Bag on Valve

PRODUCTION PROCESS

Manufacturing Capabilities

  • Concept of continuous production in place
  • Completely automated and synchronized in-line process; from bulk production, sterile filtration, filling, capping and labelling to the final packaging
  • Commercial batch sizes; min. 10,000 pcs – max. five days continuous process
  • Possibility of "traditional" batch production, mix volume 1,000 l

Packaging Presentations and Formats

  • Filling volume: up to 300 ml
  • Can's diameter 35-66 mm, height 90-205 mm, tin plate BoVs with dip tube 90 - 205 mm
  • Secondary packaging; min (20x12x70 mm) - max (95x75x230 mm)
  • Use of aeroplane or reverse flap pack
  • Use of pre-printed can or label application (suitable for smaller quantities)
  • 2D code printing

Production Environment

  • Bulk preparation in Class C, filling line in separate area eq. to EU GMP Class B
  • Total area 280 m2; Class B/C 90 m2 
  • On-line monitoring of filling line area: particles counter, humidity, temperature, air flow velocity. All data can be read and archived in the BMS system.  

Equipment Capabilities

  • Pressurization, crimping and filling in monoblock capacity 60 units/min
  • Highly flexible, fully automated closing machine (for applicator and cap)
  • In-line mixing system equipped with 2 static mixers for liquids and API
  • Mixing tanks up to 1,000 l

Capacity

Spare capacity


COMPETITIVENESS

State-of-the-art technological platform, including production environment and practise, ensuring a high level of microbial reduction during processing without terminal sterilization. 

This results in:

  • Preservative-free multi-dose products, microbially stable up to 36 M of shelf life, even in case of products with a high risk of contamination."
  • Included possibility of producing sterile products by definition, terminal irradiation included
  • All benefits of continual production (higher efficiency, higher OEE, lower  COGS, parametric release)
  • Variety of BoVs, actuators and caps for solution in all categories generally recognized as suitable (saline/seawater sprays, wound cleansing/irrigation sprays, eyewash sprays, dermal drug delivery products, disinfectant sprays)
  • Speed size changeover, filling line can be easy upgraded to double capacity