For Convenient and Secure Sterile Disconnection of Flexible Tubing
The Kleenpak sterile disconnector provides an easy to use, secure method for the sterile disconnection of flexible tubing assemblies, even in an uncontrolled environment.It can also be used in processes involving single-use systems as well as hybrid systems.断开器可确保断开前后流程无菌。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.该装置可用于工艺的所有阶段，尤其对于上游及制剂和灌装应用特别有价值，在这些应用中，易用性和无菌保证至关重要。颇尔 Life Sciences can engineer and manufacture state-of-the-art Allegro™ single-use systems with Kleenpak sterile disconnectors for all these critical applications.
优势
 |
- 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 disposable system
材料成分
| Main body | 聚砜 |
| Male side plunger | 聚砜 |
| Female side connector | 聚砜 |
| Poppet valve | 聚砜 |
| O 型圈 | Silcone |
| Anti-actuation collar | Thermoplastic elastomer |
| Anti-disconnection collar | Thermoplastic elastomer |
| Female end cover | 聚砜 |
Aqueous Extractables (NVR)
|
Water at 60-65 °C after autoclaving at 130 °C and Gamma irradiation of 51.2 kGy |
Typically < 1 mg |
Sterilization Methods
| Gamma irradiation | Maximum 50 kGy |
| Autoclave | 75 minutes at 130 °C |
Consult with 颇尔 Corporation on sterilization methods
Operating Conditions
| Maximum operating pressure and temperature | 3 bar at 40 °C |
Liquid Flow Characteristics
Nominal Dimensions
| 描述 | 尺寸 | ||
| 6 mm (1/4 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
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 颇尔 (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!
第 1 步：Pull (remove) male side anti-actuation collar
第 2 步：Push male section into female sections 'CLICK'
第 3 步：Pull (remove) anti-disconnection collar
第 4 步：Twist to separate the two sections
应用
- 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 disposable system
| Part Number | 描述 | Packaging |
| KPD01FEC | Female End Cover | 10 per box, double bagged |
| KPD01HB7 | 6 mm (1⁄4 in.)Kleenpak sterile disconnector | 25 per box, double bagged |
| KPD01HB10 | 9.5 mm (3⁄8 in.)Kleenpak sterile disconnector | 25 per box, double bagged |
| KPD01HB6 | 13 mm (1⁄2 in.)Kleenpak Sterile Disconnector | 25 per box, double bagged |
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.
