Pharmaceutical
STERILITY TEST ISOLATOR
TAILIN make Sterility Test Isolator
High Performance
Industry leading accuracy
FDA Compliant
21 CFR Part 11 ready
Expert Support
24/7 technical assistance
Available Pan India
Products available across the country
Product Overview
The TAILIN make Sterility Test Isolator is a Class A laminar-flow aseptic isolator built with stainless steel and toughened glass. Designed for sterile testing systems, it ensures process integrity by providing a fully enclosed, GMP-compliant environment controlled via Siemens PLC systems
- Total Containment: Class A isolator design ensures contamination-free sterility testing.
- Reliability & Compliance: Engineered for GMP environments with validated electronic documentation.
- Operational Safety: Featuring comprehensive interlocks, alarms, and audit functionality.
- Compliance-Ready: Meets GMP, USP, EP, and supports 21 CFR Part 11 for electronic records and signatures
Optional Add-Ons & Services
- Add-ons: Air samplers, particle counters, high/low concentration sensors, portable sensors, Wi-Fi controlled glove integrity tester (GIT-WLAN), and wooden mock-ups.
- Support Services: Comprehensive validation support including FAT, SAT, training, and 21 CFR Part 11 compliance protocols
Key Features
Built-in VHPS Generator: Achieves a 6-log Sterility Assurance Level for robust bio-decontamination.
Safe Residual Levels: Post-decontamination VHPS residual is kept below 1 ppm.
Integrated Test Pump: Built-in sterility test pump enhances workflow efficiency
Enhanced Safety: Equipped with interlocks, alarm records, and audit trails for secure operation.
• Intuitive Interface: 12.1” IPC with Net SCADA for user-friendly operation.