Kleenpak™ Disconnectors product photo Primary L

Kleenpak™ Disconnectors

For Convenient and Secure Sterile Disconnection of Flexible Tubing

The Kleenpak sterile disconnector provides an easy to use, secure method for the sterile disconnection of flexible tubing assemblies, even in an uncontrolled environment. It 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 13 mm (½ in.) ID. Kleenpak sterile disconnectors can either be autoclaved up to 130 °C or gamma irradiated up to 50 kGy.

The Kleenpak sterile disconnector brings a major improvement to single-use technology in aseptic processing. It 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. Pall Life Sciences can engineer and manufacture state-of-the-art Allegro™ single-use systems with Kleenpak sterile disconnectors for all these critical applications.

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.



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Kleenpak sterile Disconnector

List Price
$ 18.12
List Price
$ 1,494.00
List Price
$ 1,494.00
List Price
$ 1,494.00
Description

For Convenient and Secure Sterile Disconnection of Flexible Tubing

The Kleenpak sterile disconnector provides an easy to use, secure method for the sterile disconnection of flexible tubing assemblies, even in an uncontrolled environment. It 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 13 mm (½ in.) ID. Kleenpak sterile disconnectors can either be autoclaved up to 130 °C or gamma irradiated up to 50 kGy.

The Kleenpak sterile disconnector brings a major improvement to single-use technology in aseptic processing. It 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. Pall Life Sciences can engineer and manufacture state-of-the-art Allegro™ single-use systems with Kleenpak sterile disconnectors for all these critical applications.

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 disposable system
Specifications

Materials of Construction

 
Main body Polysulfone
Male side plunger Polysulfone
Female side connector Polysulfone
Poppet valve Polysulfone
O-rings Silcone
Anti-actuation collar Thermoplastic elastomer
Anti-disconnection collar Thermoplastic elastomer
Female end cover Polysulfone
 

Aqueous Extractables (NVR)

 
Water at 60-65 °C after autoclaving at 130 °C
and Gamma irradiation of 51.2 kGy
Typically < 1 mg
 

Sterilization Methods

 
Gamma irradiation Maximum 50 kGy
Autoclave 75 minutes at 130 °C
 

Consult with Pall Corporation on sterilization methods

Operating Conditions

 
Maximum operating pressure and temperature   3 bar at 40 °C
 

Liquid Flow Characteristics

Nominal Dimensions

 
Description Dimensions
  6 mm (1/4 in.) 9 mm (3⁄8 in.) 13 mm
(1⁄2 in.)
Total length (A) 156 mm (6.1 in.) 156 mm (6.1 in.) 121 mm (4.8 in.)
Maximum diameter (B) 61 mm (2.4 in.) 61 mm (2.4 in.) 61 mm (2.4 in.)
Internal diameter (C) 6.35 mm (0.25 in.) 9.5 mm (0.38 in.) 13 mm (0.5 in.)
Maximum diameter male side (D) 61 mm (2.4 in.) 61 mm (2.4 in.) 61 mm (2.4 in.)
Maximum length male side once disconnected (E) 102 mm (4.0 in.) 102 mm (4.0 in.) 85 mm (3.3 in.)
Maximum length female sidewith female end cover once disconnected (F) 52 mm (2.0 in.) 52 mm (2.0 in.) 36 mm (1.4 in.)
Maximum diameter of female side with female end cover (G) 36 mm (1.4 in.) 36 mm (1.4 in.) 36 mm (1.4 in.)
 

Schematic Drawings1

Full Assembly

Kleenpak Sterile Disconnectors Full Assembly

 

Male Side - Disconnected
Kleenpak Sterile Disconnectors Male Side

Female Side with Cap - Disconnected
Kleenpak Sterile Disconnectors Female Side

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 ºC - 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!

Step 1: Pull (remove) male side anti-actuation collar

Step 2: Push male section into female sections 'CLICK'

Step 3: Pull (remove) anti-disconnection collar

Step 4: Twist to separate the two sections

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 disposable system
Application
Connectors and Disconnectors