GMP regulations require:
Sterility testing is a mandatory inspection process prior to product release.
Sterility check isolators will gradually replace the requirements that were previously required to be implemented in a Class B background and a Class A environment.
Advantage:
The isolator adopts ISOLATOR grade, the environment is controlled at A grade, and the large background environment can be applied to the D grade area or CNC environment experiment to ensure the release of drugs. And reduce the operating cost of the environment.
The aseptic transfer is integrated with the hydrogen peroxide sterilization and decontamination technology, which realizes the effective and rapid sterilization of the samples before operation and inspection, and reduces the risk again.
Modular design, selection, loading, and structural combination can be selected according to the customer's inspection batch.
The operation adopts seated operation, which reduces work fatigue and improves human accuracy.
It can meet the operation of toxic materials, and the system can realize the function of filter replacement.