24,000 Square Feet Dedicated to Contract cGMP Manufacturing of pMDIs, Nasal Sprays and DPIs
Exemplar merges product development activities with the ability to produce clinical and commercial products in a seamless, cost effective manner. Dedicated filling lines, equipment, space and staff are available and Exemplar will build to suit the client.
pMDIs
- Process development and validation
- Automated high speed filling lines
- Pressure filling (single stage and two stage)
- Canister purging
- Vacuum crimping
- 100% checkweighing
- 100% leak testing (non-water bath)
- 100% spray testing
- Unique equipment designed per client needs
- Individual filled canister labeling
- Variable batch scales, 4L to 1000L
- Secondary packaging
- Full release and stability testing
DPIs (developed in conjunction with known device companies)
- Formulation blending
- Packaging (cold formed blisters)
- Filling (capsules, blisters, diskettes)
- Blister sealing/cutting
- In process inspections (optical, analytical, seal integrity)
- Secondary packaging/pouching
- Full release and stability testing
Nasal Sprays
- Automated high speed filling line (single or multiple spray designs)
- Crimp on, snap on and screw on pump sealing
- 100% check weighing
- Individual in line filled bottle labeling
- In process inspections
- Secondary packaging
- Full release and stability testing