Sterility Test System
Compliance with regulatory requirements in ChP, USP, EP and JP.
Sterility Test Closed Canister
Sterility Test Closed Canister is used for pharmaceutical product sterility test by the membrane filter method Which produced in high strict condition. Working together with sterility test device.
Sterilization
Gamma irradiated sterilization
Feature
＊Adopt all imported original pharmaceutical grade material, without chemical releasing.
＊Ultrasonic welding process, avoiding side leakage accident.
＊Chosen membrane avoiding adsorption of drugs.
＊Designed wrench style clasp, easy to control the flow rate.
＊Connected single use sealing lock clasp in the tube, easy to control.
＊Sealing stopper for top and bottom designed with two wings of ergonomics.
＊Imported adhesive paper of sealing package, avoiding false positive result by sterilization and false negative result by EtO.
＊Double package including certain negative pressure, eliminating the risk of false positive and false negative.
＊Each set of closed canister package all have sterilization indicator card inside, giving visual clearly instruction of its sterilization result.
＊Having 50ml, 86 cycle scale and 100ml alarm line in the canister body.
＊The color of wrench style clasp is same as single use sealing clasp in one tube which easy discriminate different tubes.
Sterility Test Device
SM86
SM86 sterility test system is used for sterility test in sterile product.It can work with all kinds of closed canister. Many types of sterile products can be tested with the SM86 sterility test system, including:
◆ LVP(Large Volume Parenteral) in Glass bottle, plastic bottle, soft pouch, etc.
◆ Injection in Ampoule and vial, and freeze-dried powder
◆ Insoluble powder
◆ Medical devices
◆ Preloaded syringe
It is to test whether testing sample contains microorganisms. The microorganisms present in the sample are captured on the microporous membrane in the closed canister by the action of directional peristaltic pressure from the SM86 pump device. Rinsing membrane to remove the bacteriostatic ingredient if samples included. Appropriate medium is pumped into each canister separately to promote the growth of the captured organisms. The canisters are incubated and examined for contamination in accordance with the relevant pharmacopoeia.
Feature
1. The unique label print function, connect with the printer, can print the relevant information of the experiment to the sticker and stick it on the canister body directly, which avoids the traditional method of hand-writing on the canister body and improves the standardization of the labeling of experimental data.
2. 7inch capacitive touch screen, supply good user experiences for information display and input.
3. Whole mirror polished stainless steel process, easy to clean and disinfection.
4. Two operation mode: Program operation and Direct operation.
5. Equipped with medical waterproof footswitch, intermittent operation and continuous operation of 2 modes.
6. Run is quickly and speed is stable.
7. Drain tray can be hang on and lay on the table.When it is hanged on, more than 180 angle for choice.
8. Side installed with pushbutton power switch with light.
9. Bottle holder can meet the demand on hanging for the pouch.
10. English and Chinese operation language for choice
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Technical Parameter
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Voltage
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220V\110V±10%，50/60Hz
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Total power
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120W
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Pushbutton power switch
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Waterproof button switch with light
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Printer inlet
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5 core waterproof aerial plugt
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Footswitch inlet
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3 core waterproof aerial plug
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Rotation speed
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Up to 240rpm
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Prestore SOP information
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50pcs
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Touch screen
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7inch Industrial touch capacitive screen
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Operating language
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Chinese \ English
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Pump housing
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304 stainless steel mirror polished
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Drain tray support
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316L stainless steel mirror polished
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Drain tray container
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PPSU
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Weight of pump device
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14.8Kg
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Pump device size (mm)
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610×380×420 （W×D×H）
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Printer device size (mm)
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133×186×128 （W×D×H）
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Print paper size (mm)
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50×25 （W×L ）
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Application
—sterility test for pharmaceutical drug
—sterility test for medical apparatus
—sterility test for supplementary material and packing material.