The Kleenpak Presto sterile connector is the next generation in the Allegro™ range of single-use fluid handling and management devices. This new genderless connection allows for the permanent sterile connection of two fluid streams for a large range of biopharmaceutical applications.
With its intuitive operation, sterile connections can be to be carried out in a simple 3 steps operation, even in an unclassified environment, without compromising the sterility of the fluid paths.
Key design features such as the anti-actuation tabs and tamper resistance protective cap give end users more confidence in operation and security of supply.
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 as its own serial number. The manufacturing process of Kleenpak Presto sterile 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.) 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.
Features and Benefits
Allows for the sterile connection of 2 fluid paths in an uncontrolled environment
Elimination of the need for laminar air flow hoods and glove boxes to carry out sterile connections
Reduction of part numbers and simplification of single-use systems
Presto seal technology
High pressure operation for up to 90 days
Operating temperature range 2 °C to 60 °C Storage to -80 °C Pressure rating from up to 3 barg for 90 days 4 barg for shorter periods
Can be used in a wide variety of applications - including tangential flow filtration (TFF) with pulsated 4 barg range
Operating pH range from 2 – 12 Compatible with Dimethylacetamide (DMA) and Dimethyl sulfoxide (DMSO)
Can be used in a wide range of processes, including antibody drug conjugates
6.35 mm (¼ in.), 9.53 mm (⅜ in.), 12.7mm (½ in.), 15.8 mm (⅝ in.) hose barb and 12.7 mm (½ in.) sanitary connections
Wide range of connection sizes allows handling of different volumes – universal face allows for step up and step down connections
Tamper resistant caps on devices
Enhance end user confidence between point of manufacturer and point of use
Error proof operation ensures that end user makes the sterile connection the correct way 100% of the time
Each size has a different colored cap
Clear visual indication for end user on sizes being used
BPA-free PES used as material of construction
Eliminates any BPA toxicological concerns
PES material compliant to USP 87, 88, 661, 85, 788
In line with regulatory expectations
Each device individually marked with batch number and serial number
Device traceability that is linked to the 100% on-line inspection at point of manufacture
Vision systems on 100% of devices during manufacturing
Vision system that is capable of detecting membrane and weld defects to ensure absence of critical defects