Description
The disconnectors can also be used in processes involving single-use systems as well as hybrid systems. The disconnector maintains sterility of the fluid path before and after disconnection. The disconnector consists of a joined male and female unit, to fit tubing with 6 mm (1⁄4 in.), 9.5 mm (3⁄8 in.) or 13 mm (1⁄2 in.) ID. Kleenpak™ sterile disconnectors can either be autoclaved up to 130 °C or gamma irradiated up to 50 kGy. The Kleenpak™ sterile disconnector can be used at all stages of the process, but will be particularly valuable in upstream and formulation & filling, where both ease of use and sterility assurance are critical. Benefits Disconnection can be performed in non controlled environment without compromising the sterility of fluid path No capital equipment required Disconnection is performed in seconds Easy to make disconnection – even in cramped environments Microbial control or sterilization by autoclave or gamma irradiation Activation enables a sterile separation. Locking mechanism prevents incorrect disassembly Secure permanent disconnection security – cannot be reconnected No flow restrictions as a result of using of the Kleenpak sterile disconnector Warning: This product is not sold sterile. For use in making sterile disconnections, each disconnector must be fitted to a closed single-use assembly that has been subjected to a validated sterilizing process. Applications Disconnection after transfer of inocula to fermentors or bioreactors Disconnection after sampling Disconnection of small sterile equipment from large equipment (e.g. bioreactors) Disconnection while handling bulk material in a non sterile environment Disconnection from tank to filling line Disconnection from a single-use system Performance Quality Standards Manufactured under clean conditions in a controlled environment Manufactured under a Quality Management System certified to ISO9001 Supplied with a Certificate of Test confirming the quality standards and quality control tests performed by Pall (including USP <85> and particulate tests) Validation tests include: Mechanical tests Leak; Burst; Creep rupture and pressure hold test Resistance to freezing storage Functional tests Water flow characteristics Bacterial spore challenge ("soiling") test Autoclave and gamma resistance Shelf life studies Extractables Absence of BPA (Bisphenol-A) and pthalates The fluid path materials of construction have been tested and meet the requirements of: USP Class VI 121°C - Biological reactivity in vivo USP 87 - Biological reactivity in vitro USP 661 - Physicochemical tests The fluid path materials of construction do not contain any substances derived from animal products (i.e. TSE/BSE risk free) Sterile Disconnections in Less Than 30 Seconds
