GB 27421-2015Mobile laboratories - General requirements for biosafety (English PDF)

6.2 Basic requirements

6.2.1 It shall be easy to reach or to be transported to the designated place.

6.2.2 The parts to be transported shall have suitable loading and unloading, handling and fixing devices to meet the requirements of handling and transportation tools. Lifting devices and supporting wheels should be provided to achieve short-distance movement.

6.2.3 The maximum overall dimensions of the laboratory and removable parts should be designed and manufactured with reference to the relevant national standards for removable facilities.

6.2.4 Design and model selection shall be carried out according to the principles and requirements of modularization, integration and standardization, so as to ensure universality and ease of maintenance.

6.2.5 If applicable, maintenance-free equipment shall be selected.

6.2.6 The layout of facilities and equipment, the working space, and the equipment operating mode shall be reasonable, so as to ensure smooth work flow and comply with the principles and requirements of ergonomics.

6.2.7 The implementability of all maintenance works shall be ensured, and the work station space shall be suitable for the needs of human body measurement, posture and use of tools. Mechanical and electrical equipment, if installed, shall not affect the maintenance work.

j) sand and dust;

k) smog (including salt fog);

l) pests (such as fungi, arthropods, rodents).

6.2.16 Documents such as schematic diagrams, operation instructions, maintenance manuals and safety manuals that meet the needs of on-site use, maintenance and repair shall be provided.

6.2.17 The self-propelled laboratory shall be provided with relevant documents of the motorized driving part, which shall meet the requirements of 6.2.16.

6.2.18 When applicable, documents such as good manufacturing practices for mobile laboratories and on-site emergency response plans shall be provided.

7.1 BSL-1 laboratory

7.1.1 The laboratory may consist of a single laboratory room. The primary barrier mode can be open, but it shall be based on risk assessment, including the content of experimental quality control requirements.

7.1.2 The fixed equipment, table cabinets and wall cabinets of the laboratory shall be firm and connected with the cabin reliably, and the connection shall be smooth and easy to clean.

7.1.3 When the laboratory is moved, there shall be reliable mechanisms and measures to fix items such as instruments and equipment, experimental equipment and seats.

7.1.4 The height of the laboratory shall meet the requirements for equipment installation, and there shall be space for maintenance and cleaning.

7.1.5 The laboratory shall be ventilated. If natural ventilation is used, openable windows and/or ventilation fans may be provided, and the air inlets of openable windows and/or ventilation fans shall be installed with screens that can prevent mosquitoes.

7.1.6 If mechanical ventilation is used, an air-conditioning system with circulating air may be used. The laboratory air-conditioning system shall be reasonably designed according to the area and climatic conditions where the laboratory is used.

7.1.7 A municipal water supply interface should be reserved for the laboratory, and a sewer collection device can be set up. The effluent discharge, if any, shall be based on risk assessment.

7.1.8 In the case of handling irritating or corrosive substances, an eyewash device or an eyewash bottle shall be provided in the laboratory. If a large amount of irritating or corrosive substances are used, an emergency spraying device shall be set up.

7.1.9 UV disinfection lamps and portable disinfection and sterilization devices (such as disinfection sprayers) shall be installed in the laboratory.

7.1.10 When necessary, it shall be equipped with high pressure steam sterilizer or other appropriate disinfection and sterilization equipment.

7.1.11 The average illuminance of the laboratory working area shall not be less than 300 lx.

7.1.12 There shall be a mechanism to maintain smooth communication.

7.2.1 Where applicable, the requirements of

7.1 shall be met.

7.2.2 A buffer room shall be set up at the entrance of the core laboratory room, and the buffer room can also be used as a dressing room for protective clothing.

7.2.3 The doors of the buffer room should be interlocked. If an interlocking door is used, an emergency manual release interlocking switch shall be set near the interlocking door, and, when necessary, the interlocking of the laboratory door shall be released immediately.

7.2.4 During the experiment, the conspicuous position at the entrance of the core laboratory room shall have internationally accepted biohazard warning signs and related information.

7.2.5 The laboratory can adopt natural ventilation or negative pressure ventilation. If a negative pressure ventilation air conditioning system is used, it shall comply with the principle of directional airflow.

7.2.6 The fresh air vents and exhaust vents of the negative pressure ventilation air conditioning system shall be designed to prevent wind, rain, rodents and insects, and the specifications of the air filters shall be determined according to the results of the risk assessment. The fresh air vent shall be

2.5 m higher than the outdoor ground (removable structure can be used); the new air vent shall be set as far away as possible from the exhaust vent.

7.2.7 The core laboratory room shall be equipped with biosafety cabinets or other biosafety isolation devices.

7.2.8 If the exhaust air from biosafety cabinets or other biosafety isolation devices circulates indoors, the laboratory shall be equipped with ventilation conditions.

7.3.8 A non-manual hand washing device or an automatic hand sanitizing device shall be installed near the exit of the core working area of the laboratory.

7.3.9 The core working room of the laboratory should be equipped with a collection and inactivation device for activated toxic wastewater.

7.3.10 The exhaust high-efficiency air filter (or HEPA filter) in the core working room of the level 2 biosafety cabinet laboratory shall have the conditions for in-situ disinfection and leak detection.

7.3.11 The design of the air-conditioning system shall consider the adaptability of the natural environment conditions in the region of use and the heat and humidity load of various equipment; the design of the air supply and exhaust system shall consider the air supply and exhaust of ventilation equipment such as biosafety cabinets and biological isolators.

7.3.12 The air vents, doors, and equipment shall be reasonably arranged to avoid interference and reduce eddy currents and dead ends of airflow in the room.

7.4.1 Where applicable, the requirements of

7.1 shall be met.

7.4.2 The animal feeding room shall be entered through the buffer room or double-door.

7.4.3 Test animal rearing cages shall be set up, and, in addition to safety requirements, the requirements for animal quality and welfare shall also be considered.

7.4.4 The air exhausted from animal rearing cages shall be discharged outdoors through pipes.

7.4.5 Where applicable, the environment and facility conditions of the animal rearing cage shall meet the relevant requirements of GB 14925-2010.

7.5.1 Where applicable, the requirements of

7.4 shall be met. and management of the laboratory at the corresponding level, and their personal qualities and abilities shall be competent for on-site work requirements.

8.5 The person in charge of on-site work shall be responsible for formulating and submitting activity plans, risk assessment reports, safety and emergency measures, personnel training and health supervision plans, technical support plans, security assurance and resource requirements, mobile applications, etc. to the laboratory or higher management.

8.6 Site work procedures, safety manuals and security regulations including moving processes shall be developed and maintained.

8.7 When necessary, an isolation belt shall be set up at the mobile laboratory work site.

8.8 The person in charge of on-site work shall be responsible for completing the summary report of each moving task, submitting it to the laboratory or higher management, and archiving it for preservation.

8.9 The signs at the entrance of the laboratory can be set in a non-fixed way, such as listing.

8.10 Safety inspection shall be carried out before moving the laboratory and before starting work (see Appendix C for some safety inspection guidelines), to ensure:

a) The function and status of the facility and equipment are normal;

b) The function and status of the alarm system are normal;

c) The function and status of the emergency equipment are normal;

d) The function and status of the firefighting equipment are normal;

e) Dangerous goods are safely stored;

f) The number and condition of the waste treatment equipment are normal;

g) The required spare parts (see Appendix D) and guarantee conditions meet the requirements;