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0Suitable for work with API / HAPI and for personnel protection. Commonly used for “C” and “D” classes of cleanliness where the direction of airflow is not clearly defined. The air flows in an irregular direction from the air supply inlet to the air outlet through cylindrical HEPA filters H14 at a filtering efficiency of 99.995%. The rate of air exchanges of clean air into the chamber usually ranges from 5 to 40 exchanges per hour. Leak tightness class 3 according to ISO 10648-2“C” Class cleanliness according to EU GMP standard“Audit Trail” compliantElectronic control system fo
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0Asepticfilling, sampling,sterility testing, compounding and dispensing The laminar flow aseptic isolator composedof 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 isallowed to be made in the sterility test isolator which is installed in theClass D background. Features 1. Built-in Vaporized HydrogenPeroxide (VHP) generator for bio-decontamination which can reach 6-log SterilityAssurance Level; 2. The VHPS residualconcentration is less than 1ppm after
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