■ Product Description
The BFS is a dedicated state of the art system, enabling primary packaging of bulk pharmaceutical solutions into plastic containers of polypropylene or high density polyethylene or low density PE, using a Blow-Fill-Seal (BFS) technology. The BFS are performed automatically in a single machine under a controlled environment (sterile filtered air-shower).
● Extrusion of plastic granulate into a parison at high temperatures
● Blow-moulding of parison into a container with sterile-filtered air
● Filling of sterile-filtered solution
● Hermetic sealing of filled container
This Filling unit assembly is composed of filling nozzles, the manifold with filling valves, the assembly for sterile air shower around the nozzles, the guide bars and the drive. The absence of hydraulic cylinders offers safe and clean assembly right above the filling nozzles, particularly suitable for clean environments.
■ Frequently Asked Questions
What is Blow-Fill-Seal (BFS) technology?
BFS is an automated manufacturing process where a container is formed, filled, and sealed in a single continuous operation under a sterile environment.
What materials can be used for the bottles?
The equipment is compatible with Polypropylene (PP), High-Density Polyethylene (HDPE), and Low-Density Polyethylene (LDPE).
Does the machine meet international medical standards?
Yes, our BFS equipment is manufactured according to cGMP standards and meets IEC 60204-1 safety requirements for machinery.
What is the typical production capacity?
The capacity varies by bottle size. For 1ml bottles, it can reach 3000 pcs/hour, and for 10ml bottles, approximately 1500 pcs/hour. Custom configurations are available.
What are the power and utility requirements?
The system requires a 3P/AC380V power source, oil-free compressed air at 8 bar, and cooling water between 8-12ºC.
How accurate is the liquid filling?
The filling accuracy is ≤ ±1.5% based on a 5ml volume using purified water as the medium.
CarniTe Machinery
