Kleenpak™ Sterile Connectors

The disposable Kleenpak sterile connector allows for the dry connection of two separate fluid pathways, while maintaining the sterile integrity of both. 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
Kleenpak Sterile Connectors

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Description

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 

 

Further information is available in the product validation guide. Please contact Pall.

 

Further Information

 

Products in this datasheet may be covered by one or more patents including :

EP 0 981 389

EP 1 297 861

US 6,655,655

US 6,880,801

US 7,090,191

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

Documents

Datasheets

  • Kleenpak™ Sterile Connector

    Select Language :
    English

Specifications

 Materials of Construction

 
Component Material of Construction
Connector body ¹ Polycarbonate
Plunger Polycarbonate
Rubber grommets Thermoplastic elastomer
Adapters Polycarbonate with TiO2
O ring Internally lubricated ethylene propylene
Protective cap Polypropylene
Peel-away strip Hydrophobic polyethersulfone
Anti-actuation ring Thermoplastic elastomer

1 Fluid path


Aqueous Extractables (NVR)

 
Aqueous Extractables Value
Water at 20 – 25 °C after autoclaving at 130 °C Typically < 1 mg

 

Sterilization Methods

 

Please contact Pall for best practices on sterilization methods.

 

Sterilization Method Guidance
Gamma irradiation 50 kGy
Autoclave 75 minutes at 130 °C

 

Operating Conditions

 
Parameter Value
Maximum operating pressure and temperature 3 bar at 40 °C

 

Connections (Male and Female)

 
Sizes
6 mm (¼ in.) hose barb
9.6 mm (⅜ in.) hose barb
13 mm (½ in.) hose barb
15.8 mm (⅝ in.) hose barb

 

Nominal Dimensions

 

  6 mm (¼ in.)
Hose Barb		 9.6 mm (⅜ in.)
Hose Barb

13 mm (½ in.) 

Hose Barb

 15.8 mm (⅝ in.)
Hose barb
Male KPCHT02M7 KPCHT02M10 KPCHT02M6 KPCHT02M11
Female KPCHT02F7 KPCHT02F10 KPCHT02F6 KPCHT02F11
Internal diameter 5.5 mm (0.22 in.) 8.2 mm (0.32 in.) 12.2 mm (0.48 in.) 13.8 mm (0.54 in.)
Length when actuated 173 mm (6.8 in.) 173 mm (6.8 in.) 123 mm (4.8 in.) 173 mm (6.8 in.)
Female connector length with cap 80 mm (3.2 in.) 80 mm (3.2 in.) 55 mm (2.17 in.) 83 mm (3.27 in.)
Maximum diameter of female connector 38 mm (1.48 in.) 38 mm (1.48 in.) 38 mm (1.48 in.) 38 mm (1.48 in.)
Male connector length with cap 125 mm (4.92 in.) 125 mm (4.92 in.) 100 mm (3.94 in.) 128 mm (5.04 in.)
Maximum diameter of male connector 38 mm (1.48 in.) 38 mm (1.48 in.) 38 mm (1.48 in.) 38 mm (1.48 in.)

 

Specifications and availability: The information provided is a guide to the part number structure and possible options. Product availability may be subject to change without notice. All specifications are nominal.
 
Warning: This product is not sold sterile. For use in making sterile connections, each connector must be fitted to a closed single-use assembly that has been subjected to a validated sterilizing process.

Additional Information