Kleenpak™ Sterile Connectors product photo Primary L

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 (5/8 in.), 13 mm (½ in.), 9.6 mm (3⁄8 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 

 

Further information is available at Connector Validation.

 

Further Information

Further information is available at BioPharmaceutical Single Use System Components

 

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


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Kleenpak sterile connectors, ¼ in (6 mm) hose barb connection, female, double-bagged, box of 25
List Price
$ 948.00
Kleenpak sterile connectors, ¼ in (6 mm) hose barb connection, male, double-bagged, box of 25
List Price
$ 948.00
Kleenpak sterile connectors, ⅜ in (9.6 mm) hose barb connection, female, double-bagged, box of 25
List Price
$ 948.00
Kleenpak sterile connectors, ⅜ in (9.6 mm) hose barb connection, male, double-bagged, box of 25
List Price
$ 948.00
Kleenpak sterile connectors, ½ in (13 mm) hose barb connection, female, double-bagged, box of 25
List Price
$ 948.00
Kleenpak sterile connectors, ½ in (13 mm) hose barb connection, male, double-bagged, box of 25
List Price
$ 948.00
Kleenpak sterile connectors, ⅝ in (15.8 mm) hose barb connection, female, double-bagged, box of 25
List Price
$ 976.00
Kleenpak sterile connectors, ⅝ in (15.8 mm) hose barb connection, male, double-bagged, box of 25
List Price
$ 976.00

Assembly Aid

Assembly aid for Kleenpak Sterile Connectors
List Price
$ 93.00
Description
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 (5/8 in.), 13 mm (½ in.), 9.6 mm (3⁄8 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 

 

Further information is available at Connector Validation.

 

Further Information

Further information is available at BioPharmaceutical Single Use System Components

 

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
 

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
Specifications
 

 Materials 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)

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

 

Sterilization Methods

Consult with Pall Corporation on sterilization methods

 
Gamma irradiation  50 kGy
 Autoclave  75 minutes at 130 °C
 

Operating Conditions

 
 Maximum operating pressure and temperature  3 bar at 40 °C
 

 

Connections (Male and Female)

 
  6 mm (¼ in.) hose barb
 9.6 mm (3/8 in.) hose barb
 13 mm (½ in.) hose barb
 15.8 mm (5/8 in.) hose barb
 

 

 

Nominal Dimensions

 
  6 mm (¼ in.) Hose barb 9.6 mm (3/8 in.) Hose Barb 13 mm (½ in.) Hose Barb 15.8 mm (5/8 in.) Hose barb
Male
Female 
KPCHT02M7
KPCHT02F7

KPCHT02M10
KPCHT02F10

KPCHT02M6
KPCHT02F6

KPCHT02M11
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.)
 

 

 

 

Application
Connectors and Disconnectors
Segment
Single-Use Solutions