GMP Sterillity Testing Isolator for Factory Aseptic Isolator Negative Pressure with Sterlie Pump

Product Description

Technical characteristics
Automatic leak detection: inflate the cabin to check if the system remains sealed. If the sealing requirements are met, enter the sterilization process. If the sealing requirements are not met, continue to inflate and seal before leak detection
Cycle until the sealing conditions are met. 
Efficient flash evaporation method: A high-precision constant temperature system ensures zero decomposition of hydrogen peroxide during evaporation, and 100% of hydrogen peroxide forms steam. 
Quick residue removal: The configured hydrogen peroxide decomposer not only can quickly and thoroughly decompose spatial hydrogen peroxide, but also can decompose surface hydrogen peroxide residues.
Sterilization process recording: Automatically detect sterilization concentration and draw sterilization process curves.
Door interlock function: The equipment cannot open the doors during operation. 
Interior surface antibacterial treatment: The interior surface adopts antibacterial treatment, which can achieve sterilization and antibacterial effects, making the interior surface permanently free of microbial habitats.
Compliant with computerized verification software: The system has audit tracking, electronic signature, and data integrity functions.
Bottom mounted features: The bottom mounted transmission cabin has a compact structure, a small footprint, and is easy to operate.

Material	External all 304 stainless steel, internal chamber 316L stainless steel
Cleanliness level	Class A
Wind speed	0.45m/s ± 20%
Leakage rate	≤ 0.5% VOL/h (below 100pa)
Exhaust volume	≥ 300m ³/ H
Pressure control range	100pa~+100pa
Sterilization efficiency	6lg
VHP residual removal efficiency	≤ 1PPM
Control method	Manual or automatic
Noise	≤ 68dB (A)
illumination	≥ 350LUX

Model/parameter	Overall dimensions (W*D*H)mm		Operating cabin size (W*D*H)mm		Transmission compartment size (W*D*H)mm	Power supply	Air supply	Explain
STI-1200	1600*880*2250		1195*680*700			AC220V /3.5KW	≥0.6Mpa	Single person single cabin
STI-1200/BPB600	1600*880*2250		1195*680*700		600*680*700			Single person double cabin
STI-1500D/BPB600	2100*1200*2250		1495*1195*700		600*680*700			Single person, double cabin, double sided
STI-1800	2200*880*2250		1795*680*700			AC220V /5.5KW		Double person single cabin
STI-1800/BPB600	2200*880*2250		1795*680*700		600*680*700			Double person single cabin
STI-1800/PB600	2800*880*2250		1795*680*700		600*680*700			Two person, two cabin
STI-1800D/BPB600	2200*1200*2250		1795*1195*700		600*680*700			Double person, double cabin, double sided

 

Aseptic Isolator is a highly clean, continuous and effective operating space brought about by aseptic isolation technology. It can minimize the contamination of microorganisms and various particles, thus improving the accuracy of sterility test

 

Advantage

(1) All work and material handling in the isolator must be isolated and controlled. No person or body part can directly enter the isolator during operation.

 

(2) All materials entering the isolator must be decontaminated or sterilized, and must enter directly through the past pollution or sterilization system, or through the fast transfer cabin.

 

(3) Decontamination methods must be repeatable and quantifiable.

 

There are two simple purposes to use aseptic isolator. One is to protect samples from environmental pollution, which includes pollution from operators and test environment.
The second is to protect operators from the pollution of toxic and harmful substances.
The application of sterile isolator is very wide, especially in the production of sterile prouducts. The application of sterile isolator in the production of sterile products not only ensures the quality of products, but also reduces the cost..