Sterility Test Canister
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.
Features
- 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 LayerPouch Package (E-beam Sterilized) | Feature | |
---|---|---|---|---|---|
LVP in | W/O Antibiotics | PY220 | B-PY220 | PY220D | Side hole and double core needle |
Bottle | With Antibiotics | KSF220 | B-KSF220 | KSF220D | Longer tube and can be used together with HTY- shaker |
Liquid in | W/O Antibiotics | APY220 | B-APY220 | APY220D | Longer needle which could |
Ampoule | With Antibiotics | KAPY220 | B-KAPY220 | KAPY220D | transfer the samples quickly |
Powder | W/O Antibiotics | DGB220 | B-DGB220 | DGB220D | Double needle adapter which could realize dissolution, |
in Vial | With Antibiotics | KDGB220 | B-KDGB220 | KDGB220D | filtration and flush at the same time |
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 | - | CN220D | 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 | DGB203 | - | DGB203D | Needle-inside-Needle | |
KDGB203 | - | KDGB203D | design |