What is the difference between qualification and validation? This question comes up frequently with both internal and external clients.
With today’s complex manufacturing systems and processes, can a manufacturer afford to not have a centralized automation platform?
While there are “bad” fume hoods, anything wrong with the entire system (exhaust fan, ductwork, building configuration, regulative dampers) may cause a lack of containment in a hood.
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
Stability of your weighing balance is paramount when it comes to collecting reliable data for project. As the old adage goes, “Anything that can go wrong will go wrong.”. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success. The purpose of this paper is to inspire thought and dialogue regarding those “not so obvious” sources of balance stability issues. Below, you may find 10 prompt questions that will hopefully guide one in resolving those pesky head-scratchers.
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.
Single-use technology is well-established and made its way into commercial licensed facilities, but there is more innovation in this field which will enhance its versatility into new markets and technologies.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
The CleanFlow is a unidirectional, positive pressure, laminar air flow workstation.
Anton Paar’s process instrumentation ensures the continuous control of product quality and product specifications within tight tolerance limits.
TSI’s PresSura Room Pressure Products “The Standard” for low pressure room monitoring applications. Over 50,000 TSI systems are used every day to ensure safety in leading healthcare facilities.
AeroTrak Remote Particle Counters with Integrated Pump are ideal for use in any GMP-controlled area where continuous particulate and environmental monitoring is required. AeroTrak Remote Particle Counter Models 6310, 6510 and the vaporized hydrogen peroxide (VHP)-resistant 6510-VHP have the features needed for seamless integration.
Learn how to employ science-, risk-, and statistics-based approaches to cleaning and cleaning validation at your facility with this free, 100-page e-book, written by a global team of cleaning validation experts, pharmaceutical toxicologists, statisticians, and Six Sigma professionals.