GEA Niro’s Pharma Test Station is one of the world’s most advanced cGMP spray drying facilities.
The facility is available for developing spray drying processes for pharmaceuticals and pharmaceutical grade products as well as for production of samples for safety, stability and toxicology studies and of Clinical Trials Materials.
Pharmaceutical Spray Drying
Spray drying is a fast and gentle way to produce free-flowing powders and a process that allows a very precise particle form control. Spray drying can be applied in pharmaceutical production to obtain several benefits, including increased bioavailability, controlled release or taste masking and aseptic production. It can also be applied to produce fine powders for inhalation or other applications.
GEA Niro Pharma Test Station
The GEA Niro Pharma Test Station is a fully equipped cGMP spray drying facility. We offer spray drying process development as well as contract manufacturing. Read the brochure on our Pharmaceutical Test Station and the brochure on pharmaceutical spray drying.
The Pharma Test Station includes two GEA Niro PHARMASD™ spray dryers. A PSD-1 spray dryer, which is a lab size unit with a feed rate of up to 10 kg/hr and suitable for initial test under cGMP conditions as well as small productions, and a PSD-4 spray dryer that is a production unit. This means that 1:1 trials can be performed ̶ enabling direct technology transfer from testing to commercial production. Initial tests can be performed under flexible conditions at our non-GMP Test Station before entering cGMP conditions.
In early dosage form development, where only very small amounts of products are available, GEA Niro’s DRYING KINETICS ANALYZER™ enables formulation developers to screen for the effects of various solvents ̶ their humidities and drying temperatures - and of various excipients.
Expertise in Spray Drying
A dedicated staff is available to help you. Our expertise includes processing of API and excipients using spray drying, agglomeration, encapsulation and spray congealing as well as drying of final drug formulations. We work with drug development projects for a multitude of companies and offer our assistance from initial drug delivery and formulation development to production of Clinical Trials Materials.
Working with GEA Niro enables you to work with spray drying, make tests and develop your product ̶ before making any major capital investments ̶ and to achieve proof of concept fast and effectively. And an efficient technology transfer and training of key personnel allows you to compress the time needed to switch to commercial production.
The GEA Niro Pharma Test Station holds a license granted by the Danish Medicines Agency for production of non-sterile intermediates for human medicine. It meets the EU’s requirements for the production of Investigational Medicinal Products (IMP).
Click on the menu on the left to learn more about the PHARMASD™ spray dryers at the Pharma Test Station and to see more of the facility!