1. Determine the cleanliness level and applicable standards
Choose the cleanliness level based on production needs: According to the control requirements of the production process for particles and microorganisms, refer to the ISO 14644 standard to determine the cleanliness level. For example, ISO Class 5 (Class 100) is suitable for high-precision pharmaceutical or biotechnology production, while ISO Class 7 (Class 10,000) may be used for medical device assembly.
FDA-related regulations: FDA requires clean rooms to comply with GMP (Good Manufacturing Practice), focusing on controlling microbial contamination, pressure difference, ventilation frequency, etc. For example, FDA stipulates that the pressure difference between adjacent clean areas must be at least 12.5 Pascals (Pa) to prevent cross-contamination.
2. Building materials and structural design
Material property requirements:
Smooth and dust-free surface: Melamine resin, color steel plate and other materials are preferred to avoid adsorption of particles and are easy to clean.
Anti-static and flame retardant: The material must have anti-static properties to reduce dust adsorption and meet fire protection standards (such as Class A flame retardant).
Airtight design: doors, windows and partitions need to be well sealed to prevent external pollutants from penetrating. For example, the automatic lifting seal strip at the bottom of the door can enhance airtightness.
Floor and wall: Epoxy self-leveling or PVC roll floor is recommended, which is seamlessly connected to the wall; the wall panels need to be sealed on all four sides to prevent the sandwich material from leaking out.
3. Pressure difference and airflow control
Positive and negative pressure design:
Positive pressure area: The core clean area needs to maintain positive pressure (such as ≥12.5 Pa) to prevent pollutants from non-clean areas from entering.
Negative pressure area: Areas involving harmful substances (such as pathogens) need to maintain negative pressure to prevent internal pollutants from leaking out.
Dynamic and static pressure difference management:
Dynamic pressure difference: The pressure gradient inside and outside the clean room is maintained through the ventilation system to ensure reasonable air flow.
Static pressure difference: There must be a pressure gradient between areas of different clean levels, such as a step-by-step decrease from a high clean area to a low clean area.
4. Air filtration and sterilization system
High efficiency filter (HEPA/ULPA): A liquid tank sealed high efficiency filter must be used, and PAO (aerosol) test must be passed to ensure zero leakage. Class A clean areas require unidirectional flow (laminar flow) and uniform wind speed (0.45 m/s±20%).
Air change frequency and self-cleaning capacity: The air change frequency is adjusted according to the cleanliness level. For example, the air change frequency of ISO 5 cleanrooms must be much higher than that of ISO 8. After production, it takes 15-20 minutes to self-clean to reach the static standard.
Disinfection measures: Use fast-evaporating cleaning agents such as isopropyl alcohol (IPA) combined with ultraviolet or ozone sterilization systems to control microorganisms.
5. Compliance verification and continuous maintenance
Documents and certifications: Material suppliers must provide ISO 9001 or ISO 13485 certification to ensure compliance with FDA and GMP standards.
Regular testing: Pressure differential monitoring, particle counting, microbial sampling and filter integrity testing are required, and data must be recorded for review.
Personnel training and process management: Establish strict dressing procedures (such as wearing anti-static clothing), material entry and exit procedures, and conduct regular audits to maintain compliance.
Example application scenarios
Pharmaceutical industry: Focus on microbial control, use Class A laminar flow hoods and negative pressure weighing equipment to ensure aseptic operation.
Electronic manufacturing: Focus on anti-static materials and particle control, and use low-dust materials such as aluminum honeycomb panels
Media ContactCompany Name: Kunshan Dersion Environmental Technology Co., Ltd.Email: Send EmailCountry: ChinaWebsite: https://www.dersionclean.com/
