Delta Costruzioni Meccaniche S.r.l. and Food and Pharma Systems S.r.l. combined their expertise to develop a totally new approach for pilot-sized Nutsche filter dryer containment. Instead of installing a glove box at the discharge nozzle, the two technical teams designed and built a system where the machine body is totally included inside the isolator, allowing for complete Nutsche filter dryer management in contained conditions.
High-potency active pharmaceutical ingredients (HPAPIs) are a growing area within the pharmaceutical industry. According to the European Pharmaceutical Review, this segment represented 16.6 billion USD in the 2019 global market, and it is expected to grow at a rate of 8.7% from 2019 to 2027.
The ability to manage the production of these molecules is the result of the combination of the design of the plant and specific operating procedures.
Process machines face high-containment issues when dry product is outside the main chamber. This usually happens during:
The standard solution for HPAPI product sampling and discharging necessitates the installation of a glove box at the discharge nozzle on pilot-sized solid-liquid separation and vacuum drying machines, like the Nutsche filter dryer. Depending on the requested containment level, the isolator can have different features:
This offers multiple advantages like:
There are, however, some disadvantages:
Using a customer’s specific needs as a starting point, Delta Costruzioni Meccaniche and Food and Pharma Systems developed a totally different approach, which has addressed all of the aforementioned issues.
The glove box, which is normally externally connected to the Nutsche filter dryer, is totally incorporated into the lower part of the machine body.
This special design allows for the standard discharge procedure of a Nutsche filter dryer in a contained environment, but also allows for complete access to the internal parts of the machine. Since the lower part of the machine is in a contained environment, it is possible to lower the bottom and totally recover the product. Additionally, if a problem arises that requires machine repair, it is possible to do minor maintenance without cleaning and breaking the containment.
The core of the new technical solution is the custom flange located on the machine cylindrical body. This component has two tasks:
The design allows for a double barrier for each coupling. As such, failure is completely avoided:
The proposed design has a further advantage: since the hydraulic driving systems are totally outside the isolator, process contamination with oil is avoided.
Filter dryer main features: