DME Facility Focus 2: Restrictive Access Barriers: Best industry practices for retrofitting a legacy filling lines with a RABS barrier.

DME Facility Focus 2: Restrictive Access Barriers: Best industry practices for retrofitting a legacy filling lines with a RABS barrier.

04/18/2018, 1:00 PM - 2:00 PM

Technical Conference Stage 1, Booth 1076, Exhibit Hall

Language:
English

Many long-time manufacturers of sterile drug products will eventually wrestle with the "RABS versus Isolator" decision, which is, whether to build new isolator-based filling lines, or whether to retrofit legacy filling lines (based upon historical, conventional technology) with RABS barriers. Given the importance of regulatory compliance and product safety for older facilities, and no less, reliability of supply and cost effectiveness, the "RABS versus Isolator" decision can be crucial to ongoing success. And given the estimated 1000 to 2000 legacy sterile filling lines in the world, many utilizing outdated conventional aseptic technology, and many on "borrowed time" before regulatory and/or reliability challenges hit, evaluation of a RABS retrofit can be key. Therefore, the question becomes "What is the best path forward for the estimated 1000 to 2000 legacy filling lines in the world, and how can I evaluate retrofitting my existing legacy filling lines using RABS technology?" To answer this question and address these issues head on, DME has assembled a panel of industry experts to discuss the findings from our latest Facility Focus survey of pharma professionals. It's Time For Dialog – please join us for an eye-opening peek into the future possibilities of achieving long-term, robust compliance and product safety for legacy filling lines, by retrofitting legacy lines with compliant RABS.

Contributors

  • Hite Baker

    Speaker

    Principal Process Engineer

    DME

    An industry innovator in cGMP manufacturing, Hite’s focus is equipment and facility design for parenteral fill-finish operations. He has extensive...

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives What is a Restricted Access Barrier System (RABS)? • What is a RABS retrofit? When does retrofitting a legacy filling line make sense? • Do the FDA and EU like RABS? What is a "compliant" RABS? • How do I assess whether my legacy filling line is a candidate for a RABS retrofit? • What are the primary challenges for RABS retrofits? • What facility upgrades are typically recommended when doing a RABS retrofit? • Who are the leading equipment vendors to build a RABS retrofit enclosure? • FDA says I should NEVER open the door of my RABS during operation? True? How do I fix jambs if I am not allowed to open the doors? What happens if I must open a door to fix a jamb? • Gain a better understanding of the trends shaping our industry; what's driving change; how competitors are responding; and how others are turning problems into opportunities. • Enhance your understanding of the risks inherent in manufacturing modernization, and how to manage those risks most effectively.

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