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Technologies & Innovations
Preservative-free multidose (PFMD)
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