Extractables and leachables study
Single-use systems have been used for the preparation, storage and transport of biopharmaceutical liquids, intermediates and final drug products. Contaminants, additives or degradants may leach out from single-use system components, creating a risk to the quality of cell culture media and, potentially, the final biopharmaceutical drug product. Therefore, an important part of safety studies associated with the manufacture and handling of biopharmaceutical products is that any such extractables and leachables be both identified and quantified.
Longer BioSilicone tubing
Longer BioSilicone tubing provides a value-based solution in a broad range of applications including biopharmaceuticals, diagnostics, and food, carrying FDA ,USP Class VI and NSF51 certification.
Furthermore, these tubings have undergone the full standardised extractables test, involving three extraction solvents (50% ethanol solution, pH3 acidic solution and pH10 alkaline solution), tested to three different exposure times (1 day, 7 days and 21 days) and involving several analytical techniques, was performed by a fully-accredited, independent test lab. Results showed that BioSilicone tubing meets the biocompatibility requirements.
Biopharmaceutical processes are among the most critical in the world. We made the commitment and investment for full testing to satisfy our customers ‘needs.