Blow-fill-seal (BFS): Overview
Unither is the unrivaled worldwide leader in sterile unit-dose production using Blow-Fill-Seal (BFS) technology, with products currently selling in over 85 countries.
- Throughout our sites in North America, Europe and South America we can manage the development of a drug product or a medical device from concept to marketing, providing the benefit of Unither's development expertise.
- Innovative, simple and easy solutions to improve customers’ products as well as extend existing product lines.
Advantages of BFS technology
Blow-fill-seal technology enables the manufacture of preservative-free single-unit doses. Preservatives are recognized as potentially harmful to the sensitive mucosae of the eyes, nose, and lungs, so this is an enormous benefit to sensitive patients.
Another advantage of unit-doses is that they ensure that the patient takes the correct amount of product, especially when dealing with highly potent compounds, i.e. those therapeutically active at a low concentration.
Sterile unit-doses are portable and easy to use individually, excellent properties for today’s active lifestyles. Blow-fill-seal (BFS) single doses are an ideal solution for use in ophthalmology, respiratory diseases, rhinology, antisepsis and wound care.
Experienced blow-fill-seal manufacturers
We have BFS production lines currently running cGMP batches at two sites in France, and lines are running in the US since Q1, 2017. All sites are inspected by European Authorities to provide the products to the European markets. One European site and the US site are FDA inspected to supply the American market. These sites are also inspected by ANVISA (Brazilian Authorities), Korean FDA and other Health Authorities worldwide.
With ongoing and committed investment in new high-speed BFS lines, our immense capacity allows us to welcome new projects of any size.
Unither’s BFS teams perform tech-transfer of products developed by their customers or third parties. They also perform the full development of drug products or medical devices on a custom basis. Thanks to its highly trained on-site dedicated R&D teams with dedicated pilot plants, Unither has the know-how, equipment and expertise to manage product development from the earliest stages.
High-speed blow-fill-seal lines
Delivering 1 billion unit-doses per year
Unit-dose contents from 0.25 mL to 5 mL
Rochester, NY USA
Blow-fill-seal technology - Key figures
- An installed capacity of over 2.5 billion unit doses per year
- Unit-dose contents from 0.25 mL to 20 mL
- 24 Rotative Bottle-pack lines
- 4 Alternative Bottle-pack lines
- Compounding and filling of solutions, suspensions, emulsions and gels
- Autoclaving, sterilization by filtration
- Specific know-how in the process development and manufacturing of:
- Oxygen-sensitive products (N2 compounding, filling and pouching)
- Heat-sensitive products
- Light-sensitive products
- Highly-potent drug products
- Several solutions for individual identification of the doses: ink jet printing, labels, embossing
- Pilot equipment for small batches (tech-transfer and clinical batches)
- Analytical R&D and QC laboratories for method development and validation, ICH stability studies, quality control and release