The use of sealed isolators must strictly follow the following precautions to ensure a sterile environment and safe operation:
1、 Preparation before operation
1. Personnel training
Operators need to receive professional training, be familiar with the structure of isolators, principles of airflow control, and sterilization processes, and possess emergency response capabilities.
2. Equipment inspection
Confirm the sealing of the isolator, check if the door lock, quick transfer compartment, and pressure sensor are functioning properly.
Verify whether the positive pressure value (usually 17.5-50Pa) and airflow mode (turbulent or unidirectional flow) meet the design requirements.
2、 Sterilization and Material Transfer
1. Sterilization requirements
Before use, 35% food grade hydrogen peroxide (300-700ppm) should be used for 25 minutes of sterilization, and the effect should be verified through a chemical indicator card.
2. Material Management
All materials entering the isolator must be pre sterilized and transferred through a rapid transfer chamber or dedicated sterilization channel, and direct contact with the external environment is prohibited.
3、 Operation monitoring
1. Environmental maintenance
Real time monitoring of pressure difference and cleanliness (internal must reach ISO5 level) to prevent backflow of external air.
Regularly check the efficiency of HEPA filters to avoid air stagnation and pollution.
2. Operation restrictions
Personnel are prohibited from directly entering the isolator during operation, and all operations must be completed through a glove box or remote control.
4、 Maintenance and recording
1. Regular maintenance
Clean the inner wall of the isolator (it is recommended to use stainless steel or glass material), check the aging of the seals, and replace worn parts in a timely manner.
2. Data recording
Complete recording of sterilization parameters, pressure difference changes, and abnormal events to provide a basis for subsequent validation.
5、 Security protection
1. Biosafety isolators require additional negative pressure locks and personnel protective equipment to prevent the leakage of harmful substances.
2. In case of malfunction, immediately activate the emergency plan and prioritize maintaining the airtightness of the isolator.
The above measures can ensure the sterile environment stability and operational safety of the sealed isolator.