1. Laboratory planning and design
(1) Functional zoning
① Clean area: used for cell culture and aseptic operation, designed according to the clean level (such as Class 10,000, Class 100), equipped with air shower room, transfer window and other buffer facilities to maintain a sterile environment.
② Preparation area: responsible for culture medium preparation, reagent preparation, consumables sterilization and other work, equipped with ultra-clean workbench, sterilizer, refrigerator and other equipment.
③ Detection and analysis area: for cell morphology observation, vitality detection, molecular biology analysis and other experiments, requiring the placement of microscopes, flow cytometers, PCR instruments and other precision instruments.
④ Waste treatment area: dedicated to the treatment of waste generated by the experiment, equipped with high-pressure sterilizers, special garbage cans, etc. to prevent the spread of biological contamination.
(2) Environmental control
① Temperature and humidity control: install a constant temperature and humidity air conditioning system to control the temperature at 20-26℃ and the humidity at 40%-60% to ensure the stable operation of cells and experimental instruments.
② Ventilation and gas supply: Set up fume hoods and ventilation systems to promptly exhaust harmful gases, equip with nitrogen, carbon dioxide and other gas supply devices to meet the needs of cell culture and experiments.
2. Equipment and consumables configuration
(1) Core equipment
① Cell culture equipment: including carbon dioxide incubators, biosafety cabinets, and clean benches to ensure a sterile environment and personnel safety during the cell culture process.
② Microscopic observation equipment: inverted microscopes and fluorescence microscopes for observing cell morphology, structure, and specific markers.
③ Storage equipment: ultra-low temperature refrigerators (-80°C) and liquid nitrogen tanks for long-term storage of cell lines, samples, and reagents.
(2) Auxiliary equipment
① Sterilization equipment: high-pressure steam sterilizers and dry heat sterilizers for sterilizing experimental equipment and waste.
② Liquid handling equipment: pipettes and centrifuges for precise liquid operations and sample separation.
(3) Consumables: prepare disposable consumables such as sterile culture dishes, culture bottles, pipettes, and cryopreservation tubes to reduce the risk of cross contamination.
3. Safety Management System
(1) Biosafety Protection
① According to the level of biohazard involved in the experiment, equipped with biosafety cabinets of corresponding levels, operators must wear protective clothing, masks, gloves and other protective equipment.
② Formulate strict biosafety operation specifications, classify and treat experimental waste, and dispose of it as medical waste after high-pressure sterilization.
(2) Chemical Safety: Inflammable, explosive and toxic chemicals are managed by designated personnel and stored in dedicated counters, equipped with fume hoods and emergency eyewash stations, fire extinguishers and other safety facilities.
(3) Personnel Training: Regularly organize laboratory personnel to participate in biosafety and equipment operation training, and they can only take up their posts after passing the assessment.
4. Quality Control Plan
(1) Standardized Operating Procedure (SOP): Develop SOP documents covering the entire process of cell culture, detection and analysis, equipment maintenance, etc. to ensure the standardization and consistency of experimental operations.
(2) Experimental Records and Traceability: Require experimental personnel to record the experimental process, data and results in detail to facilitate data traceability and quality analysis.
(3) Regular calibration and verification: Regularly calibrate and verify the performance of instruments and equipment, such as the temperature and carbon dioxide concentration calibration of the incubator, to ensure the accuracy of experimental data.
(4) Internal and external quality control: Conduct internal quality control, such as parallel experiments and negative and positive controls, participate in external quality assessment activities, compare with other laboratories, and improve the quality of testing.
5. Information management system
(1) Laboratory Information Management System (LIMS): Realize the digital management of information such as samples, experimental data, instruments and equipment, and personnel to improve work efficiency and data security.
(2) Electronic records and data storage: Use electronic documents to record experimental data and back them up regularly to ensure long-term preservation and retrieval of data.