Point of Product
Features and Benefits
| 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 |
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 Pall (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: o USP 85 - Endotoxin o USP 88 - Biological reactivity in vivo for Class VI 121°C plastics o USP 87 - Biological reactivity in vitro o USP 661 - Physicochemical tests o USP 788 - Particulate test |
| The fluid path materials of construction do not contain substances derived from animal products (i.e. BSE/TSE risk free) |
Specification
Materials of Construction
| Product Contract Parts | Material of Construction |
| Connector body/plunger | Polysulfone |
| O-ring | Silicone |
| Product Non-Contract Parts | Material of Construction |
| Protective cap | Polypropylene |
| Rubber seals | Thermoplastic elastomer |
| Peel-away strip | Alumunium foil with polyester coating |
Extractables (NVR)
Sterillization Methods
| Aqueous Extractables | Value |
| 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 |
| Sterilization Method | Guidance |
| Gamma irradiation | Maximum 50 kGy |
| Autoclave | One 75 minute cycle at 130°C |
Dimensions
| 19 mm (¾ in.) Hose Barb | 25.4 mm (1 in.) Hose Barb | 25.4 - 38.1 mm (1 - 1½ in.) Sanitary Flange | |
| Male | KPC03M5 | KPC03M9 | KPC03M1 |
| Female | KPC03F5 | KPC03F9 | KPC03F1 |
| Internal diameter (A) | 17.3 mm (0.68 in.) | 24.2 mm (0.95 in.) | 32.15 mm (1.27 in.) |
| Length when actualed (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 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.) |