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

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

 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.)

 

 

 

Part Number	Description	Quantity
KPCHT02F6	Female connector with 13 mm (½ in.) hose barb	25 per box, double bagged
KPCHT02M6	Male connector with 13 mm (½  in.) hose barb	25 per box, double bagged
KPCHT02F7	Female connector with 6 mm (¼ in.) hose barb	25 per box, double bagged
KPCHT02M7	Male connector with 6 mm (¼ in.) hose barb	25 per box, double bagged
KPCHT02F10	Female connector with 9.6 mm (⅜ in.) hose barb	25 per box, double bagged
KPCHT02M10	Male connector with 9.6 mm (⅜ in.) hose barb	25 per box, double bagged
KPCHT02F11	Female connector with 15.8mm (5/8 in.) hose barb	25 per box, double bagged
KPCHT02M11	Male connector with 15.8mm (5/8 in.) hose barb	25 per box, double bagged
KPC01A	Assembly Aid	1 per box

For further information or advice, please email Allegro@pall.com