The laminar flow aseptic isolator composed of stainless steel and toughened glass.  It is Class A inside.

The system is equipped with Siemens (PLC) for full automatic control.

Comly with GMP, EP, USP,CP

According to GMP, the sterility test is allowed to be made in the sterility test isolator which is installed in the Class D background.

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.   Built-in Glove Integrity Tester (HTY-GIT01INS);

8.   Comply with 21 CFR Part 11 electronic records and signature requirements;

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

Aseptic filling, sampling,sterility testing, compounding and dispensing.

* Size can be customized

Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11.

FAT, SAT, Training.