Complaint
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
| Model | Description | Overall Dimensions (L*W*H) | Operating Space | Inner Pass Box |
|---|---|---|---|---|
| HTY-1250G2 | Main Chamber + Pass Box - Single Side | 2300*870*2420 mm | 1240*680*700 mm | 600*550*700 mm |
| HTY-1250AG2 | Main Chamber - Single Side | 1670*870*2420 mm | 1240*680*700 mm | / |
| HTY-1650G3 | Main Chamber + Pass Box - Single Side | 2700*870*2420 mm | 1640*680*700 mm | 600*550*700 mm |
| HTY-1650AG3 | Main Chamber - Single Side | 2075*870*2420 mm | 1640*680*700 mm | / |
| HTY-1800G4 | Main Chamber + Pass Box - Single Side | 2850*870*2420 mm | 1790*680*700 mm | 600*550*700 mm |
| HTY-1800AG4 | Main Chamber - Single Side | 2225*870*2420 mm | 1790*680*700 mm | / |
| HTY-1800G8 | Main Chamber + Pass Box - Double Side
| 2650*1240*2420 mm | 1750*1200*650 mm | 600*550*700 mm |
| HTY-1800AG8 | Main Chamber - Double Side | 2370*1240*2420 mm | 1750*1200*650 mm | / |
* Size can be customized
Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11.
FAT, SAT, Training.
