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Full-Process Construction of SPF Animal Facility Barrier Environments: Key Points from Planning and Construction to Acceptance

Created on 01.29
Abstract:
This article systematically explains the three critical stages in the construction of SPF animal facility barrier environments: pre-planning, construction, and acceptance. The focus of the planning stage is functional layout and regulatory compliance; the construction stage centers on compliant implementation of enclosure structures, MEP systems, and key equipment; and the acceptance stage requires authoritative testing and validation. Mastery of the full process is the foundation for ensuring long-term stable operation, safeguarding animal quality, and maintaining the validity of experimental results.
Metal rack with rows of amber containers in an industrial setting.

I. Introduction: The Severe Consequences of Barrier Environment Failure

The SPF (Specific Pathogen Free) animal facility barrier environment is a highly controlled, enclosed system whose core function is to prevent the intrusion of external pathogens and to control the spread of internal contamination. Any deficiency in planning, defect in construction, or inadequacy in acceptance can directly lead to barrier failure, potentially triggering disease outbreaks in animal colonies, distortion of experimental data, interruption of research projects, and even significant economic losses. Therefore, treating SPF animal facility construction as a system engineering project and implementing full-process control is a fundamental requirement.

II. Stage One: Scientific Planning — Laying the Foundation for Success

Planning determines the project’s direction and upper limits. This stage must address the following key issues:

1. Requirement Analysis and Standard Definition

  • Clearly define animal species, strains, scale, and experimental types, and determine specific parameters such as cleanliness grade (e.g., Grade 7 as required by GB 14925), pressure differentials, temperature and humidity, illumination, and noise levels.
  • Comply with core regulations and standards, including
Laboratory Animal — Environment and Facilities (GB 14925), Code for Design of Clean Plant (GB 50073), and Code for Design of Biosafety Laboratory Buildings (GB 50346).

2. Process Flow and Floor Plan Layout

  • Design unidirectional flows:
Strictly implement the principle of separating the four flows—personnel, animals, materials, and waste—to avoid cross-contamination. A dual-corridor layout (clean corridor – animal room – dirty corridor) is commonly adopted.
  • Define functional zones:
Including clean areas (changing rooms, air showers, clean material storage), core areas (animal rooms, experimental operation rooms), waste handling areas (washing and disinfection rooms, temporary waste storage), and auxiliary areas (mechanical rooms, air-handling units).
  • Establish pressure gradients:
Ensure airflow moves directionally from clean areas → core areas → contaminated areas. The minimum static pressure differential between adjacent areas should be ≥10 Pa.
Industrial rack with multiple brown containers and blue handles in a warehouse setting.

III. Stage Two: Precision Construction — Turning Design into Reality

Construction translates drawings into physical facilities, with quality control as the core focus.

1. Enclosure Structure Construction

  • Material selection:
Walls and ceilings should use color steel panels with good airtightness, corrosion resistance, and ease of cleaning and disinfection (e.g., magnesium oxide or rock wool cores). Floors should use epoxy self-leveling systems or PVC sheet flooring to ensure seamlessness, wear resistance, and chemical resistance.
  • Airtight construction:
All joints and wall penetrations must be reliably sealed. This is the physical basis for maintaining pressure differentials and cleanliness levels.

2. MEP System Installation

  • HVAC purification system:
The “lungs” of the barrier environment, which must achieve:
Real-time monitoring and recording of key parameters such as pressure differentials, temperature, humidity, and cleanliness, with alarm functions for abnormal conditions.

3. Integration of Key Equipment

  • Pass boxes/chambers:
Must be equipped with interlocking mechanisms and sterilization functions (e.g., ultraviolet or vaporized hydrogen peroxide).
  • Water supply and bedding treatment systems:
Drinking water must be sterilized; bedding and cages must pass through double-door autoclaves for sterilization before entering the barrier area.

IV. Stage Three: Strict Acceptance — The Gateway to Compliant Operation

Acceptance is the final step in verifying compliance through objective testing.

1. Third-Party Testing and Validation

  • Independent third-party testing agencies with CMA/CNAS accreditation must be engaged.
  • At-rest/static testing:
Conducted after facility completion, with systems operating but without animals present.

2. Core Validation Items

  • Cleanliness testing:
Particle concentration testing for ≥0.5 μm and ≥5 μm particles using particle counters.
  • Pressure differential testing:
Verification that pressure gradients between all adjacent areas meet design requirements (≥10 Pa).
  • Airflow direction and velocity testing:
Visual verification of airflow direction using smoke generators, and uniformity testing of supply air velocity using anemometers.
  • HEPA filter integrity testing:
Scanning leak tests using PAO or DOP methods to ensure zero leakage.
  • Comprehensive parameter testing:
Including temperature, humidity, illumination, noise level, ammonia concentration, and other relevant indicators.

3. Documentation Handover and Training

  • Receipt of complete as-built drawings, equipment operation manuals, maintenance guides, and third-party validation reports.
  • Systematic training for facility managers and operators to ensure understanding of operating principles and standard operating procedures (SOPs).

V. Conclusion: Systematic Thinking Throughout the Entire Process

The construction of an SPF animal facility barrier environment is a complex and highly specialized engineering task. Planning, construction, and acceptance are interdependent stages that must not be treated in isolation. Successful implementation depends not only on selecting high-quality materials and equipment, but also on adopting an end-to-end systematic mindset and refined full-process management. Only by strictly controlling the key points at every stage can a safe, reliable, and compliant SPF animal research platform be established, providing solid support for life science research.
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