Brief Introduction of BFS Aseptic Production Technology
What Is BFS Technology?
I.Introduction of BFS technology
BFS technology, that is Blow, Filling, Seal, BFS for short, has developed as early as the 1960s.
BFS is a special aseptic packaging technology. It can operate continuously, changing medical polyethylene (PE) or polypropylene (PP) particles into containers, and it conducts the filling and sealing process automatically, which can achieve rapid continuous circular production. It integrates several manufacturing processes in the same equipment and completes the whole process including blowing, filling and sealing of plastic containers in a single process under an aseptic state, which can effectively ensure the safety of products.
The equipment has the advantages of low production cost and management cost, good sterile stability, the high intrinsic quality of finished products, and a small probability of product cross-contamination. So it can be widely used in the final sterilized products of plastic packaging, aseptic products and other production fields.
From the microbiological point of view, this production technology belongs to the closed container production process. Molding and sealing integration can minimize human intervention and achieve the result of an aseptic operation without intervention; Environmental exposures are also minimized, thus guaranteeing a high level of sterility.
The BFS technology has been used worldwide for about 50 years, and the contamination rate can be under 0.1%. The pollution rate of the blowing and potting system combined with the summary and analysis of the media filling data is 0.001%.
what is BFS Production Process and Aseptic Guarantee Principle？
II. BFS Production Process and Aseptic Guarantee Principle
（1）BFS Production Process
The BFS production process (Figure 1) consists of three processes to produce sterile products：
First step—-Sqeezing
Under the temperature of 170 ~ 230 ° C, the pressure of 350 bar the plastic particles will go through the rotating screw continuous extrusion to form a tube blank, by the sterile air protection of the tube blank through the mold, when the tube blank reaches the correct length, the main mold closed and seal the bottom of the tube blank, the knife cut the tube blank, the top of the tube blank is opened to maintain clamp positioning, sterile air continues to protect the open tube blank in the mold.
Second step—-Aseptic Filling
The mold is quickly transferred to the blowing/filling/loading station, and the sterile air in the class A air shower device that comes with the equipment protects the blowing, filling and sealing stations. The blow-fill needle machine quickly descends to the neck of the container, and blows clean compressed air into the container (small container molding using the vacuuming method), the container then will be shaped according to the shape of the mold; The liquid medicine measured by the time-pressure method is immediately filled in the container which removes the sterile air inside the container.
Third step—-Sealing
When the blow-fill machine retracts, the head die closes so that the bottle is sealed. After sealing, the mold is opened and the bottles that have been formed, filled and sealed are sent out of the machine. The equipment begins the next production cycle, which is repeated in turn.
（2）Principle of Sterility Protection for BFS Production
The molding method of the container is to melt the plastic particles and blow molding under high temperature and high-pressure conditions. Throughout the process, sterile air protects the inner wall of the mold, ensuring the sterility of the vessel itself.
The container opening time is short, which makes the liquid exposure time shorter. A filling cycle takes less than 14 seconds, and the opening time of the container is about 2 to 4 seconds from filling to the sealing time of the container, that is, the liquid exposure time is shorter.
Before filling the BFS equipment , after CIP/SIP, the pipeline through which the liquid flows reaches the cleaning standard, F0 value≥8, and the system is always in a positive pressure state, abnormal, timely alarm prompt and lock the operating procedure, effectively avoiding external pollution and ensuring the safety of the liquid.
BFS equipment itself is equipped with an A-level air shower device. Besides A-level, it is equipped with a touch screen, PLC and other control devices to control the BFS system. Through these control devices, the BFS system itself can not only operate with a high degree of automation but also be fully connected with its upstream and downstream production systems to realize the automatic and linked operation of multiple production systems and minimize the interference of aseptic production by machine operators providing a higher level of sterility assurance.
what is Advantages of BFS production process in small volume injections？
Due to the unique advantages of plastic ampoule injections, such as the particle is significantly less than that of glass injections, plastic ampoule injections are gradually replacing glass filling bottles in recent years. From the production practice, the BFS production process has the following advantages:
The BFS process is an aseptic packaging process. During the production process, the cooling and forming of the bottle are carried out almost at the same time. The temperature of the product only rises slightly at the beginning of filling, and terminal high-temperature sterilization is not required. The active ingredients and PH will not change. No new substances will be generated. The insoluble particles will be greatly reduced, and the product has the high internal quality and good stability.
The BFS process is an aseptic packaging process. During the production process, the cooling and forming of the bottle are carried out almost at the same time. The temperature of the product only rises slightly at the beginning of filling, and terminal high-temperature sterilization is not required. The active ingredients and PH will not change. No new substances will be generated. The insoluble particles will be greatly reduced, and the product has the high internal quality and good stability.
BFS equipment makes the container under aseptic conditions, the container does not need
to be cleaned and sterilized, saving process water and energy; the plastic container is not fragile, does not need excessive packaging, low production cost,and saves transportation cost and plant area.
Compared with the traditional glass bottle technology, BFS technology does not need to clean and sterilize the bottle and rubber stopper and reduces human factors. The PP and PE materials used by BFS equipment for bottle making are of high intrinsic quality and more suitable for drug packaging.
Conclusion
The production of sterile preparations carried out by Blowing, Filling and Sealing (BFS) technology is carried out in a C-class clean room, the blowing, filling and sealing station works under the A-class air shower device that is equipped with the equipment, and the plastic container is filled and sealed under the protection of sterile air, that is, there is no possibility of secondary pollution after the liquid filling.
Due to the automatic control of online cleaning and online sterilization technology added to the equipment, the BFS equipment minimizes the number of insoluble particles in the product and controls the contamination of microorganisms and heat sources during the production of sterile preparations; s technology like BFS that can achieve automatic and segregated operation will be the future development direction of sterile preparation production.