Product IntroductionThe closed-system sterility test canisters are designed for microbiological sterility testing in pharmaceutical and medical applications. The system, used with a sterility test pump, minimizes contamination risk and reduces false results. Models are available to accommodate various sample types and container forms. The product family is certified under ISO 9001 and ISO 14001.
Key Features- Closed-system design with fully enclosed 360° liquid inlet for secure sample transfer.
- Ultrasonic-welded cup construction and high-quality composite tubing for improved sealing and pressure resistance.
- Enhanced mechanical resistance to impact, collision, wear and increased pressure tolerance.
- Transparent cup with clear graduation lines (including 25 mL mark) for easy volume observation.
- Pre-sterilized options by EO or irradiation, meeting CE and international standards.
- Validated by bacterial challenge tests, microbial growth recovery and sterility testing for reliable results.
Additional Product Highlights- Double-layer packaging (inner soft blister tray + outer composite-film Tyvek® pouch) for aseptic depackaging and reduced contamination risk.
- Pop-up cap with lanyard that activates on excess internal pressure and remains attached during testing.
- Pre-installed clamps validated for flow distribution, open/close cycles, sterilization resistance and impact tests for reliable operation.
ApplicationsSterility test canisters are compatible with sterility testing of sterile preparations including antibiotics and bacteriostatic formulations, sterile APIs, intravenous fluids, aqueous injections, sterilized medical instruments, WFI, lyophilized products, prefilled syringes and other pharmaceutical/biotech samples.
Technical specifications- Product type: Closed-system sterility test canisters for microbiological sterility testing.
- Packaging: Double-layer (inner soft blister tray + outer DuPont™ Tyvek® composite-film dialysis pouch).
- Sterilization: EO pre-sterilized or irradiation pre-sterilized options.
- Material & construction: Ultrasonic-welded cup, high-quality composite tubing, fully enclosed 360° liquid inlet.
- Mechanical properties: Enhanced impact, collision, wear and pressure resistance; improved transparency and clear graduation lines (including 25 mL mark).
- Accessories & design: Pop-up cap with lanyard; pre-installed clamps validated for flow distribution and sterilization resistance.
- Certifications: ISO 9001, ISO 14001.
- Validated tests: Bacterial challenge test, microbial growth recovery, sterility tests.
- Chemical compatibility: Compatible with a broad range of disinfectants and solvents.
- Model family / available models: PY2202*, PY2202D*, PY220, B-PY220, PY220D, KSF220, B-KSF220, KSF220D, APY220-P*, APY220, B-APY220, APY220D, KAPY220, B-KAPY220, KAPY220D, DGB220, B-DGB220, DGB220D, KDGB220, B-KDGB220, KDGB220D, DGA220, DGA220D, KDGA220, KDGA220D, NKF220, B-NKF220, NKF220D, SDY220, B-SDY220, SDY220D, YLQ220*, YLQ220D*, YLX220*, YLX220D*, CN220, B-CN220, CN220D, DCN220, DCN220D, PFS2*, PFS2D*, EVS2. ("*" denotes customized model.)