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The complete sterility test system includes the Sterility test pump and sterility test canisters. It is a closed system to minimize the risk of false positive and negative results, increasing reliability and improving workflow for sterility testing. Steriltalin? sterility test canisters provides many kinds of test kits to fit for variety of drugs and packages.
Design based on end-user comments to improve the working efficiency.
Ultrasonic welding;
100% membrane and canister integrity test;
Bacterial challenge test;
Microorganism regrowth and sterility test;
EO sterilization or E-beam sterilization;
Sterilization process and validation comply with ISO11135/ ISO11137;
COA and Validation documents are available.
Applications | Single Layer Pouch package (English-Chinese) | Blister Package (English-Chinese) | Double Layer Pouch Package (E-beam Sterilized ) | Feature | ||
LVP in Bottle | W/O Antibiotics | PY220 | B-PY220 | PY220D | Side hole and double core needle | |
With Antibiotics | KSF220 | B-KSF220 | KSF220D | Longer tube and can be used together with HTY-K shaker | ||
Liquid in Ampoule | W/O Antibiotics | APY220 | B-APY220 | APY220D | Longer needle which could transfer the samples quickly | |
With Antibiotics | KAPY220 | B-KAPY220 | KAPY220D | |||
Powder in Vial | W/O Antibiotics | DGB220 | B-DGB220 | DGB220D | Double needle adapter which could realize dissolution, filtration and flush at the same time | |
With Antibiotics | KDGB220 | B-KDGB220 | KDGB220D | |||
Insoluble Powder in Vial, With Antibiotics | NKF220 | B-NKF220 | NKF220D | Three needle adapter which could realize dissolution, dilution filtration and flush at the same time | ||
LVP in Soft Pouch | SDY220 | -- | SDY220D | Larger diameter side hole needle | ||
Medical Instrument with Catheter (Infusion Set, Transfusion, Dialysis Tubing and Intravenous Tubing etc.) | YLQ220 | -- | YLQ220D | Special connection to connect the medical instruments | ||
Soluble Powder in Ampoule | DGA220 | -- | DGA220D | Single controllable needle design which could dilute and filtrate at same time | ||
Viscous Liquid (biological products) | CN220 | -- | CN2220D | Reinforced filtration membrane | ||
Lyophilized Powder for Injection （biological products) | DCN220 | -- | DCN220D | Increase dissolution tube, reinforced filtration membrane. | ||
Pre-filled syringe | PFS2 | -- | PFS2D | Can be used with a variety of pre-filled syringes to transfer. Closed system, effectively reduce the risk of contamination | ||
Emulsion or hard filtrating aqueous samples
| -- | EVS2 | -- | High flow rate filtration membrane with protective padding | ||
Small Volume Parentera in vial less than 5mL | W/O Antibiotics | DGB203 | -- | DGB203D | Needle-inside-Needle design | |
With Antibiotics | KDGB203 | -- | KDGB203D | |||
Used together with the sterility test pump for sterility testing of sterile products.
Technical specifications are subject to change without notice. Copyright reserved by Tailin.