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.
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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
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
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 Assurance Systems
Electronic GMP qualified systems implemented across business:
- Electronic Pharmaceutical Quality System (Documentation, CAPA, Deviation, Change Control)
- Openlab CDS
- LIMS
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