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 very strict condition. Working together with sterility test device.
Gamma irradiated sterilization
＊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 cycle scale abd 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 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.
◆ 7inch capacitive touch screen, supply good user experiences for information display and input.
◆Whole mirror polished stainless steel process, easy to clean and disinfection.
◆ Drain tray can be hang on and lay on the table. Drain tray container is designed to be integral whole processing molding with big internal arc angle, easy to clean and disinfection
◆ Palm design bottle holder, for laying the testing bottle and medium bottle. Its hook deign for soft pouch. Adjust the height of holder freely.
◆ Accept program SOP in system, operation normalization.
◆ Label print and stick, each canister body have relative stick label after testing, identifying standardization
◆ Footswitch has two modes. Suit for different switch control requirement for LVP testing sample and Small volume testing sample.
◆ Switch setting of Cooling fan, ON or OFF according to the heating situation of engine.
Rotate speed: up to 240rpm
Power: AC 220V/110V, 50/60Hz, 150W
—sterility test for pharmaceutical drug
—sterility test for medical apparatus
—sterility test for supplementary material and packing material.