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Process Layout of BFS Aseptic Filling Production Line

2023-07-07

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Marya

The process layout of BFS aseptic filling production line should not only meet the requirements of aseptic process, but also fully consider the particularity of BFS aseptic filling production line.

The process layout of BFS aseptic filling production line should not only meet the requirements of aseptic BFS filling machine process, but also fully consider the particularity of BFS aseptic filling production line.

According to the requirements of aseptic BFS filling machine process, a shower room should be set up in the rear section of the main changing room. As the filling area is a C-level clean environment, it should be managed according to the A/B level clean environment (personnel should dress in accordance with the style of the A/B level clean area), and the filling area and preparation area should have separate an access road of pedestrians. For the production of antibiotics/hormone products, independent exit channels should be designed in the preparation room to prevent cross contamination of the clean dressing room caused by material dust; The preparation area should have an independent filter cleaning and testing room, so that after sterilization and filtration, the filter can be integrity tested at once.

 

The buffer room of the logistics channel should be equipped with sterilization ultraviolet lights to reduce the pollution caused by microorganisms carried by packaging materials in the preparation area. Material weighing should be carried out in a negative pressure weighing room with A-level laminar flow protection, so that exposed materials are always under A-level laminar flow protection, while protecting operators and the environment from material pollution and cross contamination. The laminar flow in the weighing room should be designed with air flow method for indoor air intaking and self circulation filtration to avoid affecting the pressure difference between adjacent rooms.

 

1. Air flow organization in negative pressure weighing room

 

Interlocking devices and observation windows should be reasonably set up between each functional room to prevent the occurrence of "channels" during the production process, while also facilitating observation and communication during the production process, and minimizing pollution caused by operation, management and other factors to the clean production area. In BFS filling machine process, it is very important to prevent plastic particles from being contaminated by dust during the supply process, and an independent plastic particle supply room should be established. When using vacuum method to transport materials, an air filtration device should be installed above the plastic particle supply box to avoid inhaling dust and particles that may affect the quality of the container; In seasons and environments with large temperature differences, plastic particles should enter the temporary storage room 24 hours in advance to avoid the impact of temperature and humidity on the container.

 

 

Implement CIP/SIP, the aseptic preparation system that operates under closed and positive pressure. The mixing tank and sterile storage tank can be located in the same room, but the sterile boundary point must be strictly defined and must be divided by a sterilization grade filter instead of a decontamination grade filter. Process treatment rooms can be added in adjacent rooms of the preparation room according to aseptic BFS filling machine process requirements, which can meet the process treatment needs before mixing (such as ultrafiltration equipment, homogenizer, etc.) and prevent pollution to the preparation room. Due to the fact that the filling area of  BFS aseptic filling production line is managed as an A/B level clean area, there shall be no equipment washing and hygiene cleaning rooms, and no drainage floor drains. The tools and instruments that need to be cleaned should be transferred to the washing room in the preparation area through an independent one-way transfer window (room) for cleaning. The cleaned tools and instruments should be sterilized in a double leaf sterilization cabinet and then transferred to the filling area. Before use, they should be stored under A-level laminar flow. The transfer window (room) should have ventilation and ventilation function, with pressure difference protection at both ends, and the logistics routes before and after sterilization should not overlap.

 

2. Laminar flow protection of BFS filling machine and water collection tank in the auxiliary machinery room

 

The BFS machine of BFS aseptic filling production line must be installed in a "black and white partition", with the blowing, filling, and sealing parts installed in a C-level clean area according to the requirements of Specification, and the auxiliary parts installed in a regular production area. When implementing aseptic processes (producing non-terminal sterilized products), according to aseptic process requirements, A-level laminar flow protection should be installed above the filling area of the BFS machine (some equipment comes with laminar flow protection); The airborne air shower room should be designed to extract air under A-level laminar flow. When designing the air volume and pressure difference in the filling room, it is necessary to fully consider the pressure difference and air volume loss caused by the product channel and smoke exhaust fan. The discharge outlet of CIP/SIP water for BFS machines should be located in the auxiliary room of the regular production area, and air blocking and back pressure elimination devices should be installed.