French SEAC Company recently introduced a new type of RABS isolation device (Restricted Access Barrier System) to optimize conditions for aseptic filling of milk and beverages in the sterilization or sterilization zone. It is understood that with this device, 72 hours of continuous filling can be produced without the need for disinfection procedures in the middle, so that productivity can be improved while ensuring safety.
Compared with the traditional isolation device, the device is improved in three aspects: one-way flow, barrier area, and easy access. First of all, unlike traditional isolators, the RABS device is not completely enclosed, but is an aerodynamic barrier caused by positive pressure in the operating room and protects the sterile vessel. The flow direction of filling is vertical one-way circulation, and the circulation speed can be controlled so that the air can continuously circulate and update. Through the joint use of the two technologies, the presence of particulate matter in the operation room can be eliminated and contamination from the outside can be prevented. While avoiding complete containment, continuous air loops prolong the time for aseptic conditions, allowing continuous production for 72 hours with no need to stop work for decontamination.
In addition, 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 just like an auxiliary protective barrier between the operator room and the rest of the shop, facilitating the cleaning and maintenance of the machine.
In addition, the aseptic operation room can only be accessed through the glove box provided at the critical part of the filling machine during production. However, all other parts - the processing unit of the product, the entry point of the production line - can be accessed through an external door, and the entering personnel do not have to wear the clothes of the sterile room type. 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 its own isolation device, it referred to the definition established by the International Society for Pharmaceutical Engineering (ISPE) for the Food and Drug Administration (FDA).
Source: Adsale Network
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