sterility testing of medical devices sterility test validation minisart

A one-time use of a fully enclosed collection culture incubator. sterility test pump Integral stainless steel casing design: All use L304 sanitary grade stainless steel to solve the requirements of the clean room. Microbial chamber high clean instrument. Improve the service life of the instrument and reduce the cost of repair, replacement, etc. caused by rust on the surface of the traditional collection instrument. It avoids the corrosion of the surface of the chemical, and the design of the surface of the casing does not leave any dead angle. Through the principle of directional peristaltic pressure of the collecting instrument, the microorganisms in the test sample are trapped in the microporous membrane of the filter at 0.22μm*47mm or 0.45μm*47mm, and the bacteriostatic components are removed by rinsing the filter, and then the desired The culture medium is directly introduced into the fully enclosed filter collection incubator through the injection pipeline, and placed in an incubator for aseptic culture.

1. sterility test pump scope sterility test pump

WINTEAM intelligent collection instrument is a special instrument for clinical detection of body fluid bacteria, sterility detection and microbial limit detection in the fields of medicines and biological products.

2, the working principle of the sterility test pump

YT series intelligent bacteria collection instrument is a supporting product for one-time trial use of fully enclosed bacteria collection filter culture incubator. The test sample is filtered by 0.45 or 0.22 filter membrane through the principle of directional peristaltic pressure of intelligent bacteria collection instrument. The bacteria in the filter are trapped on the filter in the filter, and the bacteriostatic component is removed by rinsing the filter. Then, the required culture medium is directly introduced into the collection culture incubator through the sample introduction tube, and placed in an incubator for aseptic culture.

3, sterility test pump structure

The WINTEAM sterility test pump consists of a main unit, a suspension bracket, a drain tank, a foot switch and a peristaltic pump head.

1. Ultra-small design reduces the space and airflow interference of the ultra-clean console;
2. The waterproof design of the fuselage prevents liquid from penetrating into the interior of the instrument;
3. Large LCD display, operating status indication function, clock function;
4. Four-speed direct speed control with speed memory function;
5. The stainless steel case is mirror polished for easy cleaning and disinfection.
6. The stainless steel case meets the requirements of the experimenter for the sterile laboratory;
7. Phase voltage control stepless speed regulation operation control is convenient;
8. Turbine deceleration system, reduce machine working noise, increase torque capacity to ensure safe operation;
9. Turbine deceleration system The power system uses high power to ensure high viscosity sample experiments and increase speed.

4, sterility test pump control instructions

4.1 Overview of the sterility test pump

Promise split-type digital governor, perpetual calendar clock, speed/clock LCD with backlight and wide vision.

4.2 fsterility test pump display and operation

(1) After turning on the power, press the gear speed control selection button to enter the interface, the device starts running and displays the current speed.

(2) When the equipment is running, press ▲ or fine-tune the speed to adjust to the required speed.

(3) When the test article is finished filtering or needs to stop midway, press stop or the foot pedal switch.

4.3 sterility test pump working environment

(1) Environmental requirements: in a clean laboratory or in a clean bench.

(2) Ambient temperature: 4 ° C ~ 25 ° C

(3) Relative humidity: ≤90% RH or less (anhydrous beads condensation phenomenon)

(4) Working power supply: 220V/50HZ

(5) Electrical safety: The instrument requires grounding and reliable grounding. The grounding impedance is ≤ 4n, and the wire diameter of the grounding wire is 1.6mm or more.