(Restricted Access Barriers)

Open passive RABS utilise existing clean room overhead air supply systems to deliver HEPA-filtered air over the particle process before returning air back into the clean room. In an open active RABS onboard fan/filtration units supply HEPA-filtered air over the critical process before returning air back to the clean room. In open RABS, the enclosure is not sealed to the equipment.

Open RABS (oRABS)

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)

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)

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

The adoption of an Open or Closed RABS will allow reducing the AIR Handling costs by approx. 35%, compared with an installation in a conventional clean room.

Contact Brinda Pharma, Ahmedabad, India, today for all your RABS needs, including Open RABS (oRABS) and Closed RABS (cRABS). Our state-of-the-art barrier systems provide a safe and sterile manufacturing environment, ensuring product quality and safety. Trust us to provide you with an efficient and effective solution. Get in touch with us now!