优势
-
No capital equipment required
- Connection is made in seconds
- Connector can be autoclaved or Gamma sterilized
- Easy to make connection – even in cramped environment
- Maintains a sterile fluid pathway upon activation of device
- Peel-away strip maintains sterility until ready to use
- Vented to allow steam penetration and to prevent tubing collapse after autoclaving
- Shape coding ensures proper alignment
- Locking mechanism prevents incorrect assembly
- Device makes audible click when engaged
- Permanent connection for security – cannot be re-opened
Quality Standards
- Manufactured under clean 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 颇尔 (including endotoxin USP<85> and particulate tests)
Validation tests include:
- Burst
- Creep-rupture
- Tensile strength
- Aerosol challenge
- Shelf-life
- Absence of BPA (Bisphenol-A)
- Bacterial spore challenge ('soiling') test
- Closure integrity
- Water flow characteristics
- Extractables
- Autoclave
The fluid path materials of construction meet:
- Biological Reactivity Tests in vivo for Class VI-121°C Plastics, USP <88>
- USP Physicochemical Tests for plastics, USP<661>
连接器验证
颇尔 offers a comprehensive connector validation service to ensure a smooth product implementation without delay.Validation packages will be tailored to meet your specific needs and will include some or all of the following:- 兼容性评估
- 溶出物分析
- 污染测试
Further information is available at Connector Validation.
更多信息
Further information is available at BioPharmaceutical Single Use System Components
Products in this datasheet may be covered by one or more patents including :
EP 0 981 389
EP 1 297 861
US 6,655,655
US 6,880,801
US 7,090,191
应用
- Transfer of inoculums to reactors
- Sampling during fermentation or cell culture
- Connection of small sterile equipment to large equipment (e.g. bioreactors)
- Handling of bulk material in a nonsterile environment
- Connection from tank to filling line
- Connection to a disposable system
- Sensor insertion into bioreactor
材料成分
| Connector body 1 | 聚碳酸酯 |
| Plunger |
聚碳酸酯 |
| Rubber grommets | Thermoplastic elastomer |
| Adapters | Polycarbonate with TiO2 |
| O ring | Internally lubricated ethylene propylene |
| Protective cap | 聚丙烯 |
| Peel-away strip | Hydrophobic polyethersulfone |
| Anti-actuation ring | Thermoplastic elastomer |
1 Fluid path
Aqueous Extractables (NVR)
| Water at 20 – 25 °C after autoclaving at 130 °C | Typically < 1 mg |
Sterilization Methods
Consult with 颇尔 Corporation on sterilization methods
| Gamma irradiation | 50 kGy |
| Autoclave | 75 minutes at 130 °C |
Operating Conditions
| Maximum operating pressure and temperature | 3 bar at 40 °C |
Connections (Male and Female)
| 6 mm (¼ in.) hose barb |
| 9.6 mm (3/8 in.) hose barb |
| 13 mm (½ in.) hose barb |
| 15.8 mm (5/8 in.) hose barb |
Nominal Dimensions
| 6 mm (¼ in.)Hose barb | 9.6 mm (3/8 in.)Hose Barb | 13 mm (½ in.)Hose Barb | 15.8 mm (5/8 in.)Hose barb | |
|
Male Female |
KPCHT02M7 KPCHT02F7 |
KPCHT02M10 |
KPCHT02M6 |
KPCHT02M11 KPCHT02F11 |
| Internal diameter | 5.5 mm (0.22 in.) | 8.2 mm (0.32 in.) | 12.2 mm (0.48 in.) | 13.8 mm (0.54 in.) |
| Length when actuated | 173 mm (6.8 in.) | 173 mm (6.8 in.) | 123 mm (4.8 in.) | 173 mm (6.8 in.) |
| Female connector length with cap | 80 mm (3.2 in.) | 80 mm (3.2 in.) | 55 mm (2.17 in.) | 83 mm (3.27 in.) |
| Maximum diameter of female connector | 38 mm (1.48 in.) | 38 mm (1.48 in.) | 38 mm (1.48 in.) | 38 mm (1.48 in.) |
| Male connector length with cap | 125 mm (4.92 in.) | 125 mm (4.92 in.) | 100 mm (3.94 in.) | 128 mm (5.04 in.) |
| Maximum diameter of male connector | 38 mm (1.48 in.) | 38 mm (1.48 in.) | 38 mm (1.48 in.) | 38 mm (1.48 in.) |
| Part Number | 描述 | Quantity |
| KPCHT02F6 | Female connector with 13 mm (½ in.) hose barb | 25 per box, double bagged |
| KPCHT02M6 | Male connector with 13 mm (½ in.) hose barb | 25 per box, double bagged |
| KPCHT02F7 | Female connector with 6 mm (¼ in.) hose barb | 25 per box, double bagged |
| KPCHT02M7 | Male connector with 6 mm (¼ in.) hose barb | 25 per box, double bagged |
| KPCHT02F10 | Female connector with 9.6 mm (⅜ in.) hose barb | 25 per box, double bagged |
| KPCHT02M10 | Male connector with 9.6 mm (⅜ in.) hose barb | 25 per box, double bagged |
| KPCHT02F11 | Female connector with 15.8mm (5/8 in.) hose barb | 25 per box, double bagged |
| KPCHT02M11 | Male connector with 15.8mm (5/8 in.) hose barb | 25 per box, double bagged |
| KPC01A | Assembly Aid | 1 per box |
