A single-use integrity tester is a specially designed device intended to address the risks of fluid leakage and microbial contamination that may arise in single-use systems, which is critical for ensuring product safety and compliance. Developed specifically to address the challenges of integrity testing in single-use systems, this device effectively prevents product waste and safety hazards. It is used to perform integrity testing on single-use systems (SUS) during the processing of active pharmaceutical ingredients (APIs) and finished pharmaceutical products, including applications such as storage bags, single-use bioreactors, and cell factories.
- Equipped with a 10.1-inch large color touch screen, ensuring comfortable and smooth operation for the disposable integrity tester.
- Comes with 1 or 2 test ports to significantly improve testing efficiency of disposable system integrity detection.
- Each test port works independently, supporting simultaneous testing of disposable systems with the same or different models/specifications, and each port stores independent test data.
- Barcode/QR code scanning function (via scanner) for easy and safe product information entry, simplifying operation in disposable integrity testing.
- Three-level user rights (administrator, processor, operator) to fully meet GMP computer rights management requirements for biopharmaceutical and medical beauty scenarios.
- Built-in test drain function: actively pumps and quickly discharges residual gas in disposable systems after testing, ensuring test accuracy.
- Supports recipe management, logging, recipe selective download, and PDF electronic test reports, complying with relevant regulatory requirements.
Biopharmaceutical Industry
Integrity testing of single-use bioreactors, storage bags and process disposable systems for vaccine, antibody and biologic manufacturing.
Pharmaceutical API & Finished Product Production
Leakage and airtightness verification of single-use assemblies used in API synthesis and finished pharmaceutical processing.
Medical Aesthetics & Cosmetic Biomaterials
Compliance integrity inspection of disposable systems for aesthetic raw materials and biological essence production.
Cell Biology & Life Science Research
Integrity validation of cell factories and cell culture single-use consumables for laboratory and pilot trials.
Bioprocess Engineering & Pilot Manufacturing
Routine integrity testing of disposable process equipment in small-batch production and process scale‑up.
GMP Regulatory Quality Control
Standardized SUS integrity testing, meeting GMP, audit trail and electronic record compliance requirements.
Biomedical Consumables Industry
Factory outgoing inspection and performance verification of single-use bioprocess packaging and components.
Parameter | Specification |
Number of test ports on a single host | 1 or 2 test ports |
Sensor Accuracy | 0.1% FS |
Detection Accuracy | ≥30μm |
Test Range | 0~10 kPa |
Air Input Pressure | 0.4~0.6 MPa |
Power Supply | AC 220V, 50Hz |
Power | 120W |
Weight | 18 kg |
Dimension (W×D×H) | 315 × 420 × 385 mm |
This specialized integrity testing equipment is designed to address leakage risks and microbial contamination issues in single-use systems (SUS), ensuring compliance with pharmaceutical production standards.
A single-use integrity tester is a specially designed device intended to address the risks of fluid leakage and microbial contamination that may arise in single-use systems, which is critical for ensuring product safety and compliance.
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