Filter Dryer with Isolator for the Manufacturing and Handling of HAPIs
In the pharmaceutical industry the production of active pharmaceutical ingredients (API) is highly regulated because API are the active part of a drug and falls therefore under the food and drug administration responsibility. Clean and safe production of these ingredients, in a cost-effective way, is one of the most important targets for the production department of a pharmaceutical company.
Therefore, the equipment being involved in the production of APIs, and especially of high potency APIs (HAPIs), must combine, as much as possible, process steps in one device in order to decrease production cost and simplify cleaning of the apparatus. Also, reduction of dead spots to a minimum, or their stringent cleaning, are important factors to avoid cross contamination. For the safe handling of HAPIs, a glove box, sometimes also called an isolator, is a proven device to protect the operator and the environment from being harmed by the high potent ingredients. In some case the glove box protects also the product from contamination, if it has to be handled in an inert manner. Additionally, the glove box has to provide an ergonomic working interface between the operator and the product. The above mentioned points leads to a custom made apparatus with many special features.
A filter drier, being involved in the last production step of the HAPI before the galenics start, combines solid-liquid filtration, washing of the solid cake and its drying. The combination of these process steps in one device makes the filter dryer a welcome technology for HAPI production due to the above mentioned reasons.
MAVAG has an extensive experience in the area of mixing, filtration, drying and sterile processing technology and related equipment. We provide a sound basis for an innovative, economical approach to customer process and production needs.
A filter dryer in combination with a glove box adds also safe discharge, milling and packing of the high potent particles (HAPIs) to the above mentioned filter dryer process steps. In recent years MAVAG delivered an increasing number of filter driers in combination with isolators. The filter dryer in the pictures below, shows a technical solution where solid-liquid filtration, cake washing, cake drying, dry cake discharge, milling, packing and weighing of the HAPIs is done in one combined filter dryer – isolator device in a clean, safe, cost-effective and ergonomic way. Thanks to a unique filter bottom lowering procedure, the dead zone between filter plate O-ring and mating face of the vessel body flange can be fully cleaned. From an ergonomic point of view, a special door design provides a simple way to manually remove the product heel volume.
It is our aim to closely work with the customer and support them in selecting the proper components and systems that meet their specific requirements. MAVAG always welcome the challenge to develop solutions for your filtration and drying projects on pilot and production scale.
Contact Pfaudler today to learn more.