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Brief Analysis on Blow-Fill-Seal (BFS) and Its Applications

At present, BFS technology is recognized as an energy-saving and environmentally friendly sterile process with high added value of products. BFS sterile filling production line has been well used in the production of sterile drugs, sterile functional foods and sterile cosmetics. This paper briefly introduces the concept, process layout and sterile preparation system of blow-fill-seal (BFS) sterile filling production line, and analyzes the particularity of BFS sterile production line in the aspects like risk prevention and practical application.


BFS sterile filling production line, which consists of a set of sterile preparation systems and a BFS sterile filling machine, is a relatively complete sterile filling production line. This production line has the full-line CIP, SIP functions and works under the protection of positive pressure, air tightness and laminar flow. Container manufacturing, product filling, and container sealing (blow – fill -seal) are all done under the sterile protection of a Class-A air shower, which can effectively prevent all kinds of pollution and cross contamination that may occur during the process. Temperature, pressure, time / speed and other process parameters during the process can be monitored online and recorded in real time, which fully meets the requirements of sterile process. As the BFS sterile filling production line has strong sterility guarantee ability, no preservatives need to be added to products, which can achieve “non-final sterilization”. What’s more, products are of high inherent quality and safety.

Process Layout of BFS Sterile Filling Production Line

Both types of devices can meet the requirements of sterile filling. BFS has two layouts: black and white partitioned layout and non-partitioned layout.Black and white partitioned device requires larger size because of the need to consider blocking the device at two different levels. Its advantage is to isolate the motor, pump, hydraulic and other parts that are prone to pollution sources in the general area. These isolated parts will also cause unavoidable pollution problems such as water and hydraulic oil during disassembly and maintenance, so the pollution in the filling room can be reduced to the maximum extent.

The black and white non-partitioned layout integrates some motors, hydraulic pressure, pumps and the like of the device under the device, so it’s relatively small. Its disadvantage is that particles will be generated during the work of these parts, which will cause the particles in the room to be high. Besides, the device parts are stacked too tightly, which will cause inconvenience to subsequent daily maintenance.


                 BFS Layout

In the BFS production process, although the plastic granule silo can be placed in the general area (control clean area), the pollution prevention of plastic granules is also very important. It is recommended to store the silo

in a separate small room and use a dust-proof hopper with a lid. Except for regular feeding, personnel should not stay in the room to avoid inhaling dust and foreign materials.

Sterile Management in the Production Process of the BFS Device

A detailed SOP should be done, including daily production, CIP, SIP and troubleshooting.  BFS device is highly integrated. After the device works, it can automatically work if it does not break down. When the device is turned on, personnel should seldom enter the filling room to make it as unmanned as possible.

For this reason, it is necessary to monitor the key areas of the device and deal with it in time when the device breaks down.

In the CIP / SIP process, great attention should be paid to the effect of cleaning and sterilization and the integrity test of each filter element. Replace hoses and seals regularly, perform leak detection on pipeline valves, and find damaged hoses and seals in time. When the dosing system transfers the chemical liquid to the BFS system, it is recommended to use a pressure pump or an easy-to-clean pump. When the product is suspension, whether the hardness of the liquid granules will affect the mechanical seal of the pump should be considered. Measures of isolation and back pressure elimination should be taken at the main drain to prevent back pressure in the drainage pipeline from causing unqualified BFS cleaning and sterilization and reverse pollution.

As the BFS filling area isolates the pollution in the room by a positive pressure air curtain, the sterility detection and control of Class-A air shower should be done. In addition to the various data measurements, attention should also be paid to the status of the Class-A fan and whether its blades and bearings are abraded and have debris, which may damage the filter element, and the good working condition of the fan can also greatly reduce the load of the Class-A filter element.

Application of BFS in the Production of Sterile Drugs

Compared with the traditional sterile production process, the BFS sterile filling process in the production of sterile drugs has the biggest advantage that the entire product production process is automatically controlled by the on-board computer program and according to the verified process program, with few human interventions and strong sterility guarantee ability. Each key station of the production line has a strong sterile guarantee function, which will be less affected by external environmental fluctuations and can effectively control and prevent various risks that may occur. In the production of sterile drugs due to sound regulations and mature technology, products can achieve “aseptic production and use”.

 

Application of BFS in Food and Cosmetics Production

BFS sterile filling technology was initially applied to sterile food production. It’s currently limited by the production process in the domestic market. Many functional foods and cosmetics are not produced by the sterile process, so they all contain preservative ingredients to avoid spoilage. The preservative principles of preservatives are to prevent or eliminate microbial contamination, inhibit the growth and metabolism of microorganisms, and kill microorganisms. In terms of the preservative principles of preservatives, preservatives are harmful to human tissues. Food and cosmetics produced by the BFS sterile process do not need preservatives. It is particularly suitable for the production of plant extracts with homology of medicine and food, such as ginseng extracts; single-use small packages of sterile cosmetics are accurately measured and easy to use and carry and can also prevent pollution and cross contamination during use, such as various extracts and sterile masks in cosmetics.As some cosmetics and foods are relatively thick and cannot be sterilized and filtered, before products enter the BFS device, appropriate methods should be used to ensure their sterility.


In short, BFS sterile filling process is currently recognized as an energy-saving and environmentally friendly sterile filling process with strong sterile guarantee ability, high technical content, production efficiency and product added value. The special functions of BFS sterile filling process and products determine that it will gradually replace the traditional “wash-fill- seal process” and become the inevitable development trend in production of sterile products.

一级黄色片。