Spray Drying for Pharma Applications GEA Farmasötik GMP Sprey Kurutma Tesisi

The GEA pharmaceutical GMP spray drying facility - one of the world’s most advanced centers of excellence - is available for the production of samples for process development, stability/toxicology studies and clinical trials material and, when required, spray drying intermediates for human medical products for commercial use.

Spray drying is a fast and gentle way to produce free-flowing powders and a process that allows very precise particle form control. The technique can be used in pharmaceutical production to obtain several benefits, including increased bioavailability, controlled release or taste masking. It can also be used to produce fine powders for inhalation or other applications.

Pharmaceutical Spray Drying

The GEA pharmaceutical spray drying facility is fully equipped and cGMP-compliant. We offer spray drying process development as well as the contract manufacturing of spray dried intermediate drug products. The facility includes two GEA PharmaSD™ spray dryers: a PSD-1 spray dryer with a feed rate of up to 10 kg/h for initial cGMP testing and small-scale production; and a full-scale PSD-4 unit.

This means that 1:1 trials can be performed — enabling direct technology transfer from testing to commercial production. Initial tests can be done under flexible conditions at our non-GMP test center prior to cGMP-condition testing. 

In early dosage form development, when only very small amounts of API are available, GEA DRYNETICS™ enables formulation developers to screen for the effects of various solvents (humidity and drying temperature) and excipients.

Spray Drying Expertise

A dedicated team is available to help you. Our expertise includes processing APIs and excipients using spray drying, encapsulation and spray congealing, as well as spray drying of final drug formulations.

Working with GEA at the test center enables you to experiment with spray drying, conduct tests and develop your product — before making any major capital investment — to quickly and effectively achieve proof of concept. Efficient technology transfer and key personnel training also enables you to compress the time needed to switch to commercial production. 

In 2004, GEA inaugurated its own pharmaceutical GMP spray drying facility authorized by the Danish Medicines Agency for the production of non-sterile intermediates for clinical trials (in humans). In 2014, the authorization was extended to cover the spray drying of non-sterile intermediate medicinal products for commercial use.

Spray drying is an excellent tool for particle engineering

  • to produce powders with very specific properties
  • to increase the bioavailability of an API
  • for taste-masking or controlled release

Spray drying can be applied for

  • temperature sensitive products
  • and to make direct compressible powders
 

cGMP Contract spray drying of pharmaceuticals

The GEA pharmaceutical spray drying facility includes two fully equipped GEA-PSD-1-CC and PSD-4-CC PharmaSD™ spray dryers for cGMP spray drying applications. The facility is available for process development and manufacturing.

Plant configuration

  • Main components: chamber, cyclone, bag filter, hepa filters, condenser, electrical heaters
  • Nitrogen as drying gas
  • Closed-cycle loop
  • Powder collection under cyclone, fines collected by bag filter, for PSD-1-CC all powder can be collected by bag filter
  • Atomization methods: pressure nozzle, co-current (PSD-4-CC); two-fluid nozzle, co-current (PSD-1-CC and PSD-4-CC).

Feed options

  • Mixing of various solventsS 
  • Dosing and mixing of various raw materials 
  • Filtration of feed.

Solvents

  • Water
  • Ethanol
  • Methanol
  • Isopropyl alcohol
  • Acetone
  • Methylene chloride
  • Ethyl acetate.

Operating parameters

Inlet temperature up to 180 °C
Outlet temperature  up to 150 °C
Condenser temperature down to -18 °C
Feed temperature 5 °C to 80 °C
Pressure nozzle, atomization pressure 10 bar to 100 bar
Two-fluid nozzle, gas pressure 0.5 bar to 14 bar
Two-fluid nozzle, atomization gas temperature 18 °C to 100 °C
CIP liquid temperature up to 80 °C
PSD-1-CC drying gas rate, nominal 80 kg/h
PSD-4-CC drying gas rate, nominal 1250 kg/h