Compounding Aseptic Containment Isolater Sterility Test Isolator

The aseptic inspection isolator is a device used to ensure that the sample is completely isolated from the external environment during the sterility test. Such isolators are commonly used in the pharmaceutical, biotechnology and medical industries to ensure that products or materials are tested under sterile conditions to avoid any possible contamination. The isolator provides a special testing environment for the sterility test process through a hardware isolation barrier. In this environment, the operator can perform physical operations through gloves, while the biological side is effectively isolated, thus ensuring the authenticity of the inspection results. Aseptic inspection isolators are essential to ensure product quality, especially under Good Manufacturing Practice (GMP) specifications. It helps ensure that medicines, medical devices and other products requiring strict aseptic conditions meet the appropriate safety standards.

Features and advantage:

• High Efficiency Particulate Air (HEPA) or higher ensures that the air entering the isolator is highly purified.
• Positive pressure control: The internal positive pressure is maintained to prevent outside unfiltered air from entering the isolator.
• Handling gloves/sleeves: Allow workers to operate without direct contact with items, reducing the risk of contamination.
• Transfer compartment: A specially designed transfer window or compartment facilitates the safe feeding and removal of the sample to be tested into and out of the isolator while maintaining a sterile state.
• Easy cleaning and disinfection: The structural design takes into account the need to facilitate thorough cleaning and sterilization, such as the use of removable parts.
• Monitoring system: equipped with temperature, humidity, pressure and other parameter monitoring devices, and can record relevant data for traceability analysis.
• Improved testing efficiency: By providing a dedicated, isolated environment for sterility testing, the testing efficiency is effectively improved.
• Ensure the authenticity of test results: The accuracy of sterility test results is ensured through hardware isolation barriers and effective biological side isolation.