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.
Applications
- 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
Documents
Datasheet
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Kleenpak™ Sterile Disconnector
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Specifications
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
Performance
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
- Mechanical tests
- 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
