Brand Name: | GEEVO |
---|---|
Type: | Bacteria Analysis System |
Range: | for drug test |
color: | transparency |
weight: | 1g |
Place of Origin: | China (Mainland) |
Model Number: | types |
spec.: | 0.45um |
Quick Details
Specifications
Sterility Test System
Compliance with regulatory requirements in ChP, USP, EP and JP.
Sterility Test Closed Canister
Gamma irradiated sterilization
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.
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.