What is BFS technology?
BFS technology is a type of primary packaging that is commonly used in the pharmaceutical industry. It is a packaging process that allows production of a filled container starting from the plastic granule, happening inside one machine only. In one continuous operation, the container is formed, filled and sealed in a controlled environment, in only a few seconds.
The process starts from the plastic, which is molded and extruded in one blown cylinder called “parison”. The mold closes on the parison to form the bottle or vial, which is subsequently filled with the desired product and finally sealed. The entire process remains in grade A environment and is thus fully sterile, even if the machine can be placed in a class C/D cleanroom.
How is BFS technology applied to Pharma Packaging?
BFS technology is often used in pharma packaging because it provides a high level of protection for the product. This process is advantageous because the containers produced on BFS machinery are already aseptic when delivered as the entire process takes place under sterile air shower in grade A. However, if regulations require the product to be terminally sterilized, it can easily withstand terminal sterilization at 121°C as per normal procedures.
This technology is very flexible and allows for a variety of container shapes and sizes, to suit several applications like IV solutions, ophthalmics, injectables, sprays, biologics, enemas and even vaccines. It applies to Small Volume Parenterals, Large Volume Parenterals and also Prefilled Syringes.
The benefits of BFS technology for pharmaceutical companies
BFS technology provides a number of benefits for pharmaceutical companies.
High quality packaging at a very reasonable cost: this is the main reason BFS technology is fast replacing older manufacturing technologies in the pharmaceutical world. Plastic bags, glass bottles or plastic bottles produced in two steps are very common technologies for the aseptic filling of solutions. However, a comparison quickly shows that Blow Fill Seal containers prove to be the least expensive. Main factors involved are a lower cost of the facility, a shorter supply chain, a clean room that only needs class C or D, and the lowest cost of primary materials and operations.
On top of the increased protection from contamination, process automation and cost efficiency are also enhanced by the BFS process. Cleanroom area and personnel requirements are drastically reduced, as well as cost of logistics and of inventory because it eliminates the need to provide and pre-sterilize a preformed container.
BFS containers are made of plastic and are light-weighted, easy to carry and store, while at the same time they grant a long shelf-life. Containers can be molded in a wide variety of shapes and volumes and can be either rigid or very flexible to make them squeezable. Custom-tailored shapes for the containers include the possibility to adjust the head shape to the product application.
The BFS production process is fast and reliable, totally automated and designed for high performances, thus being particularly indicated for mass production. Particularly for Small Volumes, BFS grants the lowest cost of fill and finish in the market compared to glass vials or pre-formed plastic ampoules.
The challenges of BFS technology for pharmaceutical companies.
BFS technology is a process used to create sterile, hermetically sealed containers from plastic, which are usually PP, PE or HDPE. Compatibility of the product with such thermoplastic resins is usually not an issue. However, some pharmaceutical formulations like vaccines or biologicals can be sensitive to temperature, and this might seem a challenge as BFS containers reach high temperatures while being formed. This challenge is easily overcome with slight modifications to the cycle and special arrangements on the machine, to ensure that the product being filled is not exposed to high temperature during primary packaging.
A more realistic challenge would be to change the way pharmaceutical companies tend to be linked to traditional filling methods, like conventional prefilled syringes, glass vials or soft bags. It is important to consider that the BFS process is recognized by international regulatory agencies as an advanced aseptic manufacturing technique that potentially eliminates the need for terminal sterilization.
