Requirements and Specifications for Custom Modular Cleanrooms
2026-03-09
The core content and relevant specifications to be clarified during the customization process are organized in accordance with formal written standards as follows:
I. Preliminary Requirement Definition (Basic Premise for Customization)
It is imperative to clearly and accurately define various core requirements in the early stage, so as to provide a solid foundation for subsequent scheme design and module selection. These requirements mainly cover three core dimensions:
(I) Process and Environmental Parameters
1. Cleanliness Class: Determined in accordance with the ISO 14644-1 standard; common classes include ISO 5 (Class 100) and ISO 7 (Class 10,000). The cleanliness class directly dictates the configuration of air filtration efficiency and air change rate.
2. Temperature and Humidity Control: Conventional requirements specify a temperature fluctuation of ±1℃ and a humidity fluctuation of ±5%RH, which may be adjusted based on industry-specific needs (e.g., 22℃±1℃ and 45%RH±5% are commonly adopted in the electronics and pharmaceutical industries).
3. Pressure Difference Requirement: The clean area shall maintain a positive pressure of 10–30Pa relative to the non-clean area; negative pressure shall be implemented for special processes (such as biosafety and harmful gas treatment).
4. Airflow Organization: Vertical unidirectional flow, horizontal unidirectional flow, or turbulent flow (mixed flow) shall be selected in accordance with process requirements.
5. Air Change Rate: The air change rate shall be consistent with the cleanliness class, typically ranging from 30 to 60 times per hour for ISO 7 class and 240 to 600 times per hour for ISO 5 class.
6. Additional Requirements: Specifications for noise, vibration, anti-static performance, illuminance, fire rating, as well as supporting process requirements (e.g., special gases and pure water) shall be clearly defined.
(II) Space and Building Conditions
1. Site Parameters: The length × width × height of the site, column grid distribution, floor height, floor bearing capacity, and floor load shall be clearly specified to ensure that module installation and equipment placement comply with bearing requirements.
2. Layout Planning: Separate channels for personnel and material flow shall be reasonably designed, and the division of functional areas (e.g., dressing rooms, air showers, buffer rooms, equipment areas, and auxiliary operation areas) shall be clearly defined.
3. Interface Conditions: The site power supply capacity, locations of fresh air and exhaust air interfaces, layout of water supply and drainage pipelines, and specifications of compressed air and process gas interfaces shall be confirmed.
(III) Industry Compliance Standards
Compliance requirements shall be clarified based on the application industry to ensure that the cleanroom meets relevant standards, as detailed below:
1. Pharmaceutical Industry: The cleanroom must comply with the relevant requirements of GMP (Good Manufacturing Practice), FDA (Food and Drug Administration), and WHO (World Health Organization).
2. Electronics Industry: The cleanroom must meet the anti-static and micro-pollution control standards of the semiconductor and display industries.
3. Food and Cosmetics Industry: The cleanroom must adhere to HACCP (Hazard Analysis and Critical Control Points) and relevant requirements for aseptic production.
4. General Requirements: The cleanroom must comply with national and local relevant specifications, including those related to fire protection, environmental protection, and safe production.
II. Core Modules and System Configuration (Main Content of Customization)
Modular cleanrooms adopt a "Lego-style" prefabricated assembly mode, and the core modules and system configuration must be accurately aligned with the preliminary requirements, as specified below:
(I) Enclosure Structure Module (Basic Framework)
1. Wall and Ceiling Panels: Steel baking paint panels, stainless steel panels, or aluminum honeycomb sandwich panels shall be selected, which must possess the characteristics of seamless splicing, easy cleaning, fire resistance, anti-static performance, and corrosion resistance.
2. Door and Window Configuration: Closed clean doors and observation windows shall be adopted, equipped with electronic interlocking and automatic closing devices to ensure air tightness.
3. Floor Treatment: Epoxy self-leveling or PVC anti-static floors shall be laid, matched with arc skirting lines to prevent dust accumulation and facilitate cleaning.
4. Sealing Treatment: All joints shall be sealed using chemical welding or special sealant to ensure the overall air tightness of the cleanroom and prevent the infiltration of external pollutants.
(II) Air Purification and HVAC System (Core Functional System)
1. Core Equipment: FFUs (Fan Filter Units) integrated with HEPA (High Efficiency Particulate Air Filters) or ULPA (Ultra Low Penetration Air Filters) shall be configured for ceiling-distributed air supply. MAUs (Make-up Air Units) and AHUs (Air Handling Units) shall be installed to achieve temperature and humidity adjustment, primary and medium efficiency filtration, and heat recovery functions.
2. Filtration System: A multi-stage filtration configuration shall be adopted, sequentially consisting of a primary filter (G4 level), a medium efficiency filter (F8 level), a high efficiency filter (HEPA, filtration efficiency 99.99%@0.3μm), and an ultra-high efficiency filter (ULPA). The filtration level shall be adjusted based on the cleanliness class.
3. Control Device: Air supply, return air, and exhaust air systems shall be equipped, along with differential pressure sensors and temperature and humidity sensors, to realize the automatic adjustment and stable control of air flow and differential pressure.
(III) Auxiliary Function Modules
2. Material Transfer Module: Pass boxes (equipped with ultraviolet sterilization function) and air locks shall be installed to realize the aseptic and dust-free transfer of materials and prevent cross-contamination.
3. Electrical and Mechanical Interface Module: Water, electricity, gas, and network interfaces shall be reserved and installed, along with clean lights, emergency lighting, and anti-static sockets, to meet the requirements of equipment operation and on-site operations.
4. Monitoring System Module: Particle counters and online monitoring equipment for temperature, humidity, differential pressure, and wind speed shall be installed, together with alarm devices and data recording systems, to realize real-time monitoring and traceability of the clean environment.
III. Standard Customization Process (From Requirement to Delivery)
The customization of a modular cleanroom must comply with strict process specifications to ensure controllable quality and meet all requirements. The specific process is as follows:
1. Requirement Communication and On-site Survey: In-depth communication shall be conducted with the customer to clarify process parameters and compliance requirements; on-site surveys of the site structure and interface conditions shall be carried out to form a survey report.
2. Scheme Design and Quotation: Based on the survey results and requirements, the plane layout, 3D modeling, air flow calculation, and system selection shall be completed, and a detailed design scheme and budget quotation shall be issued.
3. Factory Prefabrication of Modules: The prefabrication, pre-assembly, and preliminary testing of core modules (e.g., wall panels, FFUs, air ducts, and pipelines) shall be completed in the factory to ensure module quality and dimensional accuracy.
4. On-site Rapid Assembly: The prefabricated modules shall be transported to the site for "Lego-style" rapid assembly, and the main structure can usually be installed within 2 to 7 days.
5. System Commissioning and Verification: After the completion of equipment installation, system commissioning shall be conducted, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Indicators such as cleanliness, temperature and humidity, differential pressure, air flow pattern, and air change rate shall be tested to ensure compliance with standards.
6. Acceptance, Delivery and Training: A complete verification report shall be issued, and acceptance shall be organized with the customer. Operation and maintenance training shall be conducted simultaneously, and an after-sales service plan shall be provided.
IV. Key Selection and Notes
1. Material Selection: All materials must meet the requirements of non-dusting, easy cleaning, corrosion resistance, fire resistance, and anti-static performance, and be consistent with industry compliance standards.
2. Filter Management: HEPA or ULPA filters shall be selected based on the cleanliness class; the replacement cycle of filters shall be clarified, and regular leak detection and replacement shall be conducted.
3. Energy-saving Design: The FFU layout shall be optimized, and frequency conversion control and heat recovery technologies shall be adopted to reduce the operational energy consumption of the cleanroom.
4. Maintainability: Maintenance channels and accessible ceilings shall be reserved, and designs featuring easy-to-replace filter elements and easy-to-maintain equipment shall be adopted to reduce long-term maintenance costs.
5. Expandability: Equipment interfaces and space shall be reserved to facilitate the later expansion of the cleanroom, upgrading of the cleanliness class, or adjustment of processes.
V. Delivery List (Customization Completion Standard)
Upon completion of customization, a complete set of deliverables shall be provided to ensure the customer's normal use and maintenance, including the following:
1. Design Documents: A complete set of design drawings, including plane layout drawings, system principle drawings, and 3D model drawings.
2. Equipment and Material Certificates: A list of modules and equipment, material certificates, and product qualification certificates.
3. Verification Reports: IQ/OQ/PQ confirmation reports, cleanliness test reports, and other compliance verification documents.
4. Operation and Maintenance Data: Equipment operation manuals, cleanroom maintenance plans, and spare parts lists.
5. Training and Services: Operation and maintenance training records, an after-sales service plan, and quality assurance commitments.
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