Aging Aseptic and Biologic Manufacturing Sites: Design and Renovation for Compliance
Decades of mergers, acquisitions and business consolidations have resulted in a global shortage of aseptic fill sites and flexible biological manufacturing plants.
Only a limited number of facilities remain — in poor condition with generally weak infrastructures — producing and performing well beyond their anticipated useful life span.
And that's despite substantial new GMP regulations, general engineering practices and innovative design philosophies introduced by the FDA and international regulators.
Of course, if you are a drug sponsor or contract manufacturer, there are massive compliance risks awaiting you in these facilities.
Leading Expert Tells How to
In this new management report, you'll explore the modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years.
These upgrades can also make facilities more compliant, cut down on operating risks and improve performance.
Expert Herman Bozenhardt will tap into his 39 years of experience to show you 3 key areas you must address to properly redesign and renovate your aseptic and biologic facilities -- and reduce the risk of enforcement actions from the FDA and international regulators.
The 3 critical areas you must deal with are: 1) process core, 2) architecture, and 3) heating and ventilation and air conditioning (HVAC).
Best Practices to Employ and
In the report, you'll get the details you need to put best practices to use in these 3 areas, such as:
Drugmakers continue to take on significant risk today by manufacturing at out-of-date aseptic fill sites and biological manufacturing plants.
Let Herman Bozenhardt and Aging Aseptic and Biologic Manufacturing Sites: Design and Renovation for Compliance show you how to bring your facilities into compliance — with fewer risks and far better performance.
Order Your Copy Today!