Product, environmental and occupational safety requirements are increasing for pharmaceutical producers because of new trends in active ingredients and regulatory changes. When it comes to tableting, dustproof production will become the minimum standard. That’s why in the future Fette Compacting will offer all new tablet presses with a containment option. The FE55 rotary press will be the first to do so at ACHEMA 2015.
Frankfurt a.M./Schwarzenbek, 15 June 2015 – Toxic, potent and mutagenic active ingredients are increasingly being used in the pharmaceutical industry. This trend is becoming particularly evident in the case of High Potency Active Pharmaceutical Ingredients (HPAPIs). Today, a quarter of all active ingredients under development are highly potent. Experts anticipate that the global market for high potency active ingredients will grow by more than 10% a year until 2018, while the pharmaceutical market as a whole is expected to grow by roughly 6% a year.
The increase in the use of potentially dangerous substances in pharmaceutical production is also changing the tableting process. Tablet presses have to compress powders and granules safely and efficiently. That applies equally to all substances in hazard categories OEB 3 (slightly toxic), OEB 4 (toxic) and OEB 5 (highly toxic). Pharmaceutical producers face the challenge of guaranteeing and continuously monitoring occupational safety in each category. The requirements of regulatory authorities have increased again here too. For example, protection against cross contamination has become an important subject as a result of the amendments to the EU GMP guidelines that came into force on 1 March 2015.
Fette Compacting makes dust-free tablet production standard
Under these circumstances, a dustproof machine can be expected to become the minimum standard for drug production in the future. In addition to special high containment solutions for HPAPIs, containment requirements will above all increase in the lower risk sector. Productivity as measured in costs by tablet will be a main driver when selecting the right machine, as efficiency is key to make modern medication affordable for as many people as possible. In order to guarantee manufacturers the optimum level of occupational safety and to ensure a high product quality, Fette Compacting is making efficient containment technology up to OEB Level 3 the new production standard. “We have found that the demand for appropriate containment solutions is rising among our customers worldwide,” explains Rainer Krugmann, Global Director Sales at Fette Compacting. “As a result, we have set ourselves the goal of offering all new tablet presses with an optional containment package that guarantees users dustproof production. With this enhancement we are the first manufacturer of tablet presses to offer the appropriate technologies for all containment requirements – from proven high containment machines to the new standard packages. We are making containment efficient.”
Premiere at ACHEMA: first containment option for FE55 rotary press
As a first step along this road, Fette Compacting is presenting the FE55 high-performance rotary press with a containment option at ACHEMA 2015. Users can already manufacture over 90% of all products with the FE55 as standard. From now on, this also applies to all toxic or potent active ingredients up to a dust exposure of 10 to 100 micrograms per cubic meter (μg/m³). For this purpose, Fette Compacting offers the FE55 with the option of containment components such as RTP access points and gloveports as well as simple parameter control via the machine terminal. This option will be available for all the models in the FE Series from the coming year.
The containment package for the FE55 / FE Series in detail:
- flap valve for safe product feed
- hermetically sealed and lockable window flaps
- RTP access points for the removal of components or tablet samples
- dustproof tablet discharge chute
- HEPA filter H13
- hand suction tube for precleaning
- interface for OEB3 deduster and IPC unit