CN
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.