Restricted access barrier system RABS technology for sterile dosage form manufacturing and filling.
Sterile dosage form is required to maintain its sterility and it directly depends on the movement of personnel working in the aseptic filling area. Slightest movement of personnel can shed a huge number of particles in the filling area and there will be a risk of contamination of product being filled.
Machines are made up of SS 316 and once cleaned and sterilized can maintain the sterile environment unless it is disturbed by manual interventions.
Manual interventions and man movement is required to control very critically to maintain the sterility of product being filled in an aseptic filling area.
One method to achieve the enclosed aseptic environment with limited handling is use of isolators, isolators isolate the critical activity inside a contained environment, isolators are provided with heap filters which are capable of maintaining sterile environments and controlled particle count in critical areas.
But one disadvantage is that it cannot withstand a bigger area and for longer duration, it is required to be cleaned and disinfected frequently.
Therefore, Restricted access barrier system technology is one that takes care of above concerns, once cleaned and decontaminated, sterilized it can maintain a class 100 and sterile environment for longer duration.
The walls of the RABS are rigid and hermetically sealed with the filling area which actually separates the aseptic filling area from the outer area with a physical barrier.
The RABs are provided with UV light and Gloves at intermittent location to facilitate handling of product, adjusting weights during filling and setting parameters on the filling machine. Additional ports for media plates for environment monitoring inside the aseptic area during filling activity or during routine monitoring are provided, glove integrity testers are also provided so that before start of the aseptic filling activity it can be assured that there is no leakage in the gloves.
Restricted access barrier system RABS are very useful in sterile dosage form manufacturing and filling, with the help of RABS actually the risk of product getting contaminated due to manual manipulations can be eliminated completely.
Design of Restricted access barrier system (RABS) include following aspects.
1)Rigid wall enclosed, with finished surface to prevent accumulation of particles, and can be cleaned and decontaminated easily.
2)Unidirectional flow units with HEPA filtered provide filtration of air inside the critical area and help maintain the clean air class required for sterile dosage form.
3)Facility to do sterilization in place of machine parts that come in contact with the product, its primary containers and closures.
4) Facility to do sterilization of parts which cannot be sterilized in place, but can be autoclaved and transferred inside the RABS without compromising the sterility of the area and aseptically assembled again.
5) Facility to do aseptic manipulations during filling.
6) Facility to introduce inside RABS the media plates and indicators, air samplers and place them inside the RABS, without compromising the sterility of the environment inside the RABS.
There are two types of RABS based on the additional UDAF facility and partial and complete separation from the outer area with barrier walls.
1)Passive RABS utilizes the room’s air filtration system. When the outer environment is completely separated by walls it is called as passive closed RABS.
2) Active RABS is provided with additional UDAF inside the RABS. . When the outer environment is completely separated by walls it is called Passive closed RABS.
Gloves and gauntlets are sterilized and fitted aseptically without compromising the sterility of the environment.
It is required for a RABS system to have in place a sterilization procedure for all non-contact parts with a highly effective sterilizing agent which includes sporicidal.
Validation of Restricted access barrier:
Validation of Restricted access barrier RABS is done by doing the following activity.
Risk evaluation should be done for RABS and a risk based approach is required for performing the validation of RABS, following points are considered during the validation of Restricted access barrier system.
1) Particle count inside the RABS. Air velocity test, HEPA filter leak test, flow pattern.
2) Pressure differential to maintain and establish documentary evidence. Pressure inside the RABS should be greater than the outer area.
3) Inner surface of RABS to monitor for microbial load, with swab test.
4) Media fill to be done for consecutive events, to establish the environment and the procedure adapted for sterilization of contact parts are adequate.