Kleenpak™ Sterile Disconnectors
For Convenient And Secure Sterile Disconnection Of Flexible Tubing
Point of Product
Description
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.
Specification
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 |
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