Biopharmaceutical manufacturing involves multiple processes from cell culture in the upstream, cell harvest and protein purification in the downstream, and final fill and finish of the drug product. Each process step requires aseptic sampling, whether it is to monitor cell density, cell viability and metabolites in bioreactors, sterility and mycoplasma contamination in sterile media, bioburden, endotoxins and sterility in pre and post sterilizing filtration of the drug product. Many of these test applications require small and accurate volumes.
The ASESS® sampling systems with sampling syringe are designed for up to 5mL precision volume sampling for testing applications involving small volumes. This is specially useful when sampling high value process fluids, for example in manufacture of monoclonal antibodies and orphan drugs. These precision sampling syringes have a least count of 200µl with an accuracy of +5%.
The easy to use accurate volume, precision sampling syringes have been specially designed to ensure sterility of the drawn sample. The plunger moves within a specially designed bellow sealed in the barrel to ensure that there is no microbial ingress from the environment.
