The Restricted Access Barrier System (RABS) of a duplex rubber stopper (aluminum cap) cleaner is a new way for aseptic unloading and transferring of rubber stoppers (aluminum caps) that completely meets new version GMP requirements.

The RABS of a rubber stopper (aluminum cap) cleaner is installed at the unloading side of the machine in order to ensure that rubber stoppers (aluminum caps) are sealed and their re-contamination is prevented during unloading and transferring. This system is installed in a cleanroom of B grade sterility.

When a rubber stopper (aluminum cap) cleaner unloads through a RABS, an unloading hopper and an aseptic PE bag should be put in the buffer area to go to the unloading area. When the hopper has been transferred to the unloading end and trained on the aseptic bag, the machine starts unloading. An automatic sealing machine seals the PE bag when a specified number of rubber stoppers (aluminum caps) have been poured into it. After that the PE bag is transferred to the buffer area, covered with a protecting bag, and removed from the RABS (the material of protecting bag can be PE or others). Now the operator may transfer it to the buffer area of the RABS of a racking or capping machine, take off the protecting bag, and directly pour rubber stoppers (aluminum caps) from the PE bag into the loading hopper in the loading area. All operations should be carried out in the RABS. The operator should work wearing gloves.

Aseptic PE bags are very convenient for manual transfer. Their size must be reasonably designed. The structure of PE bag sealing machine must be convenient for gloved operation in the RABS. Therefore, the only way is to use automatic sealing equipment.

The technical key of the aforementioned method is the PE bag sealing machine, which must be totally automatic due to the severely restricted operational flexibility in the glove box.

The above-mentioned operations not only meet the requirements of loading and unloading in A grade sterile area, but also turn the complicated transfer process to a very simple one. The packaging material factory is responsible for the asepsis and other performance of PE bags, and the sealing machine factory is responsible for the sealing of PE bags, making the whole validation process easy and convenient. This is the most popular method at present.

In addition, if the system is configured with on-line detection devices for dust particles and wind speed, on-line validation can be realized conveniently, and the reliability and verifiability of the system can be improved greatly.