Multidose

Preservative-free Multidose (PFMD) & Multidose with Preservative (MDWP)

To meet the demands of our customers and the market, we have equipped ourselves with a multi-dose aseptic filling capacity. Unither offers development services and subcontracting of ophthalmic formulas for both PFMD and MDWP technologies.

One of our key facilities is Unither Laboratoire in Coutances, France, focusing on preservative-free multidose. Another major site is Unither's Butantã facility in São Paulo, Brazil, specializing in multidoses with preservative. Both locations specialize in ophthalmology. Continuous investments allow the company to manufacture ophthalmic health products across four continents: Europe, Asia, North America, and South America.

Specifities

 

PFMD:

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

MDWP:

  • Filling: 1.5 to 15mL
  • 2 sizes of folding box

Both PFMD and MDWP fit different statuses: drugs, medical devices, OTC, cosmetics, etc., and formulation types: ophthalmic solutions and suspensions, and otology products.

Advantages

  • 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, generating no product waste, making the form more environment-friendly
  • Calibrated drops
  • User-friendly
  • Adapted to chronic diseases
  • Adapted to different therapeutic areas: allergic, anti-infective, anti-inflammatory, glaucoma, DES (Dry Eye Syndrome), ocular hygiene solutions, New Chemical Entities (NCE), etc.

Zoom on PFMD 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 sites are regularly inspected by various authorities including: EMA (Europe), FDA (USA), ANVISA (Brazil), MHRA, KFDA, Russian MOH, Turkish MOH, Mexico, and other health authorities around the world.

Manufacturing plants and capacities

Total capacity:

More than 100 million bottles/year


Coutances, France

São Paulo, Brazil

 

Blow-fill-seal

Liquid Stick-Packs

Bottles