Sterile mechanical sprays

PRODUCTION PROCESS

Manufacturing Capabilities

  • Plastic or glass bottle with snap-on pump for multi-dose use in the form of a spray or drops, without preservatives.
  • Filling and closing (pump placing) in monoblock
  • Usage of pre-sterilized primary packaging material or sterilization on site (autoclaving glass bottle)
  • Mixing volume : 100 - 3,000 l
  • Commercial batch size: 20,000 – 100,000 pcs

Packaging Presentations and Formats

  • Filling volume: 2.5 - 30 ml
  • Secondary packaging; min (20x12x70 mm) - max (95x75x230 mm) 
  • Use of an aeroplane or reverse flap pack

Production Environment

  • Bulk preparation in Class C, sterile filtration and filling in EU GMP Class A
  • Total area 420 m2; Class A/B 45 m2
  • Latest phase of project; equipping two new sterile departments, doubling the capacities
  • On-line monitoring in Class A: air flow velocity, pressure difference, particles counter, humidity, temperature. All data cn be read and archived in the BMS system.

Equipment Capabilities

  • Mixing tanks 135-3,000 l, tanks for sterile solutions in Class A 50-200 l. Integrated weighing system. 


COMPETITIVENESS

  • Sterile processing steps – operate under assurance level 10-6
  • Preservative free multi-dose products mainly for nasal and ophthalmic use in a wide range of formulation and regulatory categories; from nasal salines and medical devices to drug products.
  • Extensive range of spray and drops pumps, with very accurate dose volumes, adding accessories to make use highly adaptable to customers
  • High level of automatization from bulk preparation and sterile filtration to aseptic filling and packaging
  • Variety in bulk processing (special equipment, multi-step preparation)