Analysis of BFS Aseptic Filling Production Line

2023-07-26

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Marya

1. Sterile reparation system of BFS aseptic filling production line

The sterile preparation system of BFS aseptic filling production line is an important component of the BFS sterile filling process. To meet the needs of process diversity, a system should be designed that can work together with BFS machines and independently perform CIP/SIP, and can be designed for automatic and manual operations according to process requirements. It is necessary to scientifically and reasonably set the collection points and methods for various monitoring data in the production process, and verify the authenticity and completeness of each data through verification.

During the entire sterile preparation process, the basic principles of aseptic guarantee of laminar flow protection, airtight and positive pressure operation must be strictly followed. The process pipeline design between the mixing tank and the sterile storage tank should have strict sterile boundary points; Process water, compressed gas, and sterile clean steam must undergo sterilization filtration through a sterilization level filter before entering the preparation system; All sterilization grade filters must undergo "integrity testing" before and after use; The filter should be installed in the order of pre-filtration, decontamination level filtration, and sterilization level filtration; Some sterilization grade filters can be cleaned and tested offline, sterilized online, and undergo integrity testing immediately after use.

Due to the particularity of BFS machines (filling volume control using time/pressure method), in order to ensure the effectiveness and filling accuracy of BFS aseptic filling production line CIP/SIP, it is best not to use infusion pumps that are difficult to clean and sterilize for material transportation. Clean compressed gas should be used as the material transportation power. The agitator in the tank shall be a suspended Magnetic stirrer that can ensure CIP/SIP effect; The cleaning ball inside the tank should use a 360 degree strong cleaning ball with good cleaning effect; The turbulent flow velocity generated by the process pipeline in the system should not be less than 1.5-2 m/s, and the Reynolds coefficient should be controlled between 3000 and 9000 in practical operation; The process pipelines installed in parallel in the system should have a certain slope and minimize their length as much as possible; The tank body shall not be equipped with a Level sensor that is difficult to clean and sterilize, and the accurate weighing system shall be used for measurement; Replace safety valves that are difficult to clean with explosion-proof membranes that can be used for CIP/SIP.

(1)The sterilization level filter should be installed at the highest point of the system.

To ensure the reliability of the sterile preparation process, prevent safety hazards, and ensure the authenticity and completeness of various parameters during the process, an online monitoring system (data can be transmitted to the BFS machine computer system for storage) should be installed in the preparation room to online dynamic monitor the temperature, pressure, measurement, and pH values of the entire production process.

To prevent system pollution caused by "back pressure" in the discharge of SIP steam, CIP water, and compressed gas, the sterile preparation system and BFS machine should have their own independent discharge systems. The installation slope of the flat discharge pipeline shall not be less than 3 ‰, and an evacuation device with air blocking function shall be installed at the main discharge outlet to eliminate the risk of system back pressure.

When using BFS aseptic filling production line to produce concentrated food and cosmetics, due to the high molecular weight of active ingredients in many products, it is not easy to use sterilization and filtration processes. Therefore, a "ultra high temperature instant sterilization" device can be installed between the mixing tank and the sterile storage tank to sterilize and cool the materials before entering the sterile storage tank. The production line does not install or select suitable filters before CIP/SIP. The process combination can not only complete the sterilization of materials in a very short time, and retain the active ingredient and original flavor of materials to the maximum extent, but also prevent the "final sterilization" of products after filling and sealing, causing deformation of plastic containers.

2. Application of BFS aseptic production filling line

The BFS machine can automatically complete CIP/SIP for all material pipelines under computer program control. The screw extruder and billet extrusion head form plastic particles into tube billets at a high temperature of 170-230 ℃ and a pressure greater than 350 bar. The three processes including container production, product filling, and container sealing (Blow Fill Seal) are all completed at the same sterile workstation under the protection of the airborne A-level air shower room. Under normal circumstances, the equipment operates automatically under the program control of the onboard computer, and there is no need for personnel to operate in the filling room, maximizing the prevention of potential pollution and human errors. The various process parameters of the entire production process are fully stored in the onboard computer system, which can be viewed at any time but cannot be changed. It can be said that BFS aseptic filling production line is currently the most capable and intelligent sterile filling production line.

(1)The application of BFS technology in the production of sterile drugs

In the production of sterile drugs, BFS aseptic filling process has the biggest advantage over the traditional aseptic production process, which is that the entire production process of the product is automatically completed under the control of the onboard computer program according to the verified process program, with little human intervention and strong aseptic support capability. Each key workstation on the production line has strong aseptic protection functions, which are rarely affected by external environmental fluctuations and can effectively control and prevent various risks that may arise. In the production of sterile drugs, due to sound regulations and mature technology, products can achieve "sterile production and sterile use".

(2)The application of BFS technology in food and cosmetics production

The BFS aseptic filling technology was initially applied in the production of sterile food. At present, due to production process limitations in the domestic market, many functional foods and cosmetics are not produced using sterile processes. To prevent product spoilage, functional foods and cosmetics all contain preservatives. The anti-corrosion principle of preservatives is to prevent or eliminate microorganism pollution, inhibit microorganism growth and metabolism, and kill microorganisms. In terms of the anti-corrosion principle of preservatives, preservatives are harmful to human tissues. Using BFS aseptic production filling line to produce food and cosmetics does not need to add preservatives, which is particularly suitable for the production of plant essence products such as medicine and food homology, such as ginseng essence; Disposable small packaging sterile cosmetics not only have precise measurement and convenient use and portability, but also can prevent pollution and cross contamination caused during use. Such as various essence in cosmetics, sterile facial mask, etc.

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