1 Development & Regulatory Affairs
- Dévelopment of pharmaceutical, veterinary (Part IIA to IIF), cosmetic and CE mark files under contract
- Manufacture of pilot and clinical batches
- Process development
- Mixers 15 kg, 50 kg (Broglie, Olsa)
- Weiss Ovens 25,30 et 40°C
- ICH norms
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2Purchasing and logistics
- Complete or partial components purchase for clients formulas
- Management of stocks, supply and logistic flows
- Automatised warehouse with 10 000 pallet places, 20 meters height
- Support by MRP
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MAR bottle filling machine |
Tube packaging workshop |
Planning |
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3Industrial Transposition
- Support for industrial transfer
- Analytical transfer
- Process validation
- Scale up
- Change control and variations management
- Maintenance of client pharmaceutical application file
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4Weighings and Manufacture
- Computerized weighinh unit, bar code secured flows
- Mixers from 300 à 10 000kg (Oscar Krieger, Moritz, Olsa)
- Vats from 500 à 10 000 l (Soneco, 3C, Guerin,..)
- Liquid phase grinders, air –removers and homogenisers
- Integrated processed (MES)
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| 5Conditioning
Filling under controlled atmosphere or laminar flow.
25 filling lines spread over 3 sectors :
- Tubes (aluminium, plastic or metalloplastique) : Kalix, IwKa
- Aerosols (nitrogen, CO2, butane-propane, compressed air, HFC 134a, pocket system) and pump sprays : Coster
- Liquids (glas, plastic bottles) : Mar, Kalish, Strunck et Kalix
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6Control & release
- Complete equipment up-to-date :
HPLC/ CPG / IR / UV
- Microbiological control
- Management by a LIMS
- Computer assisted release and computerised batch files
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