The Filtration and Separation Blog
Barrier filters that simplify PUPSIT by supporting both liquid and air passage
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...
PUPSIT in Single Use Systems: Challenges and Risk Mitigation
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...
Quality by Design: Enhancing Biopharmaceutical Manufacturing
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...
AseptiBag™ ULO+ 2D Single Use Systems for Storage and Transfer of Light Sensitive Fluids
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...
AseptiWave Bioreactors for efficient cell growth
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...
AseptiProbe Bellow Assembly for Single Use Mixer and Bioreactor Systems
The growing trend towards incorporation of single use technologies into bioprocesses as an alternative to reusable systems have paved the way for many single use components and systems as these provide increased manufacturing flexibility. Bioprocess operations such as...
MDI Aseptimix MI: Single Use Mixer Systems
Mixing is a critical process requirement at multiple steps in Biomanufacturing. Various processes that involves mixing operation range from liquid-liquid mixing and solid-liquid mixing of different fluids such as media, growth regulators, harvests, post centrifuge...
Pre-loaded Customized Aseptic Sampling Systems vs Conventional Aseptic Sampling Systems
Aseptic closed single use sampling systems offer multiple advantages in terms of minimizing risk of: Process Contamination Loss of sample integrity and consistency Environmental contamination Operator safety in case of cytotoxic or other hazardous fluids In addition,...
Easier, Faster, and Ready to Use Solution for Aseptic Sampling: Preloaded Sampling Systems
MDI pre-loaded disposable sampling port cartridge with adapter does away with tedious, time-consuming assembly of ASESS sampling system ports in the cartridge and subsequently in the multiport adapters. This provides an easy, faster, ready-to-use sampling system which...
Customized Bottle Assemblies for high value, low volume drug products
Scientists at Biopharmaceutical R&Ds and process owners involved in the manufacture of high value products such as radiopharmaceuticals, are looking for ready to use customized, disposable mixing and transfer solutions that are easy to use and have a small...