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Formulation Services
Koura have launched a new formulation service designed to support early-stage development studies specialising in HFA152a with internal capability to formulate and test pMDI products at bench and pilot (5L) scale.
Contact us today to see how we can work together
Research and Development
- Analytical expertise in HPLC, HPLC-MS, GC, moisture
- MDI characterisation techniques
- Bench scale formulation optimisation
- Materials compatibility with propellant
- Leachable testing
- Stability testing
- Expertise in lab scale flammable gas handling
Pilot Scale Manufacturing
- pMDI manufacturing facilities in Zone D/ISO 8 capable cleanrooms designed around filling of flammable propellants
- Production capacity
- 200-2000 units per batch Single Stage or Dual Fill
- Facilities to sample/dispense APIs in low oxygen/humidity atmosphere
- Separate facilities for check weighing/stress testing/packing/storage
Quality Control Laboratories
Capability and instrumentation to support pMDI incoming inspection and finished product testing:
- HPLC
- GC
- FTIR
- Moisture
- Aerodynamic Particle Size (Cascade Impaction)
- Dose Uniformity
Quality Assurance Systems
Electronic GMP qualified systems implemented across business:
- Electronic Pharmaceutical Quality System (Documentation, CAPA, Deviation, Change Control)
- Openlab CDS
- LIMS
