Open RABS (oRABS) are useful to increase product protection, but they are not useful with toxic products, since they cannot offer any type of protection for the operator and the environment.

Advantages:

• Easy to install, also on existing machines
• Inexpensive
• Easy to validate (air flow, air classification, doors interlocks)
• Possibility to downgrade the production area to class B

Weaknesses:

• Surrounding production area must be class B (with an Isolator it can be downgraded to the less expensive class C)
• No operator protection, not useful with toxic products
• Humidity and temperature inside the O-RABS is dependent by the production room conditions
• There is no possibility to recycle the air used inside, saving HVAC energy consumption
• No possibility to perform WIP cycles (Wash In Place)
• No possibility to perform automatic decontamination cycles (for example with Vaporised Hydrogen Peroxide)

Closed RABS (cRABS) is a positive pressure system with onboard fan/filtration units to supply HEPA-filtered air over the critical process before being recirculated. All RABs can include glove ports, RTP systems, access doors with interlocks and EM systems.

Due to the lack of leak-tight certification, these systems can not be used for highly toxic products.

Also, these systems must assure a class A environment, and the surrounding must be classified as B.

Advantages:

• Easy to install, also on existing machines
• Easy to validate (air flow, air classification, doors interlocks)
• Possibility to downgrade the production area to class B
• Humidity and temperature inside the Closed-RABS can be controlled adopting a dedicated HVAC
• Possibility to recycle the air used inside, saving HVAC energy consumption

Weaknesses:

• Surrounding production area must be class B (with an Isolator it can be downgraded to the less expensive class C)
• Limited operator protection, not useful with highly toxic products
• No possibility to perform WIP cycles (Wash In Place)
• No possibility to perform automatic decontamination cycles (for example with Vaporized Hydrogen Peroxide)

RABS for pharmaceutical process and filling line

As described before the use of Isolation Technology allows the installation of a vial/syringe filling line for aseptic products in a production area classified as Class C, instead of a Class B that is requires when a Open RABS or a Closed RABS is used.

The downgrade of the classification of the production room allows the following Operation Cost savings:

• Less quantity of air required by the production room
• Less air sampling (particulate and microbiological)
• Less time spent by operators to enter/exit the classified room
• Less expensive gowning

Restricted Access Barrier Systems (RABS) are critical for maintaining aseptic conditions in pharmaceutical manufacturing environments, especially when handling sterile or cytotoxic drugs. By reducing human intervention, RABS minimize contamination risks during filling and other sensitive processes, ensuring high product quality and safety.

Key Components of RABS Systems:

1. Open RABS (oRABS):
   • Open Passive RABS: Utilizes the cleanroom’s existing overhead air supply system, delivering HEPA-filtered air over the critical process zone and returning it back into the cleanroom. This system provides an additional barrier but relies on external cleanroom airflow for filtration and protection.
   • Open Active RABS: Incorporates its own integrated ventilation system to deliver HEPA-filtered air to the critical process zone, further improving contamination control. Air is returned into the cleanroom but is actively filtered, enhancing the barrier’s effectiveness.
2. Closed RABS (cRABS):
   • A more advanced system that maintains a positive pressure environment around the critical process zone. It has an integrated ventilation system with HEPA-filtered air supplied over the critical process area. The air is then filtered through return filters before being recirculated.
   • Bio-decontamination Integration: Closed RABS can be enhanced with Vapour Phase Hydrogen Peroxide (VPHP) systems, which ensure the environment remains fully decontaminated, achieving CGMP class A or ISO 5 conditions. This makes the system ideal for handling sensitive or cytotoxic products that require a sterile environment at all stages of production.

Advantages of RABS Systems:

• Increased Aseptic Assurance: The reduced need for human intervention minimizes the risk of contamination, ensuring that drug manufacturing processes meet strict regulatory requirements.
• Flexible Integration: Tema Sinergie’s custom-designed RABS systems are fully integrated with the user’s specific needs, offering scalable solutions for different batch production sizes.
• Protection and Access: While providing a physical and aerodynamic barrier, RABS still allow for controlled access to the process zone when necessary, allowing operators to perform interventions in a sterile environment when required.

Additional Equipment:

• Preparation Isolators: For precise containment during the preparation stages of drug manufacturing.
• Unidirectional Airflow Carts: Ensures that airflow remains unidirectional, reducing cross-contamination risks.
• Bio-decon Pass-Through Chambers: Enables the safe transfer of materials into and out of the aseptic area without compromising the sterile environment.
• Sterility Testing Isolators: Specifically designed to perform sterility tests without the risk of contamination, critical for validating aseptic processes.

By integrating these systems into the production process, Shree Bhagwati provides a highly effective barrier solution for aseptic drug manufacturing, ensuring that sterile and cytotoxic products are handled in the most controlled environment possible.