Blow Fill Seal (BFS) Production Lines
A single-step, lights-out approach to sterile drug production
At Nephron, Blow-Fill-Seal technology is the heartbeat of our sterile manufacturing platform. By forming the container, filling it with drug product, and hermetically sealing it—all on the same machine cycle inside a Class 100 (ISO 5) environment—BFS virtually eliminates human touch and airborne contamination, setting a new benchmark for patient safety.
How BFS works—inside every five-second cycle
| Stage | What happens | Built-in safeguards |
|---|---|---|
| **1 | Extrusion** | Pharmaceutical-grade resin is melted and extruded as a hollow tube (parison). |
| **2 | Blow & Mold** | A precision mold closes around the parison and sterile air inflates it into the exact vial or ampoule shape. |
| **3 | Aseptic Fill** | A stainless-steel mandrel descends, delivering the pre-filtered drug formulation into the newly formed container. |
| **4 | Seal** | The mandrel retracts and the container is fused shut, locking in sterility. |
| **5 | Cooling & Ejection** | Units cool, release from the mold, and transfer smoothly to downstream inspection. |
End-to-end automation—beyond the clean room
- Hot-stamp printing adds lot number and expiry without touching the drug pathway.
- Punch & re-grind system trims excess plastic, then recycles it for future production—up to 100 % of scrap reclaimed.
- Wilco 100 % leak detection subjects every vial to vacuum decay testing, guaranteeing container closure integrity before it leaves the line.
- Robotic tray loading, palletizing, and laser-guided vehicles (LGVs) move finished product directly to climate-controlled warehousing—operator-free, error-free.
What we can make on our BFS lines
| Therapeutic area | Typical fill sizes | Example products |
|---|---|---|
| Respiratory (unit-dose) | 0.5 mL – 5 mL | Albuterol, Ipratropium, Budesonide |
| Injectable (Parenteral) | 0.5 mL – 20 mL | Morphine, Fentanyl, Heparin flushes |
| Ophthalmic | 0.3 mL – 1 mL | Preservative-free saline, specialty eye drops |
| 503B Outsourcing | Custom syringes & bags | Surgery-center anesthesia cocktails, compounded antibiotics |
Why clinicians & partners choose Nephron BFS
- True asepsis – container never exposed to ambient air after formation.
- Speed & scale – high-throughput lines run around the clock, matching surge demand without compromising quality.
- Versatility – rapid tool-change capability lets us pivot between vial sizes and dosage forms in hours, not days.
- Sustainability – closed-loop plastic recycling and energy-efficient servo drives shrink our carbon footprint.
- Regulatory confidence – >20 years of FDA audits with zero major findings on BFS operations.
Quick stats
- Lines in operation: Multiple parallel BFS suites dedicated to commercial generics and 503B compounded products.
- Sterile boundary: ISO 5 core with walkable ceiling for HEPA change-outs—no production downtime for maintenance.
- Downstream automation uptime: 99 %+, verified by integrated OEE dashboards.
From emergency respiratory therapies to ophthalmic precision doses, our Blow-Fill-Seal department delivers contamination-free medicines with unmatched consistency—24 hours a day, 365 days a year.