Preservative-free multidose

To meet the demands of its customers and the preservative-free ophthalmology market, Unither has equipped itself with a multi-dose aseptic filling capacity.

Unither can therefore offer the development services and subcontracting of ophthalmic formulas for both BFS and PFMD technologies.

Specifities

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

Advantages

  • No preservatives
  • Prevention of microbial contamination throughout the treatment period
  • Complement to the BFS ophthalmological range

Manufacturing
process:

The aseptic dispensing technology has been developed to achieve a very high level of sterility assurance.

As with the BFS technology, the process design strongly limits the risk of environmental contamination because 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 capacity

Coutances, France
> 25 million bottles/year


 

Blow-fill-seal

Liquid Stick-Packs

Bottles