Single-use systems offer essential advantages – especially when standardized single-use sets are employed. They can be implemented quickly and affordably while reducing complexity.
Mixing equipment employed in the production of pharmaceuticals and medical devices deal with a higher level of complexity because their use is more specialized. Not one design fits all.
For the 50 or so years that cleanrooms have been in use, a steady debate has centered on the best ways to keep them clean, and regulatory and advisory agencies have weighed in on maintenance.
Cell and gene therapies are currently produced in fixed facilities that require a significant upfront investment. Modular concepts offer an opportunity to shift from these large, fixed assets.
A comparison of the EPA Trace Metal Analysis test was performed using duplicate sets of glassware. One set was acid washed by hand. The other was cleaned in the Miele Model PG8593 Flex Series Labwasher.
As the industry continues its move toward biologics, innovative solutions and technologies will be needed to ensure a safe and reliable approach to the manufacturing and delivery of these drugs.
The team at Polypeptide Labs' overall project aim was to achieve homogenization (blending/tumbling) of potent lyophilized polypeptide product offloaded from a separate isolator.