BLOW FILL SEAL: THE PROCESS
Extrusion of plastic granules in the form of a hot hollow pipe of molten plastic called “parison”.
While the mould closes over the parison, the container gets formed and acquires the desired shape due to pressure difference between inner and outer side of the parison, which can be created either by blowing sterile filtered compressed gas (air, nitrogen or any other inert gas) or by applying the vacuum on the mould cavities.
The filling nozzles enter from the top of the container and inject the product in the formed containers. During this step, the filling nozzles and the opening of the containers are protected by a shower of sterile filtered air to avoid contamination. The performance of sterile air shower can be continuously monitored by a particle counter.
After filling, the top of the parison, which is still hot, gets pressed between the mould to seal the container. The result is a hermetically sealed containers every 10 to 15 seconds.
The last step is removing the flash (excess polymer or scrap) or trimming, and delivering the containers outside the machine.
The BFS process does not require any pre-formed containers, as it starts directly from the polymer granule that is fed to the machine, where it is melted and extruded, thus eliminating the need for complicated or costly upstream equipment or particular storage space.
BFS technology is nowadays the preferred primary packaging solution not only by pharmaceutical companies and healthcare providers, but wherever there is the need to package products at minimal cost ensuring contamination free packaging.
BFS process takes place under sterile air shower in grade A, so the final product is already aseptic. However, if regulations require the product to be terminally sterilized, it can easily withstand terminal sterilization at 121°C as per normal procedures.
FROM POLYMER TO ASEPTIC PRODUCT IN FEW SECONDS
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