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.