ZHEJIANG TAILIN BIOENGINEERING CO.,LTD

TAILIN can manufacture all the critical components in the isolator, i.e. VHPS generator, Sterility test pump,sterility test canisters;

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.

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