Advanced BFS Aseptic Filling Process

2023-11-21

original

Marya

The BFS process is more suitable for the production of thermosensitive drugs, biochemical preparations, vaccines, and other products. During the production process, the unique mold design ensures that the molding and cooling processes of ampoules are almost completed simultaneously. Although the temperature of the product slightly increases at the beginning of filling, it is not enough to affect the quality of the drug. The BFS aseptic filling process has many mature application cases in the production of sterile drugs in China, such as clindamycin phosphate injection, biochemical vaccines (not heat-resistant), benzyl alcohol injection (highly volatile), and large volume injections with special therapeutic effects.

1. Application of BFS Aseptic Filling Process——BFS Machine

2. BFS Sterile Filling Equipment——BFS Machine

At present, domestic equipment has made many innovations based on the introduction and digestion of European and American technologies, in accordance with GMP standards and sterile process requirements: the modular design of the equipment is "black and white partition", the filling part is in the A-level laminar flow zone under the C-level background, and the BFS process is completed at the same workstation under the A-level wind drenching protection; The auxiliary equipment, plastic particle supply section, and equipment maintenance are completed in the ordinary production area; Set up a control screen that can switch between the clean production area and the regular production area, and there are no operators in the filling room during production; The product is punched, printed, tested, and packaged outside the clean room, minimizing pollution sources in the filling room, and more in line with GMP requirements and sterile drug production requirements.
Equipment manufacturers can also provide personalized supporting equipment according to the different needs of users (from sterile preparation systems to leak detection, printing, packaging and other equipment, from small to large capacity models); The combination and personalized design of molds can meet the different needs of users to the greatest extent; Perfect after-sales technical services and fast accessory supply can relieve users' worries and reduce investment risks; Professional engineering and technical personnel participating in process design and employee training can help enterprises quickly transition to a mature stage. At present, nearly 10 domestic pharmaceutical production enterprises have chosen domestic BFS equipment, and domestic BFS equipment is also exported to countries such as India, Algeria, Afghanistan, Brazil, Cuba, etc.

3. Process flow of BFS sterile filling machine

The basic working principle of BFS equipment: The screw injection molding extruder of the machine heats and melts plastic particles, and forms a blank through the extrusion head supported by clean air; With the protection of A-level air shower and the help of the parison clamp, the parison enters the mold of the sealing unit and is processed into a container inside the mold under the action of clean compressed air and vacuum; The filling system injects the product into the container while exhausting the gas inside the container; The head mold of the sealing unit seals the container, and the mold unit opens. The robotic arm sends the product out of the filling room through the channel and into the ordinary production area. From this, the BFS production process can be summarized into three basic process flows.

(1)Extrusion Molding——BFS Machine

The injection molding machine and billet extrusion head squeeze the tube billet formed by extrusion and hot melting(170～230℃，3.5×107Pa)of plastic particles into the open mold. The parison cutter cuts the tube blank under the head mold. The main mold is closed, and while sealing the bottom of the container, the specially designed mandrel filling unit descends to the neck position of the container. Under the action of compressed gas or vacuum, the tube blank is made into a container, and the container is cooled by the circulating water system inside the mold.

(2)Filling——BFS Machine

By using a specially designed mandrel unit, the product to be filled is accurately measured and poured into the container (time pressure quantitative method), while the air inside the container is discharged and a "Ruhr interface" is formed at the neck of the container.

(3)Sealing, Mold Opening——BFS Machine

When the specially designed mandrel unit is retracted, the head mold is closed, the container is sealed. After sealing, the mold unit opens, and the product is transported out of the equipment by a robotic arm. The equipment starts the next production cycle, repeats in sequence, and runs in cycles. The product conveying process is completed by two robotic arms, which do not cross different levels of areas during operation.

Aseptic Filling Production Process for Vial Filling Machine

Exploring the BFS Aseptic Filling Process