8 Advantages of Aseptic BFS Machine Filling Technology
The production of aseptic pharmaceutical products has historically been the most demanding and risky pharmaceutical project. Many pharmaceutical companies are faced with the “dilemma” of changing the production process or abandoning the production of aseptic products that cannot be terminally sterilized.
Aseptic BFS filling process:
The emergence of the Blow Fill Seal “three-in-one” aseptic filling process (hereinafter referred to as the BFS process) should be marked by the BFS machine invented by German engineer Gerhard Hansen in 1962. The BFS machine can complete the CIP/SIP (online cleaning/online sterilization) of all material pipelines under the control of computer programs so that the three processes of bottle making, filling, and sealing are completed in the same sterile environment under the protection of Class A air shower.
The entire production control process is completed by the computer program according to the predetermined program. The possible risks (environment, temperature, pressure difference, etc.) in the process are monitored by the computer control system according to the set parameters. The parameters are completely stored in the computer and can be consulted at any time, but cannot be changed. This is the filling process with the strongest sterility guarantee capability at present.
The BFS Aseptic Filling Technology Process is Shown in Figure 1.
Introduction of the 8 detailed advantages you need to know about aseptic BFS machine filling technology.
1. Superior aseptic production environment design:
BFS machine is designed and installed according to the principle of “black and white partition”. The whole production process is controlled by the computer program, and the process parameters are stable and reliable. The filling area of the equipment is protected by A-level laminar flow, there is no operator in the filling room during production, and there is no pollution source in the production process. All process pipelines (including the preparation system) in contact with materials can realize CIP/SIP, and the blowing, filling, and sealing stations are protected by A-level air showers, and products are trimmed outside the filling room. One side of the product conveying channel is in the A-level laminar flow area and the other side is in the general production area, there is a pressure difference protection of not less than 40Pa, and the entire process has a strong aseptic guarantee capability.
2. Super cost-saving ability:
The BFS machine makes the container in the aseptic state without cleaning and sterilizing the container, saving the process water and energy.
3. High product quality and comprehensive economic benefits:
BFS machine adopts modular design, one piece of equipment is like a small factory, which can automatically complete the whole process and monitoring of blowing, filling, and sealing. The equipment occupies a small area and consumes less energy in the production process. Therefore, the comprehensive production cost of the BFS aseptic filling process is not higher than that of the traditional aseptic filling process, but the product quality and comprehensive economic benefits are much higher than the traditional aseptic filling process.
4. Ultra-high technical content and product added value:
BFS machines can use PP/PE2 materials according to the process needs, the comprehensive cost of plastic container production is low, and the product technology content and added value are high.
5. Computer control, safe and reliable results:
BFS machine can automatically complete CIP/SIP under computer program control, with reliable reproducibility and safe and reliable results
6. Suitable for the production of various forms of aseptic filling products:
BFS equipment can realize aseptic filling without high-temperature sterilization, and the product quality is stable. It can be applied to various forms of aseptic product filling and the production of various aseptic containers only by changing different molds.
7. Aseptic production, aseptic use, cost savings:
The filling machine of BFS equipment forms a “Luer interface” structure at the bottleneck while the product is being filled. The “Luer interface” can be tightly connected with the syringe. When the solution is extracted, the external air will not enter the container, and products can realize aseptic production, aseptic use, and good safety performance. Plastic packaging waste is easy to handle and will not pollute the environment.
BFS’s aseptic filling process has a history of nearly 50 years. Due to the advantages of a strong sterility guarantee in the process of production and use, it has become a trend to replace the glass ampoule production process of washing, filling, sealing, and sterilization and the glass bottle infusion production process with the BFS aseptic filling process. Flexible packaging of aseptic products has irreplaceable advantages in special fields such as combat readiness and disaster relief.
8. The BFS process is more suitable for the production of heat-sensitive drugs, biochemical preparations, vaccines, and other products.
During the production process, the unique mold design makes the forming and cooling process of the ampoules complete almost simultaneously. Although the temperature of the product rises slightly at the beginning of filling, it is not enough to affect the quality of the drug.