Marya GMP Standard Cell Drug Preparation Isolator with Intelligent Control System
Description:
This Cell Preparation isolator is meticulously designed to meet the stringent requirements of Good Manufacturing Practice (GMP) in the field of cell drug preparation. It features an intelligent control system that offers precise and reliable regulation of various parameters. It provides a controlled and sterile environment, minimizing the risk of contamination during the cell drug preparation process. The system is capable of maintaining optimal temperature, humidity, and air quality levels, ensuring the stability and integrity of the cell drugs being processed.
Function and Role
Providing Sterile Environment: It effectively prevents external microorganisms, dust and other contaminants from entering the working area, ensuring that the cell preparation process is carried out under strict sterile conditions, reducing the risk of cell contamination and improving the quality and safety of cell products.
Protecting Operators: For some cell or operation processes with potential biological hazards, the isolator can prevent the leakage of harmful substances and protect the health and safety of operators.
Controlling the Operating Environment: It can accurately control and adjust the parameters such as temperature, humidity and gas concentration in the working area, providing suitable environmental conditions for cell growth and preparation and ensuring the viability and function of cells.
Maintenance and Care
Regular Cleaning: Regularly clean the inside and outside of the isolator to remove dust, stains and microbial residues on the surface. Use appropriate disinfectants and cleaning tools during cleaning to avoid damaging the equipment.
Air Filter Replacement: Replace the air filter regularly according to the frequency of use and environmental conditions to ensure the filtering effect. Generally, the service life of the HEPA filter is about 1-2 years.
Equipment Inspection and Calibration: Regularly inspect and calibrate the various parameters of the equipment, such as the accuracy of sensors such as temperature, humidity and pressure, and the stability of gas flow. Timely repair and adjust any problems found to ensure the normal operation of the equipment.
Technical Data
MOC |
316 stainless steel wire drawing board |
Sealing |
The leakage rate of the cabin is less than 5% within 10min under the pressure of 500Pa |
Wind speed |
0.35~0.65m/s, adjustable wind speed, keep 20~60Pa during aseptic operation, maintain the pressure under static conditions to a set value of not less than 10Pa |
Automatic removal efficiency |
<1PPM, 10~20min |
Cleanliness Degree |
Class A |
Power source |
AC220V±22V, 50Hz±1Hz |
Size |
Standard inner compartment 1800*710*850 Standard outer dimensions: 1900*800*2200, can be customized according to requirements |
Verification content |
Sterilization efficiency: biological indicator, chemical test |