Kleenpak™ II Sterile Connectors

The Kleenpak II sterile connector has been designed to allow for the connection of large processing equipment in order to obtain fast, safe and reliable sterile transfer of large volumes. With this sterile connector, large single-use systems ( > 100 L), such as the Allegro™ systems, will be operated at much faster speeds. There will be minimal fluid restriction in the tubing lines.

 

Different connector options are available to allow for the connection of 19 mm (¾ in.) and 25.4 mm (1 in.) ID nominal tubing including a 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange compatible fitting for maximum operational flexibility. Kleenpak II sterile connectors can be either gamma irradiated to a maximum of 50 kGy or autoclaved up to 130°C to suit different processing requirements.

 

Features and Benefits

• Fast and easy to make sterile connection (4 simple steps) – even in cramped and uncontrolled environments
• No capital equipment required
• Permanent connection for security – cannot be disconnected
• Available with either 19 mm (¾ in.) and 25.4 mm (1 in.) hose barb fittings or compatible 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange
• Allows for the connection of different sizes tubing and material
• Can be autoclaved or gamma sterilized
• Device makes audible click when properly engaged
• Clear actuation and locking mechanism prevents incorrect assembly
• Minimal flow restrictions
• Caustic resistant - Sodium hydroxide (caustic soda) and sodium hypochlorite (bleach) testing performed

 

Figure 1

4 easy steps...

 

 

Quality Standards

• Manufactured under cleanroom 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 leak testing, endotoxin USP <85> and particulate testing)
• 100% leak tested during manufacture
• The fluid path materials of construction have been tested and meet the regulatory requirements of:
  • USP 85 - Endotoxin
  • USP 88 - Biological reactivity in vivo for Class VI 121°C plastics
  • USP 87 - Biological reactivity in vitro
  • USP 661 - Physicochemical tests
  • USP 788 - Particulate test
• The fluid path materials of construction do not contain substances derived from animal products (i.e. BSE/TSE risk free)

• Connection to perform inocula transfer to reactors
• Connection to/from large biocontainers or tanks
• Connection to equipment (e.g., bioreactors)
• Connection to perform handling of bulk material in an uncontrolled environment
• Connection to bioreactor harvest equipment
• Connection to a disposable system
• Connection to perform probe insertion into biocontainer
• Connection to TFF equipment for ultrafiltration

Validation Tests

• Mechanical tests
  • Leak (closure integrity); Burst; Creep rupture and pressure hold test; Tensile strength
• Functional tests
  • Extreme temperature pressure leak test strength and performance testing
  • Water flow characteristics
  • Bacterial spore challenge (“soiling”) test
  • Autoclave and gamma resistance
• Shelf life studies
• Extractables - Water and Ethanol results available on request
  • Absence of BPA (Bisphenol-A) and phthalates

Please refer to product validation guide (USTR 2820) for further details of the validation tests performed.

 

Materials of Construction

Product Contact Parts	Material of Construction
Connector body / plunger	Polysulfone
O-ring	Silicone

Product Non-Contact Parts	Material of Construction
Protective cap	Polypropylene
Rubber seals	Thermoplastic elastomer
Peel-away strip	Aluminum foil with polyester coating

 

Extractables (NVR)⁽¹⁾

 

Aqueous Extractables	Value
Water at 60 – 65 °C after gamma irradiation at 50 kGy and autoclaving at 130 °C	Typically < 1 mg
Ethanol at 20 – 25 °C after gamma irradiation at 50 kGy and autoclaving at 130 °C	Typically < 5 mg

¹ Performed on 2 pairs of connectors in series

Sterilization Methods

Sterilization Method	Guidance
Gamma irradiation	Maximum 50 kGy
Autoclave	One 75 minute cycle at 130 °C

 

Dimensions

	19 mm (¾ in.) Hose Barb	25.4 mm (1 in.) Hose Barb	25.4 - 38.1 mm (1 - 1½ in.) Sanitary Flange
Male	KPC03M5	KPC03M9	KPC03M1
Female	KPC03F5	KPC03F9	KPC03F1
Internal diameter (A)	17.3 mm (0.68 in.)	24.2 mm (0.95 in.)	32.15 mm (1.27 in.)
Length when actuated (B)	162 mm (6.38 in.)	162 mm (6.38 in.)	138 mm (5.43 in.)
Female connector length with cap (C)	79.15 mm (3.1 in.)	79.15 mm (3.1 in.)	67.15 mm (2.64 in.)
Maximum diameter of female connector with cap (D)	60 mm (2.36 in.)	60 mm (2.36 in.)	60 mm (2.36 in.)
Male connector length length with cap (E)	101.5 mm (4 in.)	101.5 mm (4 in.)	89.5 mm (3.52 in.)
Maximum diameter of male connector with cap (F)	66 mm (2.6 in.)	66 mm (2.6 in.)	66 mm (2.6 in.)

Figure 2

Dimensions

 

Operating Conditions⁽²⁾

Parameter	Value
Operating pressure and temperature range	Up to 4 bar at 2 - 40 °C short-term use Up to 3 bar at 2 - 40 °C long-term use

Long term: 2° C and 40° C at 3 barg (43.5 psig) for 30 days

Short term: 2° C and 40° C at 4 barg (58 psig) for 2 days

 

Figure 3

Kleenpak II Sterile Connector Flow/Differential Pressure