Sterility Assurance Advances
Single Use Devices in Aseptic Manufacturing
Sterility assurance in aseptic manufacturing is one of the impressive technological advances over the last decade, ensuring the sterility and quality of a myriad of new drug and biological products and medical devices. These advances bring new treatments, improve quality of life and extend life expectancy for millions of patients. This paper summarizes some of those new sterility assurance technologies and focuses on a few examples that clearly enhance sterility assurance in the manufacturing of pharmaceuticals.
The pharmaceutical industry has been called upon to continually raise its sterility assurance standards through ongoing increased global regulatory standards, especially over the last ten years. Various regulatory agencies expect faster and more complete microbial contamination control.
In response to this expectation, suppliers have found a variety of approaches and solutions to meet these needs in a way that both satisfies regulatory requirements and helps pharmaceuticals save time and money by efficiently and accurately providing effective air and surface microbial monitoring. Top solutions for pharmaceutical contamination control meet at least one of the following criteria: sterility requirements, automation, and single use.