GMP biological laboratory supporting equipment
GMP biolabs typically employ a two-level barrier. The isolation between operators and operating objects in GMP biosafety laboratories is a major barrier, mainly including biological safety cabinets at all levels, animal isolators and personal protective equipment. Biological Safety Cabinets, Isolators, IVCs, Dissection Tables and...
Text label: GMP biological pharma machinery, biological laboratory equipment
GMP biological laboratory supporting equipment
GMP biolabs typically employ a two-level barrier. The isolation between operators and operating objects in GMP biosafety laboratories is a major barrier, mainly including biological safety cabinets at all levels, animal isolators and personal protective equipment. The operation of biological safety cabinets, isolators, IVCs, dissection tables and other equipment often associated with laboratory systems is a critical safety barrier.
1. Biological safety cabinet
Biosafety Cabinets (BSCs) are designed to protect operators, laboratory environments and experimental materials from infectious aerosols and splashes that may cultures, bacterial strains, and diagnostic samples) during manipulation. Aerosols can be generated when a liquid or semi-fluid is manipulated, such as by shaking, pouring, stirring, or dripping a liquid onto a solid surface or another liquid. Infectious aerosols may be generated during these GMP biolab operations, such as streak inoculation of agar plates, inoculation of cell culture flasks with straw, etc. Because aerosols smaller than 5 μM in diameter and tiny droplets 5–100 μM in diameter cannot be seen by the naked eye, GMP biolab workers are often unaware that particles of this size are produced and may inhale or contaminate other materials on the bench. Studies have shown that the correct use of biological safety cabinets can effectively reduce laboratory infections caused by aerosol exposure, and biological safety cabinets can also protect the environment.
2. Animal equipment
Animal Isolator or Negative Pressure Isolation Ventilation Cage: In the biosafety pharma machinery of level 2 and above, small animals must be kept in animal isolator or negative pressure independent ventilation cage. The exhaust from the isolator is filtered by HEPA. emission.
a.
Negative pressure cage changer: used to change cages when raising small animals. There is negative pressure in the cage changing cabinet, and the exhaust is discharged after HEPA filtration.
b.
Negative pressure dissection table: The air pressure in the negative pressure dissection table cabinet should be negative pressure, and there should be a certain direction of airflow. The drainage pipe of the negative pressure dissection table should reserve a drainage interface or install a waste water collection container.
3. Biosafety double door autoclave
The double-door autoclave is used for the transfer of goods from the protection area to the auxiliary work area, which has a reliable sterilization effect on the surface and interior of the goods,
The two airtight doors of the double-door autoclave in the third-level biosafety laboratory should be opened in the protection area and the auxiliary work area, respectively, and the double-door autoclave in the fourth-level biosafety laboratory has two airtight doors Open in core GMP laboratory and protection area respectively. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of biological laboratories and sterile rooms and other supporting services.
4. Life support system and positive pressure protective clothing
With the development of biotechnology, the emergence of many new microbial detection equipment, the popularization of genetic engineering technology, and the development of molecular biology theory, the research on pathogens has reached the molecular level, and large-scale cutting-edge equipment is more and more common. Moreover, in order to identify pathogens and test the efficacy of vaccines, animal models must be established. These tasks generally need to be carried out in a large working space and in an open state. Experimenters must wear individual protective positive pressure suits to ensure their own safety. This method provides researchers with more free movement space for pathogen research, and it is more convenient to operate various new equipment and instruments, which can further improve work efficiency.
Due to the advancement of science and technology, the reliability of the positive pressure suit and air supply system has been improved, the laboratory sealing technology and control technology have matured, and the biosafety laboratory has been gradually adopted because of its convenience, flexibility, safety and reliability. Most of the newly built GMP biosafety level 4 laboratories in the world use positive pressure suit biosafety laboratories.
Life support system is a special equipment to provide breathing air source for the staff of the core GMP biological pharma machinery, mainly including compressed air preparation, filtration treatment, gas analysis, refrigeration, heating and safety alarms. The concentration of carbon monoxide in the provided gas source is less than 10 ppm, the concentration of carbon dioxide is less than 150 ppm, and the temperature, humidity, pressure and gas flow rate of the gas supply source are controllable. Breathing air is sent to each laboratory by stainless steel pipes, which can be connected to positive pressure suits through flexible pipes as needed. The positive pressure suit consists of double-sided PVC fabric, and the air supply is controlled by a rotatable valve. Air is supplied to the arms, legs and face through the air supply pipes in the protective clothing.
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