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STYL’One Contained Tableting Development
MEDELPHARM’s series of STYL’One tableting instruments provides a range of solutions to industry needs for containment and isolation to provide regulatory compliant levels of operator protection when working with highly potent active pharmaceutical ingredients (HPAPIs).
The need for effective containment solutions has become ever more pressing as increasing focus on small and large molecule synthesis create new classes of high toxicity HPAPIs, with consequent shift in emphasis from protection of the molecule from cross contamination or deviation from process to prioritization of protection of the environment and workers from contamination by the molecule.
Three containment levels
The STYL’One series, comprising STYL’One Evo ‘tableting robot’ and the benchtop STYL’One Nano compact simulation tablet press, provides different levels of operator safety configurations which differ in specifications, technology and budget.
Level 1 – Standard: All STYL’One tablet presses are inherently easy to clean while generating minimal amounts of active material in the compaction area. The standard vacuum system keeps the compaction area clean and under negative pressure, limiting exposure for the operator. Both STYL’One Nano and STYL’One Evo can also be placed in a down flow booth for added user protection.
Level 2 – DryCon execution: STYL’One Evo DryCon has been designed to add an extra layer of safety by limiting operator exposure to airborne particles during operation. Negative pressure generation and monitoring, tighter seals, entry port, tablet recovery and alarm levels ensure that the machine is permanently under negative pressure. First cleaning with spray bottles can be executed to stick airborne particles to surfaces before opening the door.
Level 3 – WipCon® executions: A full wet containment solution with isolator that can be deployed for both R&D and GMP applications when using HPAPIs. The negative pressure control and monitoring combined with air filtration and safe cleaning reduce drastically the operator exposure. The tablet press can safely run while the operator performs other tasks inside the contained chamber, including weighing, hardness measurements or cleaning. The STYL’One Evo and STYL’One Nano WipCon® executions can also be safely operated with the isolator open when manipulating non-hazardous material.
STYL’One design and engineering
From the outset, the STYL’One Evo and Nano were designed as an easy-to-use and easy-to-clean R&D tablet presses with all parts easy to dismantle, cleanable in a dishwasher and with maintenance simplified to eliminate any pollution risks from hydraulic fluids.
Their clean form factors lower overall risk of exposure, as do technical designs that use only limited amounts of powder, with vacuum creating negative pressure in the compression zone.
For STYL’One Evo and STYL’One Nano, full containment can be extended to a glove station built around the tableting instrument. Tablets can be produced and checked before exiting isolator.
As a small-scale production presses, STYL’One instruments also meet FDA QA requirements for small production batches.