Why Use Isolation Technology
Sterile isolator is composed of sterilization experimental chamber, two chambers of transfer chamber and vaporized hydrogen peroxide sterilizer,
The transfer cabin sterilizes the samples (with packaging containers), inspection tools, culture media and buffer solution (sterilizes surface microorganisms with vaporized hydrogen peroxide gas),Sterility inspection (or microbial limit inspection) shall be carried out after entering the experimental chamber through RTP sterile transmission.
The isolator adopts a hard cabin (or soft and strong) body structure. The interior material of the cabin is 316 stainless steel or non-toxic PVC, and the exterior material of the cabin is stainless steel 304 or non-toxic PVC.
The cabin cleanliness meets the requirements of GMP Class A. The control system can perform automatic control operation and operation detection.
The transfer of internal materials is carried out through the gloves provided by the isolator (gloves need to be regularly tested for leakage, pressure attenuation method).
After sterilization, internal purification shall be carried out through the high efficiency filter H14 at the inlet and outlet, so as to maintain the Class A laminar flow (or turbulent flow) inside the cabin.
The bacteria collecting instrument is integrated in the experimental cabin for drug sterility inspection and microbial limit inspection. After the inspection, the isolator is sent out through the outer door.
Why use isolation technology
Compared with the final sterilization products, there are more variables in the sterile operation process of non-final sterilization products.Every error in the operation process may cause product pollution.Some manual or mechanical operations have a great risk of contamination during aseptic operation.The need to protect products and operators.
Operating steps of Sterile isolator
Step 1: Entry of test articles and inspection tools
Step 2: Preparation before sterilization
Step 3: dehumidification - regulation - sterilization - ventilation and residue removal
Step 4: Experimental operation
Suzhou Pharma Machinery Co.,Ltd.
2023/03/13
Spencer
