There exists two key methods for controlling serious outbreaks of transmissible diseases: therapeutic countermeasures and transmission control through isolation and containment.
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. One option is to leverage the advanced aseptic manufacturing of blow-fill-seal (B/F/S) technology, which has the potential to address the challenges of traditional glass filling as well as the global distribution of biologics.
The team at Polypeptide Labs' overall project aim was to achieve homogenization (blending/tumbling) of potent lyophilized polypeptide product offloaded from a separate isolator.
Getting the best results from any cleaner requires proper mixing and cleaning procedures. This article includes mixing directions for aqueous cleaning detergent and methods for monitoring performance.
Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.
Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and cost reduced if the cleaner supplier can provide support.
Water is one of the most widely used raw materials in the pharmaceutical plant. Several grades of water are used throughout the plant. One grade, Water for Injection (WFI), is water purified by reverse osmosis or distillation as specified by the United States Pharmacopeia (USP). Specific tests for Conductivity apply to WFI Water produced on site for manufacturing purposes.