Construction and Management of SPF-Grade Animal Laboratories
Since the 21st century, rapid advancements in the fields of medicine and life sciences have emerged as focal points of global competition. As vital subjects in these areas, laboratory animals have gained significant attention, with the development of laboratory animal science often serving as a benchmark for the level of life sciences and medical research.
Globally, including in China, laws and regulations mandate the safety and efficacy evaluation of biological products, pharmaceuticals, cosmetics, and other products, primarily through animal testing. The quality of laboratory animals is directly related to the accuracy and scientific validity of experimental data. The quality of animals is closely linked to their source, the facilities in which they are housed, and the management practices in place. Among various levels of laboratory animals, Specific Pathogen-Free (SPF) animals are recognized as standard in life sciences and medical research. According to the "Regulations on the Administration of Laboratory Animals" in China and the national standards for laboratory animals and facilities, an SPF-grade animal laboratory has been constructed within the university's animal center. After passing inspection and receiving an "Animal Use License," the laboratory is now operational, housing and managing laboratory animals and conducting related research projects.
1. Construction of the SPF-Grade Animal Laboratory at the Animal Center
(1) Architectural Features:
The SPF-grade animal laboratory covers an area of 300 m², with an indoor ceiling height of 2.4 meters. The walls and ceilings are made of lightweight, purifying colored steel plates, with specialized purification inner arcs and outer vertical columns. The floors are coated with 2.5 mm thick MS epoxy resin self-leveling clean coating. The doors are equipped with specialized airtight purification doors with observation windows. The one-way corridor is designed in a clockwise direction. The barrier system includes two rat rooms, one mouse room, two isolation observation rooms, three experimental preparation rooms, three functional laboratories, one clean storage room, and one cleaning and disinfection room. Additionally, there are monitoring rooms, machine rooms, and power distribution rooms outside the barrier system.
(2) Design Parameters:
- Temperature: 20-26°C
- Daily temperature fluctuation: ≤4°C
- Relative humidity: 40%-70%
- Air changes: 15-20 times/hour
- Airflow velocity: ≤0.2 m/s
- Pressure gradient: 20-50 Pa
- Air cleanliness: Class 7
- Colony count: ≤3 CFU/dish
- Ammonia concentration: ≤14 mg/m³
- Noise: ≤60 dB
- Minimum working illuminance: ≥200 lx
- Animal illuminance: 15-20 lx
- Light-dark cycle: 12/12 hours
(3) Ventilation and Air Conditioning Systems:
The laboratory uses a full fresh air central air conditioning and ventilation system. Air passes through primary, intermediate, and high-efficiency filters before entering the laboratory environment. The air conditioning equipment is located between the primary and intermediate filters and consists of a unit with two compressors, one for use and one for backup, ensuring the system operates normally. The air supply outlet is located 0.25 meters from the ground on the compression unit side.
(4) Lighting System:
Manual and automatic switches are installed in various areas, such as the first and second changing rooms, shower rooms, airlocks, clean corridors, clean storage areas, dirty corridors, buffer rooms, cleaning and disinfection rooms, animal housing rooms, preparation rooms, isolation observation rooms, and functional laboratories. Lighting can be adjusted as needed. Daylight fluorescent lights are turned on and off at 7 AM and 7 PM, respectively. Animal rooms are equipped with animal lighting to regulate the animals' sleep cycles. Unused rooms, clean corridors, clean storage areas, dirty corridors, etc., are subjected to UV light irradiation at 12 PM and 8 PM for 1 hour daily.
(5) Communication System:
Due to the special environmental and facility requirements of SPF-grade animal laboratories, personnel cannot freely enter and exit once inside. However, communication between indoor and outdoor areas is crucial. Therefore, all rooms are equipped with internal telephones, arranged in sequence, allowing for inter-room communication and direct contact with the monitoring room to ensure timely communication within the laboratory.
(6) Monitoring System:
Cameras capable of 270° rotation are installed at key locations such as entrances, corridors, animal housing rooms, and functional operation rooms in the SPF-grade animal laboratory. This allows for real-time monitoring of facility operation status, ensuring adherence to scientific procedures, preventing contamination caused by human factors, and observing animal status and reactions during experiments with minimal disturbance.
(7) Water Supply System:
SPF-grade laboratory animals should ideally be provided with purified water. In this laboratory, a pipeline system delivers treated purified water to the preparation rooms within the barrier system, where water troughs are installed to supply sterilized drinking water and other water needs. The water supply pipes must be regularly replaced and cleaned, and cage cleaning water should include a suitable proportion of 84 disinfectants.
(8) Power Supply, Alarm System, and Fire Safety Facilities:
SPF-grade animal laboratories require continuous air and power supply. Any failure to promptly identify and address faults could lead to environmental contamination, animal infection, or death, with severe consequences. Therefore, a separate and stable power supply system with emergency power backup should be in place. A fan fault alarm system is installed in the central air conditioning control room for timely maintenance, ensuring the safe operation of the facilities.
In compliance with the "Fire Protection Law of the People's Republic of China," fire safety facilities are installed at various locations within the animal center, with regular inspections, maintenance, and replacements to prevent potential hazards.
(9) Disinfection and Sterilization Equipment:
To prevent contamination from external items entering the SPF-grade animal laboratory, disinfection methods are selected based on the characteristics of the items, including UV irradiation, trough disinfectant, or specialized motorized door vacuum sterilizers.
(10) Animal Housing Cages:
Two main types of cages are used for housing rats and mice:
- Stainless steel cages:
- Polycarbonate plastic cages:
The standard stainless steel cages are 40 cm (L) x 30 cm (W) x 20 cm (H), suitable for housing specialized experimental animals individually, with trays and feeding troughs to ensure ample food and activity space while maintaining indoor cleanliness. Standard plastic cages are 45 cm (L) x 35 cm (W) x 20 cm (H) and are suitable for housing 5-7 rats weighing up to 270 g or 50-70 mice, ensuring adequate space for activity.
Both types of cages are paired with stainless steel cage racks.
(11) Bedding Material Selection and Usage:
Bedding material directly contacts the rats and mice, providing moisture absorption, warmth, and nesting. The quality of bedding directly affects post-surgical recovery, growth, development, and reproductive performance. Common bedding materials include corn stalks, shavings, and tissue paper. Tests have shown that 3-5 cm long, dust-screened corn stalks are the most beneficial for growth, development, and reproduction.
(12) Feed Formulation:
The production and maintenance feeds for rats and mice must be scientifically formulated according to national standards. Microbial and nutritional content tests are conducted every six months to ensure feed quality.
2. Operation and Management of the SPF-Grade Animal Laboratory
2.1 Strict and Effective Scientific Management
The SPF-grade animal laboratory's planning, construction, equipment, commissioning, and monitoring are completed under the guidance of the Hubei Provincial Science and Technology Department expert group. The laboratory proactively applies for annual inspections and guidance from the Hubei Provincial Science and Technology Department when the "Animal Use License" expires to identify and address problems and hidden dangers. Additionally, equipment and indoor and outdoor environments are inspected every three months. Alongside strengthening hardware construction and management, a series of regulations have been established to ensure the effective operation of the SPF-grade animal laboratory, fully complying with national standards.
2.2 Development of Regulations and Management Measures
To ensure the SPF-grade animal laboratory operates under compliant conditions, a series of scientifically effective regulations and management measures have been developed based on actual conditions, following relevant national standards. These regulations and measures include:
- Guidelines and management procedures for entering and exiting the SPF-grade animal laboratory
- Sterilization and cleaning management standards for the internal and external environment of the SPF-grade animal laboratory
- Guidelines for feeding and managing animals in the SPF-grade animal laboratory
- Record-keeping regulations for the SPF-grade animal laboratory
- Guidelines for handling animal carcasses and other experimental waste in the SPF-grade animal laboratory
- Feed management regulations for the SPF-grade animal laboratory
- Animal welfare and biosecurity regulations
- Equipment operation, usage, and maintenance regulations
- Procedures for introducing items into the SPF-grade animal laboratory
- Procedures for personnel entry into the SPF-grade animal laboratory
- Procedures for animal entry into the SPF-grade animal laboratory
2.3 Strict Regulations on Personnel, Animal, and Item Movement
Personnel, animals, and items entering and exiting the SPF-grade animal laboratory must strictly follow a one-way clockwise movement principle:
- Personnel movement route:
- Animal movement route:
- Item movement route: