Preservative-free multidose

To meet the demands of our customers and the preservative-free multidose market, we have equipped ourselves with a multi-dose aseptic filling capacity. Unither can therefore offer the development services and subcontracting of ophthalmic formulas for PFMD technologies.

With more than 1.2 billion sterile doses manufactured each year, Laboratoire Unither Coutances is an Ophthalmological expert.
We are acting worldwide with products delivered in more than 100 countries.

Specifities

  • Filling: 5 mL, 10ml, 11ml, 15ml
  • Cases 1, 2 or 3 bottles
  • Aptar’s OSD® and Nemera’s standard Novelia® OSD® droppers
  • Other droppers under development

Advantages

  • no preservatives
  • Better product tolerance
  • prevention of microbial contamination throughout the treatment period
  • complement to the BFS ophthalmological range
  • bottle is easier to carry than several single unit dose vials wich generate no product waste making the form more environment-friendly

Manufacturing
process:

As with the BFS technology, the process design strongly limits the risk of environmental contamination as the machine is:

  • cleanable in-situ,
  • sterilizable in-situ,
  • integrated in a continuously monitored isolator
  • supplied with sterile vials and droppers, contained in specific bags allowing aseptic connection of the double door sealed transfer type (DPTE/RTP)

Authorizations

The site is regularly inspected by various authorities including: EU GMP, FDA, Brazil, MFDS (Korea), Russia, Belarus, and other health authorities around the world.

Manufacturing plants and capacities

Total capacity : > 100 million bottles/year

Coutances, France

Butantã, Brazil

Blow-fill-seal

Liquid Stick-Packs

Bottles