Kleenpak™ Sterile Disconnectors

The disconnector consists of a joined male and female unit, to fit tubing with 13 mm (½ in.) ID. Kleenpak sterile disconnectors can either be autoclaved up to 130 °C or gamma irradiated up to 50 kGy.

 

The Kleenpak sterile disconnector brings a major improvement to single-use technology in aseptic processing. It can be used at all stages of the process, but will be particularly valuable in upstream and formulation & filling, where both ease of use and sterility assurance are critical. Pall can engineer and manufacture state-of-the-art Allegro™ single-use systems with Kleenpak sterile disconnectors for all these critical applications.

 

Benefits

• Disconnection can be performed in non controlled environment without compromising the sterility of fluid path 
• No capital equipment required
• Disconnection is performed in seconds
• Easy to make disconnection – even in cramped environments
• Microbial control or sterilization by autoclave or gamma irradiation 
• Activation enables a sterile separation. 
• Locking mechanism prevents incorrect disassembly
• Secure permanent disconnection security – cannot be reconnected
• No flow restrictions as a result of using of the Kleenpak sterile disconnector

 

Warning: This product is not sold sterile. For use in making sterile disconnections, each disconnector must be fitted to a closed single-use assembly that has been subjected to a validated sterilizing process.

• Disconnection after transfer of inocula to fermentors or bioreactors
• Disconnection after sampling
• Disconnection of small sterile equipment from large equipment (e.g. bioreactors)
• Disconnection while handling bulk material in a non sterile environment
• Disconnection from tank to filling line
• Disconnection from a single-use system

Materials of Construction

Component	Material of Construction
Main body	Polysulfone
Male side plunger	Polysulfone
Female side connector	Polysulfone
Poppet valve	Polysulfone
O-rings	Silcone
Anti-actuation collar	Thermoplastic elastomer
Anti-disconnection collar	Thermoplastic elastomer
Female end cover	Polysulfone

 

Aqueous Extractables (NVR)

Aqueous Extractables	Value
Water at 60-65 °C after autoclaving at 130 °C and Gamma irradiation of 51.2 kGy	Typically < 1 mg

 

Sterilization Methods

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

 

For additional information about sterilization methods, please contact Pall.

 

Operating Conditions

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

 

Liquid Flow Characteristics

 

 

 

Nominal Dimensions

 

Description	Dimensions
	6 mm (¼ in.)	9 mm (3⁄8 in.)	13 mm (1⁄2 in.)
Total length (A)	156 mm (6.1 in.)	156 mm (6.1 in.)	121 mm (4.8 in.)
Maximum diameter (B)	61 mm (2.4 in.)	61 mm (2.4 in.)	61 mm (2.4 in.)
Internal diameter (C)	6.35 mm (0.25 in.)	9.5 mm (0.38 in.)	13 mm (0.5 in.)
Maximum diameter male side (D)	61 mm (2.4 in.)	61 mm (2.4 in.)	61 mm (2.4 in.)
Maximum length male side once disconnected (E)	102 mm (4.0 in.)	102 mm (4.0 in.)	85 mm (3.3 in.)
Maximum length female sidewith female end cover once disconnected (F)	52 mm (2.0 in.)	52 mm (2.0 in.)	36 mm (1.4 in.)
Maximum diameter of female side with female end cover (G)	36 mm (1.4 in.)	36 mm (1.4 in.)	36 mm (1.4 in.)

 

Schematic Drawings¹

 

Full Assembly

 

Male Side - Disconnected

 

Female Side with Cap - Disconnected

 

¹For illustrative purposes, drawings show 13 mm (1⁄2 in.) hose barb connections

 

Quality Standards

 

• Manufactured under clean conditions in a controlled environment
• Manufactured under a Quality Management System certified to ISO9001
• Supplied with a Certificate of Test confirming the quality standards and quality control tests performed by Pall (including USP <85> and particulate tests)
• Validation tests include:
  • Mechanical tests
    • Leak; Burst; Creep rupture and pressure hold test
  • Resistance to freezing storage
  • Functional tests
    • Water flow characteristics
    • Bacterial spore challenge ("soiling") test
    • Autoclave and gamma resistance
  • Shelf life studies
  • Extractables
    • Absence of BPA (Bisphenol-A) and pthalates
• The fluid path materials of construction have been tested and meet the requirements of:
  • USP Class VI 121 ºC - Biological reactivity in vivo
  • USP 87 - Biological reactivity in vitro
  • USP 661 - Physicochemical tests
• The fluid path materials of construction do not contain any substances derived from animal products (i.e. TSE/BSE risk free)

 

Sterile Disconnections in Less Than 30 Seconds!

 

Step 1: Pull (remove) male side anti-actuation collar

Step 2: Push male section into female sections 'CLICK'

Step 3: Pull (remove) anti-disconnection collar

Step 4: Twist to separate the two sections