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Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator
Rigid Sterility Test Isolator


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.


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.   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



Applications

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

Specifications

ModelDescription

Overall Dimensions (L*W*H)

Operating SpaceInner Pass Box
HTY-1250G2

Main Chamber + Pass Box

- Single Side

2300*870*2420 mm1240*680*700 mm600*550*700 mm
HTY-1250AG2Main Chamber - Single Side1670*870*2420 mm1240*680*700 mm          /
HTY-1650G3

Main Chamber + Pass Box

- Single Side

2700*870*2420 mm1640*680*700 mm600*550*700 mm
HTY-1650AG3Main Chamber - Single Side2075*870*2420 mm1640*680*700 mm        /
HTY-1800G4

Main Chamber + Pass Box

- Single Side

2850*870*2420 mm1790*680*700 mm600*550*700 mm
HTY-1800AG4Main Chamber - Single Side2225*870*2420 mm1790*680*700 mm       /
HTY-1800G8

Main Chamber + Pass Box

- Double Side


2650*1240*2420 mm1750*1200*650 mm600*550*700 mm
HTY-1800AG8Main Chamber - Double Side2370*1240*2420 mm1750*1200*650 mm       /

* Size can be customized

Services

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

FAT, SAT, Training.

 

 

Technical specifications are subject to change without notice. Copyright reserved by Tailin.