Kleenpak™ II Sterile Connector

For convenient and secure sterile connection of flexible tubing in large volume operations

Kleenpak II sterile connectors allow for the dry connection of two separate fluid pathways, while maintaining the sterile integrity of both, even in an uncontrolled environment. The connector consists of a male and a female connector, each covered by an aluminum peel-away strip that protects the port and maintains the sterility of the sterile fluid pathway prior to connection.

The Kleenpak II sterile connector has been designed to allow for the connection of large processing equipment in order to obtain fast, safe and reliable sterile transfer of large volumes. With this sterile connector, large single-use systems ( > 100 L), such as the Allegro™ systems, will be operated at much faster speeds. There will be minimal fluid restriction in the tubing lines.

Different connector options are available to allow for the connection of 19 mm (¾ in.) and 25.4 mm (1 in.) ID nominal tubing including a 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange compatible fitting for maximum operational flexibility. Kleenpak II sterile connectors can be either gamma irradiated to a maximum of 50 kGy or autoclaved up to 130°C to suit different processing requirements.

Features and Benefits

  • Fast and easy to make sterile connection (4 simple steps) – even in cramped and uncontrolled environments
  • No capital equipment required
  • Permanent connection for security – cannot be disconnected
  • Available with either 19 mm (¾ in.) and 25.4 mm (1 in.) hose barb fittings or compatible 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange
  • Allows for the connection of different sizes tubing and material
  • Can be autoclaved or gamma sterilized
  • Device makes audible click when properly engaged
  • Clear actuation and locking mechanism prevents incorrect assembly
  • Minimal flow restrictions
  • Caustic resistant - Sodium hydroxide (caustic soda) and sodium hypochlorite (bleach) testing performed

Figure 1
4 easy steps...


fig1

Quality Standards

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  • Manufactured under cleanroom 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 leak testing, endotoxin USP ‹85> and particulate testing)
  • 100% leak tested during manufacture
  • The fluid path materials of construction have been tested and meet the regulatory requirements of:
    • USP 85 - Endotoxin
    • USP 88 - Biological reactivity in vivo for Class VI 121°C plastics
    • USP 87 - Biological reactivity in vitro
    • USP 661 - Physicochemical tests
    • USP 788 - Particulate test
  • The fluid path materials of construction do not contain substances derived from animal products (i.e. BSE/TSE risk free)