The rigid compartment laminar flow sterile isolator is a hard wall structure composed of stainless steel and tempered glass, with a dynamic Class A internal environment. Use gloves for operation, which can be selected from thick, anti damage or thin, with a high tactile feel; The system is equipped with a Siemens logic controller (PLC) for fully automated control of pressure and air supply, and has a pressure loss alarm function. Industrial grade tablet computer control, compliant with the 2010 GMP computer system validation requirements.

1. Dry vaporized hydrogen peroxide (VHPS *) sterilization, achieving a 6-log spore killing level, with hydrogen peroxide concentration monitoring and control functions;

2. Clean the interior of the cabin manually without any dead corners;

3. After ventilation, the VHPS concentration in the cabin is less than 1ppm, which can meet the detection of residual VHPS concentration;

After sterilization, the cabin fully meets the GMPA level cleanliness standard and can be integrated with an online dust particle and planktonic bacteria sampling system;

5. Cabin depressurization test, with an hourly volume leakage rate of less than 0.5% under 2 times the test pressure; Equipped with leak alarm function;

6. The isolator can be adjusted from -80pa to 80pa according to usage needs. During sterile operation of conventional products, it maintains a pressure of 40pa to 60pa. Under static conditions, the pressure is maintained at the set value ± 5pa. The positive and negative pressure modes can be pre-set and stored, and adjusted according to demand;

7. The system design complies with GMP, 2015 Pharmacopoeia, USP/EP requirements, and the control system can meet the electronic signature and electronic record requirements of 21CFR part 11;

8. The gas source is clean filtered compressed air or nitrogen, with a pressure of 0.4MPa~0.6MPa.

Power supply: 380 ± 38V, 50 ± 5Hz, 25A (HTY-1800G4/HTY-1800AG4)

Maximum power; ≤ 4000W(HTY-1800G4/HTY-1800AG4)

Built in bacterial collection device: 1 or 2 units

Airflow mode: unidirectional flow

Equipped with a 12.1-inch industrial tablet computer/NetSCADA system

Aseptic maintenance work noise<65dB (A)

Other specifications can be customized according to customer requirements

Used for aseptic filling, sampling, inspection, freeze-drying, and liquid preparation.