Blow Fill Seal – BFS technology is the latest in Pharma product processing that allows pharma manufacturers to contain a drug product in plastic container, that take any shape and form. This process is specifically helpful to contain biological products that can face molecule degradation, when using conventional methods. Initially it was being used for liquid products and Large Volume Parental, but now it is also being considered and applied for injectable.
What is the BFS?
BFS is a technology in which a drug container is formed, immediately filled and sealed in a sterile environment. The entire process is completed in a single stage, in a single machine without taking the product at other location and machine.
The material of construction for the container is plastic, and requires plastic grain of sufficient size and shape to match the required physical characteristics of the container. The plastic grain is fed to the extruder section of machine that eventually converts it into the container.BFS is commonly used for primary packaging and has been recognized by major regulatory bodies around the world as a manufacturing process for sterile injectable.
BFS process
The BFS process is a continuous process within a machine and is completed in a single process. Let’s briefly explore this processes
Extrionus
It is the first stage of the process where molten plastic granules are extruded into a die mold of the desired container that enables the plastic to take the container shape.
It is executed at high temperatures that melts the plastic, and is pressed through a small orifice opening in the mold. The pressing enables the molten plastic to take the shape of continuous tube. At this stage, the die mold is open from the center
Blowing
The blowing is the second stage where the hot molten plastic is subject to pressurized sterile gas, and as a result, the hot molten plastic takes the shape of the mold. At this stage the basic physical appearance of the container take its shape.
The sterile gas can be any inert gas, such as nitrogen. Vacuum is also used in some machines to aid the blowing process
Filling
In the filling process product is filled into the molded plastic. Nozzles enter into the molded container usually from top to start filling, up to a specific level. To prevent contamination in the product, nozzles and openings are showered with sterile gas.
After liquid has been filled, nozzle retract back to their home position to for the next stage process.
Sealing
In this stage the mold is sealed. During this process, the plastic takes the shape of the container with the liquid inside. The resultant is a finished container that can be used as usual filled container.
De-flashing and scrapping
This is the last stage in the BFS process, where the excess plastic is scrapped from the container edges for container physical finish.
After this process, the containers are delivered outside the machine for collection and further stages.
Advantages of BFS
Let's discuss some advantages of BFS in the pharmaceutical industry
Less human intervention
Humans are the main source of contamination in Pharmaceutical industry. An effective way of reducing contamination is by restricting humans to perform routine operation and automating these processes. The BFS can effectively apply this phenomenon and can provide good protection against human contamination.
In the BFS machine, the process take place with the minimal human intervention. The container formation and filling process is performed in an enclosed environment that becomes unable for humans to interact with. Additional measures, such as showering with sterile gas and particle monitoring also increase the integrity of the process
No container defects
Containers defects are common in conventional processing and greatly contribute to the contamination. It also causes defect in product at different stages, some of them are described below
· During transp...
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