Blow-Fill-Seal (BFS) is a continuous, automated process that requires no human intervention and guarantees a very high level of sterility.
Authorizations and approvals: FDA (Food and Drug Administration), NMPA (National Medical Products Administration), ANVISA (Brazilian health regulatory agency), SKFDA (South Korean FDA), EMA (Europe) and other health authorities worldwide.
Total capacity: 5 billion single doses/year (excluding China)
| BFS (Blow-Fill-Seal) | Volume | Category | Status | Dossier | Country |
|---|---|---|---|---|---|
| Hyaluronate 0.2% | 0.25mL | Ocular lubricant | Medical Device (ls) | CE Marking | Contact us |
| Hypertonic Saline Solution 3%, 6%, 7% | 4 mL | Inhalation | MD (IIa) | CE Marking | Contact us |
| Isotonic Saline Solution 0.9% | 5 mL | Rhinology, Ophthalmology | Medical Device (ls) | CE Marking | Contact us |
| Isotonic Saline Solution 0.9% | 2.5 mL, 5 mL | Inhalation | MD (IIb) | CE Marking | Contact us |
| Multi-purpose Isotonic 0.9% | 5 mL | Eyes, nose, ear, wound, inhalation | MD (IIa) | CE Marking | Contact us |
| Seawater | 5 mL | Rhinology | Medical Device (lls) | CE Marking | Contact us |
| Ofloxacin 1.5mg/0.5mL | 0.5 mL | Ear | Medicine | CE Marking | Contact us |
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).
Blow-Fill-Seal can be used in several therapeutic areas:
BFS allows the production of sterile preservative-free single doses, thus improving safety during delivery and facilitating compliance among patients suffering from these conditions.
