- 5 million sales units / year
- Production in batch and/or campaign
- Maximum 2 shifts/day
- Aseptic automated filling line in Class A under isolator
- Final sterilization (autoclave) possible
- Mithra offers the latest generation, highly flexible, multiform sterile injectables manufacturing platform to its partners.
- Flexible aseptic manufacturing / filling and packaging process for nested technology : vials, ready-to-use cartridges, ready-to-use syringes.
- Adaptable to multiple pharmaceutical forms and APIs (hormones, non hormones)
- Diversity of products with high added value: aseptic filling line (200 pcs/min) combined with nested technology
- Small to medium batch sizes with optimized line clearances and set-uptime
- Cold chain products
- All in one filling line for a full range of formats (vial, cartridges and read-to-use syringes)
- Low and high viscous products can be processed (regular and vacuum technology)
- Flexibility: single process steps to full process according to customer requirements
- High security: grade A isolator technology for toxic configuration
- Reduced validation and qualification time: debagging with ‘no touch’ technology
- Reduced energy consumption by heat recuperation (HVAC)
- High environmental safety standards: cleaning- and steam-in-place stations (CIP/SIP)
- Capacity: 5 million sales units / year
- Production in batch and/or campaign, 2 shift regime
- Aseptic formulation
- Aseptic filling under grade A isolator
- In-line of final sterilization with steam/air autoclave
- New facility with state of the art equipment
- Process flexibility
- Nested technology: vials, ready-to-use cartridges, ready-to-use syringes
- Cold chain products
- Toxic products
- Central weighing with isolator and down flow booth
- Tank cleaning and sterilization in place with skid
- Closed compounding in 150 liter mobile vessel
- filling line (debagger, de-lidder/de-liner, flexible filler and capping machine) under isolator and Laminar Air Flow
- 2500 liter steam/air autoclave for final sterilization
- Manual Visual Inspection using standardized MVI benches
- plunger rod insertion and labelling machine
- Flexible secondary packaging line (blistering, cartooning, check weigher & tampon evident labelling, assembly, shipping table, serialization)
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