This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
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