+86 18186671616
Jason@cleanroomequips.com
1 Scope
This standard specifies the technical requirements and test methods for laboratory animal breeding, production and experimental environmental conditions and facilities, and also specifies the requirements for bedding, drinking water and cages.
This standard applies to the environmental conditions and facility design, construction, project acceptance and regular supervision and management of all laboratory animal breeding, production and experimental sites.
2 Referenced standards
The provisions contained in the following standards constitute the provisions of this standard through reference in this standard. When this standard was published, the versions shown were valid. All standards are subject to revision. Parties using this standard should explore the possibility of using the latest versions of the following standards.
GB 3095-1996 Ambient air quality standard
GB 3096-1993 Urban area environmental noise standard
GB 4792-1984 Basic standard for radiation health protection
GB 5794-1985 Drinking water hygiene standard
GB 8978-1996 Comprehensive standard for sewage discharge
GB 50243-1997 Construction and acceptance specification for ventilation and air conditioning engineering
GB 50259-1996 Construction and acceptance specification for electrical lighting equipment for electrical installation engineering
GBJ73-1984 Clean room design specification
GBJ68-1984 Unified standard/standard for building structure design
JGJ-71-1990 Clean room construction and acceptance specification
3 Definitions
This standard adopts the following definitions.
Experimental animals refer to animals that are artificially raised, carry controlled microorganisms, and are selected for scientific research, teaching, production, verification, and other scientific experiments with clear background or source.
Experimental animal breeding and production facilities
Refers to the sum of buildings, equipment, and operation management for experimental animal breeding and production. 3.3 Animal experimental facilities refer to the sum of buildings, equipment, and operation management for experimental animal breeding and testing for the purpose of research, testing, teaching, biological products, and drug production.
4 Environment and facilities
4.1 Site selection
Experimental animal breeding, production, and experimental sites should be selected from natural epidemic sources.
Select areas with good ambient air quality and natural environmental conditions.
It is advisable to stay away from railways, docks, airports, major traffic routes, and factories, storage warehouses, yards, and other areas with serious air pollution, vibration, or noise interference that emit a lot of dust and harmful gases. If it is not possible to stay away from the above areas, it should be arranged downwind of the local minimum frequency wind direction in summer.
Experimental animal breeding, production and experimental facilities should be kept at a distance of more than 50m from the living area.
4.2 Building hygiene requirements
All enclosure materials of animal breeding, production and experimental sites should be non-toxic and non-radioactive.
The surface of the inner wall should be smooth and flat, and the corners should be arc-shaped, easy to clean and disinfect. The wall should be made of materials that are not easy to fall off, corrosion-resistant, non-reflective and impact-resistant. The floor should be non-slip, wear-resistant and leak-proof. The ceiling should be water-resistant and corrosion-resistant.
4.3 Building facility requirements
The doors and windows of the building should have good sealing.
The width of the corridor should not be less than 1.5m, and the width of the door should not be less than 1.0m.
The ventilation and air-conditioning system of animal breeding, production and laboratory should maintain positive pressure operation, and the air flow should be reasonably organized to arrange the position of the air supply and exhaust vents to avoid dead corners, interruption of flow and short circuit.
All kinds of environmental control equipment should be regularly repaired and maintained.
The power load level of animal breeding, production and laboratory should be determined according to the process requirements. Emergency power supply should be available.
Indoor power distribution equipment should be selected that is not easy to accumulate dust and should be concealed. Electrical pipelines should be concealed, and reliable sealing measures should be taken for the pipe openings of electrical pipelines from non-clean areas to clean areas.
5 Classification of environmental conditions and technical index requirements
5.1 Ordinary environment
This environmental facility meets the basic requirements for animal living, cannot completely control infectious factors, and is suitable for raising ordinary experimental animals for teaching purposes.
Barrier environment: This environmental facility is suitable for raising clean experimental animals and SPF specific pathogen free experimental animals. This environment strictly controls the entry and exit of personnel, objects and ambient air.
Isolation environment: This environmental facility uses a non-fluorescent isolation device to preserve sterile or non-externally contaminated animals. The air, feed, water, bedding and equipment in the isolation device are all sterile. The dynamic transfer of animals and materials must pass through a special transfer system, which can not only ensure absolute isolation from the environment, but also meet the requirements of maintaining a consistent internal environment when transporting animals. This environmental facility is suitable for feeding specific pathogen-free (SPF), gnotobiotic and germ-free experimental animals.
5.2 Technical index requirements
The environmental index of experimental animal breeding and production facilities should meet the requirements.
The environmental index of animal experimental facilities should meet the requirements.
6 Process requirements for facility area settings
6.1 Regional layout
a. Front area settings: including offices, maintenance rooms, warehouses, feed rooms, general corridors.
b. Feeding area settings
Breeding and production areas: including isolation and quarantine rooms, buffer rooms, breeding rooms, expansion group breeding rooms, production group breeding rooms, waiting rooms, clean item storage rooms, clean corridors, and waste corridors.
Animal experiment area: including buffer room, experimental feeding room, clean item storage room, clean corridor, and dirty corridor.
Auxiliary area: including warehouse, washing room, waste storage and processing room (equipment), closed experimental animal carcass refrigeration storage room (equipment), mechanical equipment room, shower, and staff lounge.
6.2 Other facilities and equipment
Both the barrier environment and the isolation environment should be equipped with buffer settings at the intersection of pressure changes.
The facilities in the animal experiment area should be set up separately from the breeding system.
The operation of radioactive experiments should refer to GB4792.
Animal experiments with highly infectious, carcinogenic, and highly toxic substances should be carried out in negative pressure isolation facilities or equipment with strict protection. Such facilities (equipment) must have a special transmission system to ensure absolute isolation from the external environment during dynamic transmission, and the exhaust gas and waste must be harmlessly treated. The three protection principles of "people, animals, and environment" should be reflected.
6.3 Facilities and equipment
When setting up equipment in the experimental environment, the performance and indicators of the equipment must be consistent with the requirements of the environmental facilities indicators.
Positive pressure and negative pressure equipment for different experimental requirements must meet the indicators of environmental facilities before obtaining the corresponding certificates.
7 Waste and animal carcass treatment
Waste should be treated harmlessly and should meet the requirements of GB8978:
Animal carcasses should be incinerated immediately, and their emissions should meet the requirements of hospital waste incineration emissions.
8 Cages, bedding, drinking water
8.1 Cages
Cages made of durable materials that are non-toxic, corrosion-resistant, high-temperature resistant, easy to clean, and easy to disinfect and sterilize should be selected.
The minimum area of cages occupied by various animals should meet the corresponding requirements, and the inner and outer corners of the cages should be round and smooth without sharp edges.
8.2 Bedding
Bedding materials should be selected from materials with good moisture absorption, less dust, no odor, no toxicity, and no grease.
Bedding materials must be disinfected and sterilized before use.
8.3 Drinking water
Ordinary experimental animal drinking water should meet the requirements of GB 5749.
Drinking water for experimental animals raised in barrier and isolation environments must be sterilized.
9 Animal transportation
Animal transportation should meet the safety and microbial control level requirements, and animals of different breeds, strains and grades shall not be mixed for transportation.
Animal transportation should be equipped with special vehicles, with dedicated personnel responsible for the table, regular disinfection and cleaning, and the vehicles should be equipped with air-conditioning equipment.
Transport cages must be disinfected and sterilized before they can be recycled.
10 Conduct testing
