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helenzhang@hxbiotech.cn
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Guangzhou Hengxu Biotechnology Co., Ltd
The design of aseptic filling lines should consider various factors such as the following
Date: 2022-10-12Read: 8
The aseptic filling line consists of a set of aseptic preparation systems and a BFS aseptic filling machine, and is currently a relatively complete aseptic filling production line. This production line has full line CIP/SIP function and operates under positive pressure, closed, and laminar flow protection. Container production, product filling, and container sealing are all completed under the sterile protection of air shower, which can effectively prevent various types of pollution and cross contamination that may occur during the process. Temperature and pressure during the manufacturing process pH、 Process parameters such as weight, time/speed can be monitored online and recorded in real-time, which meets the requirements of aseptic processes. Due to the strong sterile assurance capability of BFS aseptic filling production line, no preservatives need to be added to the products, which can achieve "non final sterilization". The internal quality of the products is high and the safety is good.
The principle of using aseptic filling line:
The entire aseptic preparation process must strictly adhere to the basic principles of laminar flow protection, closed and positive pressure operation for aseptic assurance. 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 grade filter before entering the preparation system; All sterilization grade filters must undergo "integrity testing" before and after use; The filter settings should be installed in the order of pre filtration, sterilization level filtration, and sterilization level filtration; Partial sterilization grade filters can be cleaned and tested offline, sterilized online, and undergo integrity testing immediately after use.
The design of a sterile filling line should consider various factors, including:
1. Meet the requirements of aseptic operation processes and products.
2. The use of RABS or isolation manipulator technology is an important guarantee for aseptic operation processes. Strict isolation measures are required for the packaging of highly allergenic, toxic, anti-tumor drugs, hormones, or highly active drugs.
3. Reduce manual intervention to lower potential contamination risks during aseptic production processes.
4. It is required to protect both the operators and the room environment from possible pollution caused by the product, as well as to protect the product from pollution caused by people and the room environment.
