The centre of excellence for pharma spray drying for GEA Pharma Systems
Located at Niro A/S in Copenhagen, Denmark, this is the World’s
largest test centre of its type for process equipment.
The 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.
ORDER YOUR FREE TEST STATION INFORMATION PACKAGE TODAY
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 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.
Because 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 Niro Pharma Test Station is an addition to the well-established
non-GMP 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 PSD-1 spray dryer - lab size unit
The Pharma Test Station includes
two qualified GMP spray drying units:
- PSD-1 with a drying gas rat 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 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 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).
Read more about the Pharmaceutical
Spray Dryer - PHARMASD™ (PSD) here.