High containment in tableting

High containment has become a global trend in pharmaceutical manufacturing due to several factors, primarily the increasing stringency of Labor Protection and Workplace Safety laws, advances in the field of environmental toxicology and most particularly the increasing sophistication of drugs with ever greater use of highly active materials.

This has caused some problems for tablet manufacturers, particularly at the laboratory development and piloting stages, where there is a need to work with many materials in short spaces of time. The main problem has been that high containment involves a trade off between safety and ergonomics, with cumbersome protection systems that slow down handling increasing the time needed to run multiple experiments on research tablet presses.

Handling HPAPIs

The need for effective containment solutions has become even more pressing, as the growing emphasis on both small and large molecules is creating new classes of high toxicity HPAPIs. This shift means we need to prioritize protecting the environment and workers from these harmful substances, rather than just focusing on preventing cross-contamination or process deviation.

MEDELPHARM’s series of STYL’One tableting instruments offers various solutions for the pharmaceutical industry’s requirements regarding containment and isolation. These instruments ensure that operators are protected in compliance with regulatory standards when handling potent drugs containing high potency active pharmaceutical ingredients (HPAPIs). This ‘menu’ approach provides laboratory managers with greater choice in matching the appropriate method level of operator protection with the materials being handled.

Protection  Range

The STYL’One series, comprising of STYL’One Evo compaction simulator and the benchtop STYL’One Nano compact R&D tablet press, provides three increasing levels of operator safety configurations that 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®:  For additional physical isolation, a press that uses small volumes of powders like the STYL’One can be fitted with a reinforced door sealing system, fitted with gloves that allow material manipulation while remaining protected, with the pressed tablets collected into sealed tablet sorters for subsequent measurements.

Negative pressure generation and monitoring ensure a controlled air flow and that the machine is permanently under negative pressure. The compaction area of the STYL’One Evo can also be flooded with Nitrogen allowing experiments with Oxygen-sensitive or explosive powder.

Level 3 – WipCon®: STYL’One Evo is also available in a full OEB5 compliant Contained Version. In this solution, the research press is fully running inside the isolation enclosure that forms a contained R&D space, operated through four pairs of glove ports at front and rear of the equipment, with manufactured tablets weighed and measured under full enclosure and data sent directly into the central database along with the data acquired during tableting.

Tools that have not been used or have been dismantled, can be cleaned inside the isolator thanks to a dedusting system and spray guns. At the end of the experiment, the whole workspace including the press and measuring equipment can be washed in place with spray guns and dried without breaking the containment.

All products and accessories can be moved through an RTP port to ensure constant safety.

The STYL’One research press full containment solution with isolator 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 STYL’One Evo WipCon® can also be safely operated with the isolator open when manipulating non-hazardous material.

STYL’One design and engineering

From the start, the STYL’One Evo and Nano were designed as 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 contained versions lower overall risk of exposure, as do their technical design that use only limited amounts of powder, with a vacuum creating negative pressure in the compression zone. These features allow the presses to meet Occupational Exposure Band OEB 1 and OEB 2 standards, where materials can have mild toxicity.

The additional DryCon® option allows the negative pressure to be controlled and monitored or for the equipment to be flooded with nitrogen.

Fitting glove ports to the front panel of the STYL’One Evo allows it to provide OEB 3 and OEB 4 protection levels for hazardous materials where a Restricted-Access Barrier System (RABS) solution is required to physically isolate the operator from substances being handled.

For STYL’One Evo, full containment can be extended to an eight-glove station as part of a dust tight enclosure surrounding built around the tableting instrument with additional features that ensure Occupational Exposure Limit (OEL) below 1 μg/m3 to meet OEB 5 protection standards. Tablets can be produced and checked before exiting the isolator.

This fully contained WipCon® STYL’One Evo press is also equipped with a water spray gun for Wash-in-Place (WIP) use, as well as a vacuum cleaner with internal connection for dust collection.

Each STYL’One Evo WipCon® and DryCon® execution is subjected to a certified third-party test conducted to International Society of Pharmaceutical Engineers (ISPE) Standardized Measurement of Equipment Particulate Airborne Concentration (SMEPAC) standards to validate the containment performance, with test reports included with the instrument documentation for regulatory validation.

Resources

Click on STYL’One Evo for more information.
Click on Containment is a growing demand in R&D tableting equipment for full briefing.