Sterile eye/nasal drops
PRODUCTION PROCESS
Manufacturing Capabilities
- Plastic dropper bottle for multi-dose use
- Filling and capping in monoblock under RABS - new line, started in 2014
- Sterile filtration in one or more steps
- OEE software tracking of process performance and efficiency
- Mixing volume: 50 - 3,000 l
- Commercial batch size: 10,000 – 300,000 pcs
Packaging Presentations and Formats
- Filling volume: 1.5 - 10 ml
- Secondary packaging; min (20x15x65 mm) - max (100x100x230 mm)
- Custom packaging through adding various elements (e.g. vignettes), labels for cold chain, multi-packs
- Printed data inspected by an in-line camera (100%)
- Possibility of pouch wrapping and sleeve wrapping
Production Environment
- Bulk preparation in Class C, sterile filtration and filling in EU GMP Class A
- Total area 360 m2; Class A/B 51 m2 (completely reconstructed in 2014)
- On-line monitoring in Class A: air flow velocity, pressure difference, particles counter, humidity, temperature. All data are can be read and archived in the BMS system.
Equipment Capabilities
- Mixing tanks 20-3,000 l, tanks for sterile solutions in Class A 8-200 l. Integrated weighing syst
- Teflon-coated equipment for specific products.
- Moist heat sterilizators (autoclaves) - chamber size 300 and 1,300 l
- RABS bottle filling line capacity 15,000 units/hour
Capacity
Spare capacity
COMPETITIVENESS
- Sterile processing steps – operate under assurance level 10-6
- New RABS filling line started in 2014 within reconstructed A/B Class ensures highly controlled and safe environment for sterile production
- Speed size changeover
- High level of automatization from bulk preparation and sterile filtration to aseptic filling and packaging
- Variety in bulk processing (size, special coated equipment, multi-step preparation), separate or in-line sterile filtration with the filling process.