Description
The connector consists of a male and a female connector, each covered by a vented peel-away strip that protects the port and maintains the sterility of the sterile fluid pathway. Different connector options are available to allow for the connection of 15.8 mm (⅝ in.), 13 mm (½ in.), 9.6 mm (⅜ in.) or 6 mm (¼ in.) nominal tubing. Kleenpak sterile connectors can either be autoclaved up to 130°C or Gamma sterilized. Benefits No capital equipment required Connection is made in seconds Connector can be autoclaved or Gamma sterilized Easy to make connection – even in cramped environment Maintains a sterile fluid pathway upon activation of device Peel-away strip maintains sterility until ready to use Vented to allow steam penetration and to prevent tubing collapse after autoclaving Shape coding ensures proper alignment Locking mechanism prevents incorrect assembly Device makes audible click when engaged Permanent connection for security – cannot be re-opened Quality Standards Manufactured under clean conditions in a controlled environment Manufactured under a Quality Management System certified to ISO 9001 Supplied with a Certificate of Test confirming the quality standards and quality control tests performed by Pall (including endotoxin USP<85> and particulate tests) Validation tests include: Burst Creep-rupture Tensile strength Aerosol challenge Shelf-life Absence of BPA (Bisphenol-A) Bacterial spore challenge ('soiling') test Closure integrity Water flow characteristics Extractables Autoclave The fluid path materials of construction meet: Biological Reactivity Tests in vivo for Class VI-121°C Plastics, USP <88> USP Physicochemical Tests for plastics, USP<661> Connector Validation Pall offers a comprehensive connector validation service to ensure a smooth product implementation without delay. Validation packages will be tailored to meet your specific needs and will include some or all of the following: Compatibility assessment Extractables analysis Soiling test Applications Transfer of inoculums to reactors Sampling during fermentation or cell culture Connection of small sterile equipment to large equipment (e.g., bioreactors) Handling of bulk material in a nonsterile environment Connection from tank to filling line Connection to a disposable system Sensor insertion into bioreactor Connectors and Disconnectors
