The GEA Niro Pharma Test Station is the world’s most advanced GMP test station for spray drying. It can be used to refine products and processes and to produce material for safety, stability and toxicology studies and clinical trials.
Spray drying offers a number of unique advantages for pharmaceutical companies:
• Increased bioavailability
• Controlled release or taste masking by encapsulation
• Aseptic production
• Production of fine powders for inhalation
The GEA Niro Pharma Test Station enables you to answer crucial questions about your product and processes and achieve proof of concept quickly and effectively – before you’ve made a significant investment in production facilities and in-house expertise. As full-scale tests can be performed, customer’s key personnel can be trained and processes can be qualified while establishing a commercial production unit. This substantially compresses the time needed to switch to commercial production.
The GEA Niro Pharma Test Station is an addition to the well-established non-GMP GEA Niro Test Center, which is the major competence centre for spray drying technology, where initial trials can be performed under flexible conditions before entering GMP conditions.
The Pharma Test Station includes two GEA Niro PHARMASD™ qualified GMP spray drying units:
• PSD-1 with a drying gas rate of 80 kg/hr.
• PSD-4 with a drying gas rate of 1250 kg/hr.
Both plants use nitrogen as the drying medium in a closed loop, which allows for drying of feed compounds containing organic solvents. While the powder is collected under the cyclone, a bag filter is used for collecting fines. Alternatively, all powder can be collected under the bag filter. There are two atomization methods: a pressure nozzle or a two-fluid nozzle, both operating in co-current mode.
|The PSD-1 spray dryer is a lab size unit with a feed rate of up to 10 kg/hr depending on solvent type.|
The size of the PSD-4 spray dryer matches the size of an actual production unit for many projects. This means that 1:1 trials can be performed, enabling direct technology transfer from testing to commercial production.
A productive and safe working environment
A dedicated building houses a complete support system to aid the processing of material for the two GMP spray dryers. The two dryers are, however, totally separated and have their separate HVAC system.
Every area of the GEA Niro Pharma Test Station – from the material reception area, feed preparation rooms and operation control rooms to the spray drying and powder collection systems – are designed to provide a productive and safe working environment for the testing and production of pharmaceutical material. 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).
GEA Niro Pharma Test Station - Spray drying