Blow-Fill-Seal production

Medical device — saline solution for inhalation Licensing-out: sterile single-dose Blow-Fill-Seal

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Support for pulmonary administration by nebulization

Inhalation therapies require solutions compatible with nebulization, sterile and preservative-free, in order to avoid respiratory irritation and microbiological contamination.

Multi-dose formulations may present hygiene constraints and compatibility limitations with certain active substances.

In this context, ready-to-use single-dose formats are preferred to secure administration and simplify use both at home and in medical environments.

A supportive solution for inhalation therapies

An isotonic saline solution enables:

  • dilution or dissolution of inhaled medicinal products
  • homogeneous pulmonary administration
  • use across different patient populations
  • standardization of nebulization protocols
Blow-Fill-Seal unit doses

The solution developed by Unither

Unither offers a sterile, preservative-free 0.9% sodium chloride solution intended for inhalation therapy.

Objective: provide a nebulization-compatible support solution adapted to single-dose use

 

Key characteristics

  • Sterile preservative-free solution
  • Single-dose 2.5 mL and 5 mL
  • Packaged in pouch or box
  • 0.9% sodium chloride
  • Shelf life: 36 months ≤ 25°C

Key benefits of the 0.9% sodium chloride Blow-Fill-Seal solution

✓

Sterile

Single-dose packaging limiting contamination risks.

✓

Therapeutic compatibility

Can be used as a diluent for nebulized medicinal products, enabling aerosol generation for pulmonary delivery.

✓

Target population

Suitable for infants, children, and adults.

✓

Standardized use

Format adapted to hospital protocols and self-administration.

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
BFS (Blow-Fill-Seal) Volume Category Status Dossier Country
Carmellose sodique (CMC) 0,5% 0,4 mL Ocular OTC Monograph File available US
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