Sterility Testing
Sterisart NF by Sartorius
Features
Sterisart NF by Sartorius
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General Description Microbiology International is pleased to announce the launch of Sterisart®NF (new family) for testing sterility of pharmaceutical products. These new sterility testing systems reduce filter manipulation and in turn eliminates the risk of secondary contamination and false positive results. Within the Sterisart® a full range of applications can be tested from closed sample containers, open containers such as ampoules or collapsible plastic bags, medical devices such as products packaged in syringes, and many more options. The international pharmacopoeias preferred method of sterility testing is using membrane filters as seen in the Sterisart® NF range. Any microorganisms present in a sample are concentrated on the unique Sartochem membrane filter surface in the sample containers, then nutrient media is added and the containers are incubated under the conditions specified. The Sterisart® NF units are easy to use with pre-installed tube clamps, clearly marked graduations, and product and lot number identification for easy traceability. 100% conformity to stringent international regulations (USP, EP, JP) is adhered to at all times. |
Sterisart Universal Pump
The new Sterisart® Universal Pump is a peristaltic pump made of stainless steel and is equiped with appropriate features for attaching a closed sterility test system and a sample container. The pump draws liquid from the sample container into the specially designed double tubing and distributes the liquid equally to both sample containers of the sterility test system. The sample is rinsed in a similar way. After the culture media is added, the sample containers are incubated for the predifined time under the conditions specified and evaluated.
The new Sterisart® Universal Pump can be used in clean rooms, intergrated into clean benches, or installed countersunk in the working surface of isolators. Its low, compact design has a space-saving footprint – a great benefit for clean room benchtops and isolators.
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The pump features: Increased Safety and Reliability Thanks to the use of a unique motor principle, the Sterisart Universal pump is designed with a completely closed pump chassis, eliminating the need for ventilation of the motor. As a result, the pump will not release any particles into clean room or isolator environments or cause turbulence in laminar-flow areas. This results in increased safety and reliability. |
Rugged and Maintenance-free
as the pump chassis is made of stainless steel, it features excellent chemical compatibility with sterilants used in isolators. This together with the unique type of motor, makes the pump highly rugged and virtually maintanence-free. |
| Compact and User-friendly
As space is limited in isolators and clean benches, the Sterisart Universal pump has been designed with a compact footprint and a low profile. It saves space and ensures excellent ergonomic handling, particularly in the areas in front of and above the pump. It is easy to access for cleaning and disinfecting the pump head. |
Modular Design
The new Sterisart Universal pump is designed with the idea in mind that the economical basic model can be upgraded later with an external control unit that has a built-in display. The pump can also be integrated into clean work benches as well as installed countersunk into the work areas of isolators. |
Special Software
The special software of the high-end version guides the user by individual menu prompts. Three different programs can be selected: manual operating mode, manual operating mode with data acquisition and automatic operating mode with data acquisition. Data is input using a bar code scanner. Program specific data, such as pump speed, time of the pumping process, etc., can additionally be manually or automatically logged. The user's special SOPs can be saved in additional programs and stored on a PC, then downloaded to the Sterisart Universal pump so that the user can routinely recall and run these SOP programs.
The complete process sequence of the sterility test can optionally be documented by a PC with special evaluation software, which facilitates the user's compliance with directives and guidelines for traceable documentation.
Specs
| Pump Specifications |
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| Dimensions (WxHxD) | 420 x 220 x 120 mm |
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| Weight | approx. 11 kg |
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| Voltage | 90-230 VAC (alternating voltage) |
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| Tolerance range |
acc. to VDE -15% / +10% |
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| Frequency | 47-63 Hz |
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| Power Consumption |
100 W |
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| Fuse | T 1.6 A |
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| Pumping performance |
10-700 mL/min (dependent on the tubing) |
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| Noise level at 1 m distance |
45 dB(A) |
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| Tubing System |
Proper funtioning of the Sterisart Universal pump is only guaranteed with tubing systems which have been found to be acceptable by Sartorius | ||||||
| Ambient temperature |
+10oC - +40oC |
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| Protection class |
IP 20 |
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| Cooling | Self-convection and ventilator |
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Options
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Application |
Sterisart Type |
Description |
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Liquid Closed bottles LVP w/rubber septum |
16466-ACD/GBD | Dual-needle metal spike for closed large volume parenteral (LVP) containers. Available as ETO or Gamma sterilized |
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Liquid Close bottles SVP w/rubber septum |
16476-ACD/GBD |
Short dua-needle and metal spike for closed containters. Available as ETO or Gamma sterilized |
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Liquid Open bottles |
16467-ADC/GBD | 6 cm metal spike for open containers. Available as ETO or Gamma sterilized |  |
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Medical Device Collapsible bags, luer lock connectors, etc. |
16468-ACD/GBD | Adapter for medical devices with luer or luer lock connectors. Available as ETO or Gamma sterilized |
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| Antibiotics and powders | 16467-ACD/GBD | 6 cm metal neede for open containers. Available as ETO or Gamma sterilized | |
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Powders Easy to dissolve |
16475-GBD |
System for lyophilized or soluble powders in un-vented vials. Gamma sterilized |  |
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Powders Difficult to dissolve |
16470-GBD | System for difficult-to-dissolve powders in un-vented vials. Gamma sterilized |
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| Pre-filled syringes |
16469-GBD | System with adapter for pre-filled syringes. Gamma sterilized |
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