ISO 5 Hardwall Cleanroom

Verified ISO 5 Contamination Control

An ISO 5 Hardwall Cleanroom is engineered to control airborne contamination in critical manufacturing, assembly and research processes. Under ISO 14644-1, the maximum permitted concentration for ISO Class 5 is 3,520 particles/m³ at particle sizes equal to or greater than 0.5 μm. Final classification is confirmed by onsite particle testing under the agreed as-built, at-rest or operational condition.

Unidirectional Airflow Performance

Ceiling-mounted H14 HEPA or ULPA filters deliver high-efficiency filtered air to the controlled area. A properly designed unidirectional airflow pattern moves particles away from critical work zones and toward low-level or designated return-air paths. Typical airflow velocity may range from 0.20 to 0.45 m/s, but the final setpoint is determined by process risk, room layout, equipment heat load and onsite airflow studies.

H14 HEPA and ULPA Filtration

H14 HEPA filters provide a minimum overall efficiency of 99.995% at the most penetrating particle size in accordance with EN 1822. ULPA filtration can be specified when the process requires enhanced particle control. Filter selection, ceiling coverage and airflow capacity are determined through engineering calculations rather than cleanroom classification alone.

Installed filters can be integrity-tested using an approved aerosol challenge method to identify leakage around the filter media, frame, gasket and housing. Filter certificates do not ｒｅｐｌａｃｅ onsite installed-system testing.

Positive Pressure and Airtight Hardwall Construction

The rigid modular enclosure uses smooth, sealed and low-shedding surfaces to reduce uncontrolled air leakage and simplify cleaning. A positive pressure cascade, commonly designed within a project-specific range such as 15–25 Pa relative to adjacent lower-grade spaces, helps limit contaminant ingress when doors are closed.

Actual pressure requirements depend on the facility layout, door operation, exhaust systems, process hazards and applicable regulations. Negative pressure or specialized containment configurations require a separate risk-based design.

Stable Environmental Control

Temperature and relative humidity controls can be customized to support product quality, operator comfort and process repeatability. Sensors may continuously monitor temperature, humidity, differential pressure and airborne particles, with optional alarms, trend recording and PLC/HMI integration.

Environmental tolerances are established from the user requirement specification, process sensitivity, occupancy, local climate and equipment loads. They should not be assumed from the ISO cleanliness class alone.

Applicable Standards and Compliance Basis

Deiiang develops each ISO 5 Hardwall Cleanroom around the customer’s user requirement specification and the standards applicable to the intended process. The project compliance framework may include:

• ISO 14644-1: Classification of air cleanliness by particle concentration.

• ISO 14644-2: Monitoring plan requirements for continued cleanroom performance.

• ISO 14644-3: Test methods for cleanroom performance verification.

• ISO 14644-4: Cleanroom design, construction and start-up guidance.

• EN 1822 or ISO 29463: Classification and testing of high-efficiency air filters.

• Applicable GMP requirements: Evaluated separately for pharmaceutical, biotechnology or sterile-processing applications.

Measurable Testing and Traceable Documentation

Performance can be evaluated using calibrated instruments and an agreed acceptance protocol. Depending on the project scope, commissioning and qualification may include airborne particle counting, installed-filter integrity testing, airflow velocity and uniformity measurement, airflow visualization, room differential-pressure verification, temperature and humidity mapping, recovery testing and enclosure inspection.

Available handover records may include equipment datasheets, filter certificates, instrument calibration certificates, test reports, control descriptions, operation and maintenance manuals and as-built drawings. IQ/OQ documentation support can also be prepared when defined in the project scope.

Transparent Performance Statement

ISO 5 performance cannot be guaranteed by filter grade, airflow rate or equipment selection alone. Room classification depends on the complete installed system, including enclosure integrity, airflow distribution, occupancy, process equipment, operating procedures and maintenance. Compliance claims should therefore be supported by onsite testing, documented acceptance criteria and periodic requalification.