French company Serac has just introduced a new type of RABS isolator to the market to optimise the conditions for aseptic filling of milk and beverages in sterile or sterile areas. With this device, continuous filling can be performed for 72 hours, eliminating the need for decontamination in the middle, and thus increasing productivity while ensuring safety. 

Compared with traditional isolation devices, the device has three major improvements:

One-way circulation

Unlike conventional isolators, the RABS device is not completely enclosed, but is an aerodynamic barrier that is acted upon by high pressures in the operating chamber, which protects the sterile vessel. The circulation direction of filling is vertical one-way circulation, and the circulation speed can be controlled so that the air can be continuously circulated and updated. Through the joint use of the two technologies, the presence of particulates in the operating room can be eliminated and contamination from the outside can be prevented. 

While avoiding complete containment, continuous air circulation extends the time of aseptic conditions and allows continuous production for 72 hours without the need to stop work for decontamination. 

Second, the barrier area

The sterile area is surrounded by a barrier area, and the barrier area is also under the control of one-way circulation. The barrier zone is like an auxiliary protective barrier between the operation room and the rest of the workshop, facilitating the cleaning and maintenance of the machine. 

Third, easy to enter

The heart area of ​​the machine, aseptically, can only be accessed through the glove box provided at the critical part of the filling machine during production. However, all other parts, such as the processing station of the product and the entry and exit points of the production line, can be accessed through an external door, and the operating personnel do not need to wear sterile clothing. All entries and exits in the barrier area are registered to ensure that the operation has good tracking performance. 

The new RABS isolation device was first designed to meet the requirements of the pharmaceutical industry. When Serac designed the isolation device, it referred to the definition established by the International Productivity Promotion Association (ISPE) for the US Food and Drug Administration (FDA). There are 7 criteria in this definition:

1 Hard partitions to form a physical separation between production and operations personnel. 
2 One-way circulation, ISO 5 standard. 
3 Gloves and automatic devices are used to prevent personnel from entering during filling. 
4 The transmission system of the equipment should be able to avoid exposing the product to an unclean environment. 
5 The surface is highly disinfected. 
6 Environment meets ISO 7 requirements. 
7 The intervention is minimal, and it is necessary to carry out the decontamination treatment after intervention; the door must be locked, with an unlocking registration system; with positive pressure; the environment meets the 1SO 5 requirements. 

Founded in 1969, Serac Inc. of France specializes in the production of liquid and semi-liquid filling and packaging machinery and packaging production lines. The company produces equipment for the food, industrial, chemical and hygiene (perfume, beauty and pharmaceutical) markets.

Source: China Electromechanical Enterprise Network

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