Product details
Sterility Test Isolator
TAILIN sterility test isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity.
It is (laminar flow aseptic isolator) composed of stainless steel and toughened glass.
It is Class A inside.
The system is equipped with Siemens (PLC) for fully automatic control.
All the sterility test isolators meet the GMP requirements.
Experience:
The core competency of TAILIN is technological innovation and strong manufacturing ability. Actually, the first Biological Isolator in China was developed by TAILIN. This program was included in the National Torch Plan by the Ministry of Science and Technology of China. For now, TAILIN has 20 years experience in aseptic isolator manufacturing.
Features:
1. Built-in Vaporized Hydrogen Peroxide (VHPS) generator for bio-decontamination which can reach 6-log Sterility Assurance Level
2. The VHPS residual concentration is less than 1ppm after aeration
3. leakage rate is less than 0.5% /vol/hour under 2 times working pressure test
4. Pressure is adjustable within -80pa~80pa
5. 12.1” IPC with NetSCADA
6. Built-in Sterility Test Pump
7. Comply with 21 CFR Part 11 electronic records and signature requirements;
8. GMP, USP, EP compliance
9. Interlock, alarms record and audit trails
10. Noise: ≤65dB(A) when in pressure hold stage
11. Compressed air supply: 0.4MPa~0.6MPa clean and dry
12. Power Supply: 380±38V,50±5Hz,25A ( HTY-1800G4/HTY-1800AG4)
Options：
Air Sampler, Particle Counter
High / low concentration sensor
Portable concentration sensor for operator safe
WiFi controlled glove integrity tester (GIT-WLAN)
Wooden Mock-Up
Services：
Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11
FAT, SAT, Training
http://www.tailinscitech.com/
