Join Jason Collins as he leads a Concurrent Session on Aseptic Facilities and Technologies as well as presents on Is your Facility on Borrowed Time? Part 1 at the ISPE Annual Meeting.
Focused on aseptic facilities and technologies, this session will take attendees through relevant and cutting-edge topics currently affecting the production of parenteral products. Attendees will dive into the challenges which are often found in aging facilities and learn about strategies for the justification and execution of modernization projects. They will also uncover recent learnings from the practical application of Single-Use Systems and find out whether this trend will continue as a viable option over stainless steel (or, is there another option…?) Finally, with the need for more vaccine and biological facilities, product safety and operator exposure are at the forefront of facility design requirements. This session will conclude with strategies for effective and repeatable Bio-decontamination cycles based on the analysis of available technologies.
In the opening plenary session at the 2021 ISPE Aseptic Conference, Rick Friedman addressed the continuum of legacy facilities stating: “Older facilities typically include processing lines and facility layouts that are less effective at mitigating the various operational variables that pose risk to product sterility.” There are countless aging sterile injectable facilities around the world that continue to operate on the edge of regulatory failure. They continue limping along for years, squeezing through audits based on extensive data reviews and the application of increased procedural controls. If you are responsible for, or work in such a facility and are looking for some tools and guidance to make facility or equipment improvements, this learning series is for you. This presentation will address how to identify the regulatory risks and potential consequences of not reinvesting and making facility or equipment improvements that meet today’s sterile injectable manufacturing standards. It will also cover the principles of putting together a business case to clearly communicate the justification for the facility or equipment upgrades. Lastly, this talk will also examine potential solutions and strategies for retrofitting a facility with minimal impact to ongoing operations.
Get more information and register here.