Toll manufacturer 7 days a week 24 hours a day
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Manufacturing
Sterile liquids packaging operations in bottles and single dose units 7 days a week, 24 hours a day.
7000m² including a 1200m² clean area.
9 aseptic filling lines, 3 packing lines, 2 aluminium blister lines.
More than 1200 references
- Sterile water production
- Steam sterilization equipment
- Classified compounding areas
- Qualified personnel
- Control of raw materials
- Raw materials weighing
- Formulation and compounding in tanks and reactors
- Sterilization processes
- Filling
- Leak detection
- Labelling
- Laboratory controls
- Primary and secondary packaging components
- Storage
Sterilization
Water
- Purified water according to European Pharmacopoea 0009.
- Water for injection according to European Pharmacopoea 0169.
Water sterilization
PPI water storage 10 000 liters
Steam equipment for equipment sterilization
Steam equipment
Classified areas
Clean rooms A to D
Qualified personnel
- Continuous training.
- Trained, qualified, involved personnel.
- Supervision of pharmaceutical operations by Pharmacists 7 days a week, 24 hours a day..
Raw materials control
Methods according to monographies or internal procedures.
Weighing of the raw materials
Weighing in class C : Computer controlled system .
Formulation and compounding in tanks and reactors
Performed in class C according to GMP’s.
Batches from 50 to 2.500 liters.
Batches from 50 to 2.500 liters.
Sterilization processes
- Double skin reactor.
- Filtration at 0.22µm.
- Post sterilization in autoclave.
- Equipment by autoclave.
Filling
Leak detection
- B.F.S : 5,10,15 ml, 100% of the batch by vacuum.
- B.F.S : 0.4 à 0.6 ml 100% of the batch on-line.
Labelling
Laboratory controls
Physical and chemical testing
- Raw materials
- Impurities searching.
- 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 in half-suit isolator
- Environmental monitoring
Primary and secondary packaging components
Storage
Storage area
- 8000 m².
- Cold room.
