Toll manufacturer 7 days a week 24 hours a day
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Services
Full service focused, we are able to support all stages of your project leading it to its successful implementation.
From technical support and file development to the complete release of the finished product into its final packaging. Our production is operating 7 days a week, 24 hours a day.
- Purchasing and control of the raw materials
- Compounding and Formulation in tanks and reactors
- Sterilization processes
- Industrial development
- Development, release and control of the packaging components
- Stability study according to ICH standards
- Development, validation and /or analytical methods transfer
- Manufacturing
- Storage
- Physical and chemical controls
- Microbiological controls
- Regulatory affairs
Purchase and control of the raw materials
- Limited access storage area.
- 150 raw materials in stock.
- Controls according to monographies.
- Weighing in class C environment.
Formulation in tanks and reactors
- Performed in class C.
- According to GMP’s.
- Batches from 50 to 2.500 liters.
Sterilization processes
- Bulk sterilization and aseptic filling .
- Sterilizing filtration and aseptic filling.
- Final post sterilization by autoclave.
Industrial development
- Formula development
:
- Participation in the development of new products.
- Reformulation of existing products.
- Pilot batches :
- Manufacturing process development.
- Stability studies.
- Process validation
:
- Pilot batches.
- Industrial batches.
Development, validation and /or analytical methods transfer
- More than 5000 references
- Raw materials sourcing
- Development
- Purchasing
- Control on receipt
Stability study according to ICH standards
- Definition of requirements and procedures for storage conditions
- Temperature and hydrometry monitoring : 5, 25, 30, 40°
- Analysis
- Report
Development, validation and /or analytical methods transfer
- Protocol development
- Feasibility study
- Trials
- Validation
- Reporting
Manufacturing
- 7000m² with 1200 in sterile area.
- 1200 references.
- 9 aseptic filling lines.
- 3 packaging lines.
- 2 aluminium blister lines.
Storage
- 8000 m² of storage in warehouses ( pallets ).
- 250 pallets located in cold room at 4°C.
Physical and chemical controls
Raw materials :
- Impurities assay .
- Finished products :
- Stability study.
- Impurities searching :
- 7 HPLC, 1 CPG, 2 spectrophotometer UV, COT meter, rheometer …
Microbiological controls
- Raw materials
- Bioburden, endotoxin.
- Finished product
- Antibiotic, sterility test into half-suit isolator.
- Environmental monitoring
Regulatory Affairs
- Technical support and file development
- Marketing Authorization file
- Medical device dossier (CE mark)