ISO 6 Hardwall Cleanroom

Pharmaceutical Manufacturing and Formulation

Pain Point: Airborne particles, uncontrolled personnel movement and unstable pressure relationships may increase contamination risks during formulation, dispensing, sampling and other controlled pharmaceutical operations.

Solution: Deiiang designs ISO 6 hardwall cleanrooms with rigid, sealed and cleanable wall systems, terminal HEPA filtration and configurable pressure cascades. Airlocks, gowning rooms, pass boxes and environmental monitoring can be integrated according to the User Requirements Specification (URS), process risk assessment and applicable quality-system requirements. Final performance is confirmed through the agreed commissioning and testing protocol.

Medical Device Manufacturing and Assembly

Pain Point: Particles, fibers and handling-related contamination can affect the assembly, inspection and packaging of sensitive medical devices and increase quality-control risks.

Solution: The rigid hardwall enclosure provides a stable and cleanable environment for controlled assembly and inspection processes. Wall and ceiling panels, sealed service penetrations, cleanroom doors, pass-through units, personnel flows and material flows can be selected based on the product risk assessment. Monitoring and documentation requirements are defined according to the manufacturing process and applicable regulatory expectations.

Precision Electronics and Optoelectronic Assembly

Pain Point: Airborne particles, temperature variation, excess humidity and electrostatic discharge may affect component cleanliness, product reliability and assembly yield.

Solution: Deiiang can configure ISO 6 hardwall cleanrooms with terminal HEPA filtration, controlled airflow distribution, temperature and humidity management, and optional ESD-control measures. Equipment heat loads, exhaust requirements, workstation locations and process zoning are reviewed during engineering design to support the required operating condition without making unverified universal performance claims.

Optical and Precision Instrument Assembly

Pain Point: Dust deposition, uncontrolled airflow and environmental fluctuations can affect optical surfaces, precision alignment, inspection accuracy and instrument performance.

Solution: The ISO 6 hardwall configuration supports cleanable surfaces, controlled access and stable airflow conditions for optical component handling, precision assembly and inspection. Air distribution, lighting, temperature and humidity limits, low-shedding materials and localized clean zones can be coordinated with the process layout. Vibration control and other specialized requirements should be evaluated separately during the project review.

Clean Assembly, Inspection and Packaging

Pain Point: Open handling, frequent personnel movement and uncontrolled material transfer can introduce particles during final assembly, visual inspection and protective packaging operations.

Solution: Deiiang provides modular ISO 6 hardwall cleanroom layouts with sealed doors, viewing windows, cleanable interior surfaces and defined personnel and material routes. Pass boxes, airlocks, gowning areas and dedicated return-air arrangements can be incorporated where required. The room configuration is developed around the process sequence, occupancy, product sensitivity and cleaning procedures.

Research, Development and Pilot Production

Pain Point: Research and pilot-scale processes often require repeatable environmental conditions, while changing equipment layouts and uncertain future requirements can complicate cleanroom planning.

Solution: The modular ISO 6 hardwall system can be adapted for laboratories, prototype development, process validation and pilot production. Room dimensions, service locations, airflow capacity, monitoring points, equipment access and future expansion provisions are coordinated during the design stage. Particle, airflow, temperature, humidity and differential-pressure testing can be documented according to the agreed project scope.

Project-Specific Engineering and Customization

Requirement: ISO 6 classification defines an airborne-particle cleanliness level under a specified testing condition. It does not by itself confirm sterility, bioburden control, ESD performance, vibration control or suitability for every process.

Customization: Deiiang can tailor room dimensions, rigid sandwich panels, coated-steel or stainless-steel interior finishes, H13/H14 HEPA filtration, airflow patterns, HVAC capacity, cleanroom doors, viewing windows, pass boxes, airlocks, ESD flooring, monitoring systems and PLC/HMI controls. Design decisions are based on the URS, process and contamination-control risk assessment, personnel and material flows, equipment heat load and required operating condition.

Verification: Final classification and system performance should be verified on site in accordance with the agreed test plan and applicable standards, such as particle-count testing, airflow measurement, HEPA filter integrity testing, pressure-difference testing and calibration review. Supporting documents may include commissioning records, test reports, calibration certificates and as-built drawings.