PrimaPharma will be adding a blow-fill-seal (“BFS”) machine to its manufacturing capacity during the first quarter of 2016. Using the BFS manufacturing technique, a container is formed, filled, and sealed in a continuous process, without human involvement, in a sterile enclosed area inside the machine. This technique works exceptionally well to aseptically manufacture sterile pharmaceutical liquid dosage forms.
The BFS manufacturing process provides several important advantages:
• More Accurate Dosing (Unit-Dose) — BFS allows high-volume, sterile packaging of product in liquid unit-dose form, helping to reduce human error.
• Preservative-Free — Aseptically packaging products eliminates the need for preservatives.
• Contamination Prevention — Contamination rates in the BFS process are much lower than in many other forms of packaging. The FDA considers BFS to be a superior form of aseptic production.