Production and development of multi-doses, with or without preservatives

To meet our clients’ needs and market demands, we offer a range of aseptic multi-dose filling solutions. Unither offers development and manufacturing services for technologies for preservative-free multi-doses (PFMD) and multi-doses with preservatives.

Stérile
Sterile Single-Dose Units, Preservative-Free
Volume_Filling (1)
Filling Volume: Multidose with Preservatives: 1.5 to 15 ml / MDSC: 5 to 15 ml
Volume_Filling (2)
Classic and flexible vials, several presentations possible
Multidoses
personnalisation
Aptar OSD® and Nemera Novelia® Technologies
solutions supensions
Formulation Types: ophthalmic solutions and suspensions, otology products
statut
Statuses: pharmaceuticals, medical devices, OTC, cosmetics ...

Benefits of multi-doses

Choosing BFS means choosing simplicity, safety, and performance

  • Improved product tolerance
  • Prevention of microbial contamination for the entire treatment period
  • Complement to the BFS ophthalmic range
  • The vial is easier to transport than multiple single-dose vials and generates no product waste, making the format more environmentally friendly.
  • Calibrated drops
  • Easy to use
  • Suitable for chronic diseases
  • Suitable for a range of therapeutic areas: allergic, anti-infective, anti-inflammatory, glaucoma, dry eye syndrome (DES), ocular hygiene solutions, new chemical entities (NCE), etc.

Manufacturing sites and capacity

The Unither Laboratory in Coutances, France, is equipped for the production of preservative-free multi-doses, while our Butantã site in São Paulo, Brazil, specializes in multi-doses with preservatives. Both sites have expertise in ophthalmology and allow us to produce ophthalmic health solutions on four continents: Europe, Asia, North America, and South America, thanks to continuous investments.

The sites are regularly inspected by different authorities including the EMA (Europe), FDA (USA), ANVISA (Brazil), MHRA, KFDA, Russian MOH, Turkish MOH, Mexico, and other health authorities worldwide.

Out-licensing - our turnkey documentation and products in Blow-Fill-Seal (BFS) packaging

 Table: Out-licensing - our turnkey documentation and products in Blow-Fill-Seal (BFS) packaging
Multi-dose Volume Category Status Dossier Country
Sodium Carmellose (CMC) 0.5% and 1% 10.15 ml Ophthalmic MD CE Marking Brazil, US
Sodium Hyaluronate 0.15% 10 ml Ophthalmic MD CE Marking Brazil, US
Sodium Carmellose (CMC) 0.5% + Sodium Hyaluronate 0.10% + Glycerol 0.9% 10 ml Ophthalmic MD CE Marking Brazil, US
Hyaluronic Acid 0.15% 10 ml Ophthalmic MD CE Marking Contact us
Carragelose eye drops 3.2 mg/ml 10 ml Ophthalmic MD (IIa) CE Marking Contact us

End-to-end support from the initial phases: from concept to product

Manufacturing

From technology transfer to industrial manufacturing, from small clinical batches to commercial volumes.

Development

Formulation and analytical development, manufacture of clinical batches, stability studies, and expertise in ophthalmic development.

Out-licensing

Access medicines and medical devices that are ready to be registered and marketed.

Do you have any questions? - Consult our FAQ

Yes. Blow-Fill-Seal (BFS) technology offers great flexibility in terms of container design, whether for volume, shape, or tip. Tailored solutions are available for a range of applications, including pediatric tips for physiological saline solutions, ergonomic tips for ophthalmology, or Luer Lock necks for injectable products like Euroject®. The ability to customize your product in this way helps optimize administrative procedures based on the delivery route and patient profiles, while retaining the benefits of sterile single doses.

Yes. The polymer used in the Blow-Fill-Seal process (LDPE) consists of 100% recyclable mono-materials. This homogeneity simplifies waste management and promotes the circular economy. For example, at its Gannat site, Unither recycles LDPE scraps as reusable granules in a closed loop. This approach reduces the carbon footprint, improves waste management, and aligns BFS production with sustainability goals. Thus, BFS combines technological innovation with environmental responsibility.

Blow-Fill-Seal (BFS) is a fully automated pharmaceutical process that allows the production of sterile single doses with no direct human intervention. The container is first blown from plastic granules, then filled and sealed aseptically within seconds, in a closed and controlled environment.
This unbroken production method drastically reduces the risk of contamination and guarantees a high level of sterility, making it a reliable alternative to glass packaging for many drugs, medical devices, and vaccines.

Unither Pharmaceuticals is currently the world leader in BFS thanks to:

  • Over 30 years of continuous investment in this technology,

  • An industrial capacity exceeding 5 billion units per year,

  • Production sites on three continents, enabling us to support clients all over the world.

This unique expertise combines pharmaceutical quality, patient safety, industrial robustness, and flexibility for projects ranging from development to commercialization.

Yes. Despite the use of heat during plastic molding, the Blow-Fill-Seal (BFS) process is very fast, which limits exposure and preserves the integrity of heat-sensitive formulations. Clinical studies have shown that BFS-packaged vaccines, such as flu vaccines or GSK’s Rotarix®, maintain their efficacy and stability, equivalent to those obtained in glass vials. BFS is therefore a safe and innovative option for injectable or oral vaccines and biological products. The very rapid cycle of BFS limits thermal exposure (<40°C over the majority of the volume) and preserves the integrity of biological products, including recombinant protein vaccines. This has been demonstrated by several studies (GSK, MedImmune, Unither).

Our patented Sol-Gel™ technology allows the formulation of liquid ophthalmic hydrogels for production, which gel upon contact with tear fluid thanks to gellan gum. This property increases patient comfort, prolongs drug release time, and offers high bioavailability. Sol-Gel™ requires less active ingredient than traditional eye drops, which limits adverse effects. The first application, Solmyd™, offers effective mydriasis in a single instillation, instead of several successive drops.

Blow-Fill-Seal can be used in several therapeutic areas:

  • Ophthalmology: eye drops for glaucoma, dry eye, infections, or post-surgery treatments.

 

  • ENT: physiological saline solutions for nasal and pediatric hygiene.

 

  • Respiratory care: nebulization solutions for asthma, COPD, or cystic fibrosis.

 

  • Injectables

BFS allows the production of sterile preservative-free single doses, thus improving safety during delivery and facilitating compliance among patients suffering from these conditions.