Blow-fill-seal (BFS): Overview
Unither is the unrivalled worldwide leader in sterile unit-dose production using blow-fill-seal (BFS) technology.
Through our sites in North America and Europe, we can manage the development of a BFS product from concept to marketing, providing the benefit of our development expertise. Every day, we provide innovative blow-fill-seal technology solutions to improve customers’ products and 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
Unither have been blow-fill-seal manufacturers since 1993, and currently runs CGMP batches on BFS production lines at two sites in France, with additional coming on-stream in the US in 2016. All sites are fully inspected and accredited by the relevant European Authorities, enabling the products to be sold on the European market. In addition, one European site and the US site are FDA inspected and accredited 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 as blow-fill-seal manufacturers allows us to welcome new projects of any size, at any time.
Unither’s blow-fill-seal (BFS) technology teams undertake tech-transfer of products developed by our customers or third parties. They also undertake full development of drug products or medical devices on a custom basis. Thanks to our highly trained on-site dedicated R&D teams with dedicated pilot plants, we have 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
- 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