Laboratory animals and animal test management regulations 1. General
1. To ensure the quality of the production, verification and scientific research of biological products, it is necessary to strengthen the scientific management of laboratory animals and animal experiments.
2. The experimental animals referred to in this regulation refer to animals with clear origin or clear genetic background that meet the requirements of microbiological control indicators and are used for the production, verification and scientific research of biological products.
3. This regulation includes two parts: experimental animal production and animal experiment. Implement the national certification system for laboratory animals. The experimental animal department of each unit shall formulate the corresponding implementation rules for implementation in accordance with this regulation and specific conditions.
2. Laboratory animal facilities
1. Site selection: It should meet the national and local requirements for buildings. In addition, it should be fully considered from the perspective of laboratory animal health and epidemic prevention. There are no breeding grounds for livestock, poultry, and other animals in the surrounding area, and choose areas that are unlikely to become intermediate hosts for breeding or control of breeding. Try to choose an area free of air pollution and noise interference.
2. Experimental animal facilities are divided into experimental animal production and experimental animal testing. Animal production and animal testing facilities should be strictly separated.
3. Corresponding laboratory animal facilities shall be constructed according to the species, strains and levels of microbiological control of laboratory animals. In order to prevent different kinds of animals from interfering with each other, animals of different strains have genetic pollution, and animals of different levels have microbial contamination.
4. There should be a sufficient number of test animal feeding rooms to facilitate animal testing of different breeds, strains, different microbiological control levels, and different test purposes to be isolated and fed.
5. Animal feeding rooms for infectious and radioactive biohazard tests should be strictly separated from the animal rooms for general tests and have strict safety protection measures to prevent the leakage of biologically hazardous substances and the health of staff Hazards.
6. Construction requirements of the facility
6.1 The general national and local requirements for building design and construction shall be met, but the particularity of laboratory animal facilities shall be fully considered. The surface of the inner wall should be smooth and flat, and the yin and yang angles are round and isolated, which is 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 ground should be non-slip, wear-resistant, and free of leakage, and the design of the launching water is reasonable to ensure the smooth flow of water. The ceiling should be resistant to water and corrosion. The breeding room should have good air tightness. The corridor should have sufficient width, the door width should not be less than 900mm, the supply and exhaust air should be able to be controlled, and meet the requirements of the microbiological control level of the animals raised. There should be two-way power supply and standby power generation equipment to ensure the normal operation of the ventilation equipment.
6.2 There should be a clear area division in the laboratory animal facility.
(1) Animal feeding area: animal production, breeding, feeding observation during the test period.
(2) Animal experiment operation area: Adjacent or close to the animal feeding room, an experiment operation room corresponding to the experiment type is set.
(3) Animal acceptance and quarantine area: newly moved animals for inspection and quarantine.
(4) Area for carrying in and storage of articles: the area for carrying in and storage of consumable articles such as feed and bedding, and cage appliances.
(5) Affairs management area: records and various affairs management, dressing, toilet and bathroom, etc.
(6) Waste disposal area: the temporary storage area before the harmless treatment of garbage and animal carcasses.
(7) Scrubbing, disinfection and sterilization area: washing and disinfection of cages, sterilization and sterilization of feed, bedding and other items.
(8) Machine room area: air-conditioning machine room, power distribution room and other equipment installation areas.
(9) Other areas: corridors, halls, stairs, elevators and other areas.
7. The environmental conditions of the laboratory animal feeding room; the environmental conditions of the breeding room are divided into four categories according to the different requirements for the control of laboratory animal microorganisms.
7.1 Open system: It is suitable for raising common-level laboratory animals.
7.2 Sub-barrier system: suitable for feeding clean-grade laboratory animals.
7.3 Barrier system: It is suitable for feeding SPF-free laboratory animals.
7.4 Isolation system: suitable for feeding SPF and aseptic (GF) grade laboratory animals.
8. Standards for environmental conditions of laboratory animals: according to Table 1 of "Standards for Environmental and Facilities of Medical Laboratory Animals" of the Ministry of Health.
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