by mdimembrane | Nov 29, 2024 | Sterile Filtration
Final sterile filtration is the subject of intense regulatory attention in the pharmaceutical and biopharmaceutical industries. According to EU Annex 1 2022 PUPSIT of final sterilizing grade filter is one of the requirements, additionally almost all other regulatory...
by mdimembrane | Sep 11, 2024 | PUPSIT in Single Use Systems, Single Use Systems
Sterile drug products produced by aseptic processing involve filtration through sterilizing grade filters. It is critical for the drug manufacturer to ensure that the sterilizing filter is integral during the entire filtration process, resulting in a sterile...
by mdimembrane | Jul 5, 2024 | Quality by Design
We are witnessing an industry-wide shift in biopharmaceutical manufacturing processes from reusable stainless steel systems to single use disposable systems, due to the need for higher flexibility, faster turnaround time and lower documentation and energy costs. Since...
by mdimembrane | Mar 18, 2024 | Single Use Systems
Many biopharmaceutical drug substance/products, process intermediates and chemically defined media (for mammalian cell culture) are light sensitive. Exposure of light sensitive drugs to UV or visible light, may result in degradation of drug molecules that may impact...
by mdimembrane | Nov 22, 2023 | Single Use Systems
MDI AseptiWave pre-sterilized and disposable bioreactors are designed for efficient cell culture of all cell types including Mammalian cells, Plant cells, Insect cells, Microbial cells, Stem cells, etc. These are available gamma sterilized, in multiple sizes ranging...
