Description
With its intuitive operation, sterile connections can be to be carried out in a simple three-step operation, even in an unclassified environment, without compromising the sterility of the fluid paths. The Kleenpak ™ Presto sterile connector brings enhanced levels of quality assurance with 100% inspection at point of manufacture that allows device traceability, as each device has its own serial number. The manufacturing process of the connectors brings an enhanced level of quality assurance, with the use of an automatic vision system that ensures the absence of defects in the membrane and membrane welding. Available in a variety of sizes – 6.35 mm (¼ in.), 9.53 mm (⅜ in.), 12.7 mm (½ in.), 15.8 mm (⅝ in.), 19 mm (¾ in.) hose barb, and 12.7 mm (½ in.) sanitary connection – the Kleenpak Presto sterile connector can be used in upstream processing, downstream processing, and formulation and filling. Made from Bisphenol-A (BPA) free Polyethersulfone (PES) the Kleenpak Presto sterile connector is compatible with a wide range of process fluids and solvents. Applications Kleenpak Presto Sterile Connector Media preparation and transfer Buffer preparation and transfer Transfer of inoculum to bioreactor Sampling during fermentation / cell culture Bioreactor harvest Sterile fluid transfer between unit operations Bulk handling of sterile material in non-classified environments Probe insertion into bioreactors, mixers and 3D biocontainers Sterile filtration manifolds Hybrid stainless steel and single-use system connection Connection of bulk sterile material to filling machine Sterile waste removal from process streams Quality Standards Manufactured under a quality management system certified to ISO9001 Manufactured in a clean room Class 7 in operation Supplied with a certificate of test confirming the quality standards and quality control tests performed by Pall Each connector is individually marked with batch number and serial number Batch release criteria: USP 85 - Endotoxin USP 788 - Particulate test Device release criteria: 100% inspection through vision system for absence of membrane and weld defects. The fluid path materials of construction have been tested and meet the regulatory requirements of: USP 88 - Biological reactivity in vivo for Class VI 121°C plastics USP 87 - Biological reactivity in vitro USP 661 - Physicochemical tests The fluid path materials of construction do not contain substances derived from animal products (i.e. BSE/TSE risk free) Validation Tests Mechanical tests Leak (closure integrity); burst; creep rupture and pressure hold test; tensile strength Functional tests Extreme temperature pressure leak test strength and performance testing Water flow characteristics Bacterial challenge (“soiling”) test using Brevundimonas diminuta Autoclave and gamma resistance Shelf life studies Extractables testing
