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    RABS

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    of 3

    “What You Call That A RABS” 7 (Real-Life) Aseptic Filling Blunders T... https://www.pharmaceuticalonline.com/doc/what-you-call-that-a-rabs-real...

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    1 de 3 12-02-2020 17:50
    “What You Call That A RABS” 7 (Real-Life) Aseptic Filling Blunders T... https://www.pharmaceuticalonline.com/doc/what-you-call-that-a-rabs-real...

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    By Herman F. Bozenhardt and Erich H. Bozenhardt

    Restricted-access barrier systems (RABS) have been a major part of pharmaceutical aseptic filling operations for many years. They were
    introduced around the year 2000, and by 2007 there were 75 installations in the business globally.1 Today, there may be several hundreds,
    most of which are in GMP-compliant facilities and serving the needs of the business. RABS were born out of the need to: 1) protect the
    operators from the products they were filling, 2) improve filling compliance, 3) provide better access to a wider variety of filling process
    equipment, and 4) bring legacy lines into better compliance. This last point is critical for CMOs because their batch sizes vary widely,
    necessitating frequent and rapid changeovers, as well as addressing the variations in vial sizes and filling setup parameters.

    There are many excellent and scholarly articles written about RABS and RABS vs. isolators; however, this is not a technical article. This
    article is based upon our travels over the last 10 years, looking at aseptic filling operations and seeing what was described to be “a RABS”
    by the various owners. These RABS are all dubious devices created by their owners, who are deluding themselves into believing they have
    a validated aseptic RABS. Some of these are actually amusing, and they illustrate what happens when “hands-on” engineering meets the
    needs of operations while the compliance department is asleep at the wheel.

    Basics Of RABS And Aseptic Filling

    Although most of our readers are keenly aware of the types of RABS out there, let us review the standard types of the enclosure systems
    that encapsulate the open vials from the tunnel exit through the capping process.

    Active RABS – This design has its own HVAC/AHU and maintains the EU class A environment and recommended downward
    velocity of .36 to .45 m/s independent of the room’s HVAC system (as well as temperature and relative humidity).
    Passive RABS – Similar to the active RABS, this unit’s enclosure sides extend up to the ceiling and interface with the terminal HEPA
    array to provide the airflow. This design is dependent on the suite’s HVAC.
    Open RABS - This unit typically is a retrofit of an existing non-barrier line in which the airflow exits the unit below the fill line and
    exhausts into the room. This cannot be used while filling any cyto/toxin/potent compound.
    Closed RABS - This unit encapsulates the air internally, HEPA filters it, and recirculates it back to the unit or an HVAC return. This
    recirculation of the RABS air provides containment for any potent compound being filled.

    The modern designs combine the characteristics of active RABS with those of closed RABS into a cohesive design. Any contemporary
    passive and open RABS are retrofits and need to be carefully designed. Below are examples of bad and good RABS designs.

    Bad RABS design: This design is open (exhausts to the room randomly) and active (has its own HVAC/AHU overhead) but has plastic curtains that do not restrict
    access and generate pa

    2 de 3 12-02-2020 17:50
    “What You Call That A RABS” 7 (Real-Life) Aseptic Filling Blunders T... https://www.pharmaceuticalonline.com/doc/what-you-call-that-a-rabs-real...

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