Kleenpak Sterile Connector

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.

Features and 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
- 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>

Specification

Materials of Construction

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

Aqueous Extractables (NVR)

Aqueous Extractables (NVR)	Value
Water at 20 - 25°C after autoclaving at 130°C	Typically <1 mg

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 (1/4 in.) hose barb

9.6 mm (3/8 in.) hose barb

13 mm (1/2 in.) hose barb

15.8 mm (3/8 in.) hose barb

Nominal Dimensions

	6 mm (1/4 in) Hose Barb	9.6 (1/4 in) Hose Barb	13 mm (1/2 in) Hose Barb	15.8 mm (5/8 in) Hose Barb
Male	KPCH T02M7	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.)	13.8 mm (0.54 in.)
Female connector length with cap	80 mm (3.2 in.)	80 mm (3.2 in.)	55 mm (217 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 avaibility. The information provided is a guide to the part number structure and possible options. Product avaibility may be subject to change without notice. All specifications are nominal.

Warning: This product is not sold sterelie. For use in making sterelie connections. each connector must tbe fitted to a closed single-use assembly that has been subjected to a validated sterilizing process

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

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Point of Product

Features and Benefits

Quality Standards

Specification

Applications

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