Aseptic isolation process
for filling and sealing of pre filled syringes

LT-TSB Automatic denesting machine for prefilled syringes (4)

Aseptic isolation process is a measure taken to reduce the risk of microbial contamination in the production of aseptic products. Personnel are the main source of contamination in the production process of aseptic products, so technical measures are needed to reduce the risk of personnel contamination.


Traditional aseptic processes mainly use PVC curtains and walls for isolation. Clean air is supplied and recirculated through an HVAC system, and a laminar flow is added around the A-grade area for protection. Product protection relies on limited pressure differentials. This process is suitable for aseptic production and manufacturing.

Subsequently, Restricted Access Barrier Systems (RABS) were developed, which provide more comprehensive isolation of the environment and personnel compared to traditional aseptic processes, and can be intervened and operated through gloves. RABS can be categorized as open (O-RABS) or closed (C-RABS), and can be further classified as active or passive based on the clean air supply method.


Passive O-RABS mainly use glass doors as the main means of isolation. Clean air is supplied and recirculated through HVAC, and it is connected to the environment. Operation is mainly carried out through RABS and doors, and material transfer is done through small doors or buffer airlocks. The RABS maintains limited positive pressure during operation and is suitable for aseptic production and manufacturing.