In depth Analysis of Sterile Isolators
Aseptic isolators are enclosed spaces composed of rigid and/or flexible barrier materials. They contain an integrated vaporized hydrogen peroxide (VHP) sterilization system, which can repeatedly sterilize the air inside the isolator and effectively exposed surfaces to remove the bioburden. After sterilization, air exchange can be carried out through high - efficiency particulate air (HEPA) filters, and the pressure inside the chamber can be kept constant to prevent external contamination.
The aseptic isolation system mainly includes the operation chamber, VHP sterilization system, air - handling system, material - in - and - out and transfer door system, instruments and other related components. Through well - designed closed - air - flow systems, positive - pressure protection systems, sterilization systems, and transfer systems, the contact probability between personnel and test samples is minimized, and the risk of contamination, especially the risk of false positives, is avoided. Regarding the operation chamber, the selection of its material is crucial. Materials with high strength, chemical - resistance, and good sealing properties are usually chosen to ensure long - term and stable isolation performance. The internal structure of the chamber is carefully designed with a rational spatial layout to make the operation process smooth and reduce potential pollution hazards. The inner surface is specially treated to be smoother for easy cleaning and disinfection and to prevent the attachment of microorganisms and impurities.
The VHP sterilization system is characterized by precision and controllability. It can accurately release vaporized hydrogen peroxide according to the set program, precisely control the concentration, distribution, and action time to ensure the sterilization effect and avoid adverse effects of hydrogen peroxide residues on test samples or subsequent operations. It is also equipped with advanced monitoring devices to monitor key parameters in real - time. In case of abnormalities, it can give timely alarms and take corrective measures.
Apart from HEPA, the air - handling system includes functional modules such as air circulation, temperature and humidity regulation. Air circulation ensures the uniform mixing of air inside the chamber, enabling the sterilized and filtered air to quickly fill the chamber and maintain a clean environment. Temperature and humidity regulation can control the environment inside the chamber according to the test requirements because changes in temperature and humidity may affect the growth of microorganisms and the stability of certain test samples.
The material - in - and - out and transfer door system has strict design standards. The doors adopt special sealing structures and interlocking devices so that the tightness of the isolator will not be damaged during material transfer. When one door is opened, the other one is automatically locked. Moreover, the material transfer interface is specially designed to disinfect the incoming and outgoing materials, such as ultraviolet irradiation, chemical spraying, etc., reducing the risk of contamination.
Instruments play a crucial role in aseptic isolators. Pressure sensors accurately measure the pressure inside the chamber to ensure the stable operation of the positive - pressure protection system. Microbial detection sensors monitor the change in the number of microorganisms inside the chamber in real - time, providing data support for the evaluation of the sterilization effect and subsequent operations. There are also display instruments that visually present system parameters for the convenience of operators to monitor and adjust.
Suzhou Pharma Machinery Co.,Ltd.
2025/05/08
Mia
