Taylor BioTECH
Filter
Showing the single result
| Brand | Taylor BioTECH |
|---|---|
| Model | TECHLEAD® BIT-L01 |
| Origin | Zhejiang, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic Pharmaceutical Testing Instrument |
| Compliance | USP <1207.2>, NMPA CDE Guidance on Container Closure Integrity Testing (CCIT) for Injectable Products, GAMP 5, Biosafety Level 2 (BSL-2) compatible |
| Data Integrity | 21 CFR Part 11–compliant audit trail, role-based three-tier user access control |
| System Architecture | Modular design with separable test chamber and control unit |
| Automation | Fully automated CCIT cycle including vacuum priming, microbial suspension delivery, pressure challenge, effluent evacuation, and in-situ chamber cleaning |
| Chamber | High-temp resistant borosilicate glass test vessel (max. 121°C autoclave-compatible), fully sealed during operation |
| Connectivity | USB 2.0 data export port, integrated thermal line printer |
| Software | Embedded OS with recipe management, real-time process monitoring, immutable data logging, and PDF report generation |