For convenient and secure sterile connection of flexible tubing in large volume operations
Kleenpak II sterile connectors allow for the dry connection of two separate fluid pathways, while maintaining the sterile integrity of both, even in an uncontrolled environment.The connector consists of a male and a female connector, each covered by an aluminum peel-away strip that protects the port and maintains the sterility of the sterile fluid pathway prior to connection.
The Kleenpak II sterile connector has been designed to allow for the connection of large processing equipment in order to obtain fast, safe and reliable sterile transfer of large volumes.With this sterile connector, large single-use systems ( > 100 L), such as the Allegro™ systems, will be operated at much faster speeds.There will be minimal fluid restriction in the tubing lines.
Different connector options are available to allow for the connection of 19 mm (¾ in.) and 25.4 mm (1 in.)ID nominal tubing including a 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange compatible fitting for maximum operational flexibility.Kleenpak II sterile connectors can be either gamma irradiated to a maximum of 50 kGy or autoclaved up to 130°C to suit different processing requirements.
特色及优点
- Fast and easy to make sterile connection (4 simple steps) – even in cramped and uncontrolled environments
- No capital equipment required
- Permanent connection for security – cannot be disconnected
- Available with either 19 mm (¾ in.) and 25.4 mm (1 in.) hose barb fittings or compatible 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange
- Allows for the connection of different sizes tubing and material
- Can be autoclaved or gamma sterilized
- Device makes audible click when properly engaged
- Clear actuation and locking mechanism prevents incorrect assembly
- Minimal flow restrictions
- Caustic resistant - Sodium hydroxide (caustic soda) and sodium hypochlorite (bleach) testing performed
图 1
4 easy steps...
Quality Standards
-
- Manufactured under cleanroom 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 leak testing, endotoxin USP ‹85> and particulate testing)
- 100% leak tested during manufacture
-
The fluid path materials of construction have been tested and meet the regulatory requirements of:
- USP 85 - Endotoxin
- USP 88 - Biological reactivity in vivo for Class VI 121°C plastics
- USP 87 - Biological reactivity in vitro
- USP 661 - Physicochemical tests
- USP 788 - Particulate test
- The fluid path materials of construction do not contain substances derived from animal products (i.e. BSE/TSE risk free)
- Connection to perform inocula transfer to reactors
- Connection to/from large biocontainers or tanks
- Connection to equipment (e.g. bioreactors)
- Connection to perform handling of bulk material in an uncontrolled environment
- Connection to bioreactor harvest equipment
- Connection to a disposable system
- Connection to perform probe insertion into biocontainer
- Connection to TFF equipment for ultrafiltration
Validation Tests
-
Mechanical tests
- Leak (closure integrity); Burst; Creep rupture and pressure hold test; Tensile strength
-
Functional tests
- Extreme temperature pressure leak test strength and performance testing
- Water flow characteristics
- Bacterial spore challenge (“soiling”) test
- Autoclave and gamma resistance
- Shelf life studies
-
Extractables - Water and Ethanol results available on request
- Absence of BPA (Bisphenol-A) and phthalates
Please refer to product validation guide (USTR 2820) for further details of the validation tests performed.
材料成分
| Product Contact Parts | |
| Connector body / plunger | 聚砜 |
| O-ring | Silicone |
| Product Non-contact Parts | |
| Protective cap | 聚丙烯 |
| Rubber Seals | Thermoplastic elastomer |
| Peel-away strip | Aluminum foil with polyester coating |
Extractables (NVR)(1)
|
Water at 60 – 65 °C after gamma irradiation at 50 kGy and autoclaving at 130 °C |
Typically ‹ 1 mg |
|
Ethanol at 20 – 25 °C after gamma irradiation at 50 kGy and autoclaving at 130 °C |
Typically ‹ 5 mg |
1 Performed on 2 pairs of connectors in series
Sterilization Methods
Please refer to Instructions for Use (USD 2892) for sterilization methods
| Gamma irradiation | Maximum 50 kGy |
| Autoclave | One 75 minute cycle at 130 °C |
Dimension
|
Male Female |
19 mm (¾ in.)Hose Barb | 25.4 mm (1 in.)Hose Barb | 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange |
|
KPC03M5 KPC03F5 |
KPC03M9 KPC03F9 |
KPC03M1 KPC03F1 |
|
| Internal diameter (A) |
17.3 mm (0.68 in.) |
24.2 mm (0.95 in.) |
32.15 mm (1.27 in.) |
| Length when actuated (B) |
162 mm (6.38 in.) |
162 mm (6.38 in.) |
138 mm (5.43 in.) |
| Female connector length with cap (C) |
79.15 mm (3.1 in.) |
79.15 mm (3.1 in.) |
67.15 mm (2.64 in.) |
| Maximum diameter of female connector with cap (D) |
60 mm (2.36 in.) |
60 mm (2.36 in.) |
60 mm (2.36 in.) |
| Male connector length length with cap (E) |
101.5 mm (4 in.) |
101.5 mm (4 in.) |
89.5 mm (3.52 in.) |
| Maximum diameter of male connector with cap (F) |
66 mm (2.6 in.) |
66 mm (2.6 in.) |
66 mm (2.6 in.) |
图 3
尺寸
Operating Conditions(2)
|
Operating pressure and 温度范围 |
Up to 4 bar at 2 - 40 °C short term use Up to 3 bar at 2 - 40 °C long term use |
||||
2 |
Testing performed at the following conditions:
|
图 2
Kleenpak II Sterile Connector Flow/Differential Pressure
| Part Number | 描述 | Quantity |
| KPC03F9 | Female connector with 25.4 mm (1 in.) hose barb | 10 per box, individually double bagged |
| KPC03M9 | Male connector with 25.4 mm (1 in.) hose barb | 10 per box, individually double bagged |
| KPC03F5 | Female connector with 19 mm (¾ in.) hose barb | 10 per box, individually double bagged |
| KPC03M5 | Male connector with 19 mm (¾ in.) hose barb | 10 per box, individually double bagged |
| KPC03M1 | Male connector with 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange | 10 per box, individually double bagged |
| KPC03F1 | Female connector with 25.4 - 38.1 mm (1 - 1½ in.) sanitary flange | 10 per box, individually double bagged |
