and SMEPAC tests

Beynost, France: – Research-based manufacturer and powder compaction specialists MEDELPHARM has successfully completed factory acceptance and particle containment testing for a high containment version of its industry-leading STYL’One Evo compaction simulator.

The MEDELPHARM Technical Team recently successfully completed the Factory Acceptance Tests and for two STYL’One Evo DryCon® compaction simulators, also ensuring they met the ISPE standards for Standardized Measurement of Equipment Particulate Airborne Concentration (SMEPAC) standards to align with revised Second Edition Guideline.

STYL’One DryCon®

The STYL’One Evo DryCon® compaction simulator features an ergonomic design with high containment enclosure and glovebox operation, permitting product development with highly potent APIs (HPAPIs) with maximum safety and efficiency.

The instrument can be operated without the requirement for personal protective equipment (PPE).

The DryCon® version builds on the industry-leading STYL’One Evo platform, as a highly versatile single-punch tableting press for R&D, scale-up and production support uses. This all-purpose tableting instrument enables fast API characterization and single layer to multi-layer formulation development using minimal quantities of powder!

Versatility

The fully instrumented STYL’One Evo ’tableting robot’ can explore the QbD design space in analyzing formulations, including target thickness to mimic rotary tablet presses, multi-layer tablet and tab-in-tab simulation, with roll compaction mimicking for ultimate material economy.

The high containment additions include full OEB5 containment solution with isolator, combined with negative pressure control and monitoring, air filtration, and safe cleaning to reduce operator exposure risks.

The tablet press can safely run while the operator performs other tasks inside the contained chamber like weighing, hardness measurements or cleaning. The STYL’One Evo Contained can also be safely operated with the isolator open when manipulating non-hazardous material.

MEDELPHARM recently joined the KORSCH family, and the new platform will be distributed via KORSCH and MEDELPHARM outlets in Europe, North America and South Asia alongside other versions of the STYL’One Nano and STYL’One Evo compaction simulators.

About MEDELPHARM

Headquartered near Lyon, MEDELPHARM is a high-precision engineering company manufacturing R&D tablet presses and providing innovative solutions for powder analysis and formulation.

Since 1985, MEDELPHARM have been specialists in ‘Made by people for people’ tableting instruments that work with high-speed and precision but at the same time are very easy-to-use.

Since the end of 2022, it has been a member of the international KORSCH Group, enhancing its worldwide reach.

With its historical background in actual production, MEDELPHARM has a deep understanding of the R&D requirements that apply to tableting processes.

For formulation and pilot plant scientists around the world looking for assistance in powder characterization, solid dosage formulation or production trouble shooting, MEDELPHARM can offer a comprehensive portfolio of versatile R&D presses and high-speed compaction simulators supported by a team of dedicated Scientists.

For more information, visit: www.medelpharm.com

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