In this case, the interesting biopharmaceutical fluid transfer hoses is studied. During biopharmaceutical both vaccines and oncology research there are special biopharmaceutical hoses and hose assemblies that has to be used in the process. The demands are always there, where injection drugs are concerned.
The Biopharma manufacturers often need validation proof for their hoses and assemblies. Traditional certificates of conformance including FDA, EP 3.1, USP, ISO 10093 are often not sufficient to meet the process. Thus, additional hose validation research can meet more demanding criteria like BSE/TSE, extractability, pyrogenicity. Interesting matter is that Biopharmacutcal companies quality control is way more strict than pharmaceutical regarding purity of the hoses.
The one of the best hose suppliers for Biopharma sector is Tubes International. The section is devoted to biopharmaceutical market. The most common hoses are Sanitech and C-Flex family which are developed to meet the customer needs. These hoses meet the necessary certifications to work well with autoimmune and oncology chemicals. Some of the hoses like Sanitech STHT-C is permanently laser marked with part number and lot code for total product traceability. Additionally, the hose is Ultra-pure and made of biopharmaceutical grade silicone with unsurpassed surface smoothness. The most common applications are sterile fill and transfers, drug delivery as well as media processing.
In some cases, the assemblies disposables must be delivered as gamma sterilized hoses and hose assemblies to be repacked in a hose clean room and ready to use.