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Jason@cleanroomequips.com
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How to Work With Us
Submit Requirements
Provide your site dimensions, required ISO class, and industry-specific needs (GMP, ESD, etc.) to our experts.
Custom Technical Proposal
Receive a detailed design proposal within 24 hours, including airflow strategies, material lists, and transparent pricing.
Modular Production
We manufacture your modular panels, HVAC units, and FFUs with strict QC to ensure full compliance with ISO 14644 standards.
Global Shipping & Setup
Fast global logistics followed by onsite installation guidance and performance validation to get you operational quickly.
Specifications & Models
Applications & Customization
Semiconductor Wafer Transformation
Airborne particles, unstable airflow, and electrostatic discharge cause defects on wafers, process contamination, and subsequently reduced yield.
Airflow isolation chambers with a configuration of ISO 5 cleanrooms along with ULPA, HEPA, and sealed wall systems that have unidirectional flow are proposed to combat these issues. In addition, customizable controls for temperature, relative humidity, differential pressure, and particle count will be designed based on the wafers’ process and required equipment’s heat load.
Pharmaceutical Aseptic Processing
Compromised sterile products are the result of both viable and non-viable contamination as well as insufficient pressure control and substantiation.
Cleanroom configurations with controlled pressure and terminal filtration of high efficiency in combination with cleanable and sealed hardwall surfaces and environmental monitoring (if needed) will be implemented. Designs will include airlocks, pass boxes, devices for controlled clothing removal, and will be sample in ISO 5 classification and verified GMP.
Critical Medical Device Assembly
Particles and handling contamination will increase the risk of quality control and regulatory compliance for implantable, diagnostic and sensitive medical devices.
An enclosed clean environment with sealed hardwall surfaces will provide a stable cleanroom for the assembly of devices. Based on the product and process risk assessment, wall, workstations, material, personnel, and pass-through systems will be integrated with interlocked monitoring devices, if needed.
Optics and Laser Engineering
Process micro particles, temperature changes, and vibration will affect the quality of the coating and the performance of optics and lasers.
Deiiang can modify airflow distribution, temperature, and humidity control; design low vibration equipment placement and use low-shedding interior materials. The design can use localized unidirectional-flow zones for lens assembly, optical coating inspection and integration of laser systems.
Biotechnology and Precision Research
Pain Point: Contamination of the environment and unstable conditions in the room can affect sensitive samples, analytical procedures, and reproducibility of research.
Solution: The ISO 5 hardwall cleanroom can be built with a controlled environment, steady-state pressure, and sealed service openings along with the option of active real-time monitoring systems for particle tracking, temperature, humidity, and differential-pressure. Benches, biosafety equipment and utilities are located based on the process risk assessment and laboratory workflow.
Project-Specific Customization
Requirement: The impact of process equipment, personnel, room size and sources of contamination on ISO 5 performance determine required operating conditions.
Customization: Deiiang can modify room size, wall panels (stainless steel/coated steel), H14 HEPA/ULPA filters, unidirectional airflow, HVAC, ESD flooring, Air showers, pass boxes, door interlocks and control systems PLC/HMI. The final classification will be subject to confirmation by onsite testing in accordance with ISO 14644-1 at the agreed upon as built, at rest or operational condition.
Performance & Compliance
Verified ISO 5 Contamination Control
An ISO 5 Hardwall Cleanroom is designed to control airborne contamination during critical manufacturing, assembly or research. According to ISO 14644-1, the maximum allowed number of particles in a given volume of air at ISO Class 5 is 3,520 particles/m³ at a minimum of 0.5 micrometers. Final classification is dependent on onsite particle testing done under the agreed upon as-built, at-rest, or operational conditions.
Unidirectional Airflow Performance
High efficiency filtered air is supplied from ceiling mounted H14 HEPA or ULPA filters. Unidirectional airflow pattern is designed to move contaminated air away from critical zones and draw it towards low level or designated return air paths. Typical airflow velocity is in the range of 0.20-0.45 meters per second, however the final velocity is dependent on the process risk, room arrangement, heat load of equipment and onsite airflow studies.
H14 HEPA and ULPA Filtration
H14 HEPA filters as per EN 1822, have an efficiency of 99.995% against the most penetrating particle size. ULPA filtration may be requested to control process requirements for improved particle capture. engineering design and airflow analysis is used to select type and location of filters and the ceiling as opposed to the level of cleanroom classification.
Filter integrity tests may be performed using the approved aerosol challenge method to determine if air leaks from the filter media or frame or housing. Filter certificates do not require on-site tested of the installed system.
Positive Pressure & Airtight Hardwall Construction
The modular hardwall design features low-shedding surfaces to minimize air leakage. Smoothed surfaces also make cleaning easier. Positive pressure designs, implemented at the project’s discretion to the range between 15-25 Pa against surrounding lower-grade spaces, enable a cascade to limit the inflow of contaminants when doors are closed.
The pressure requirement is dependent on the layout of the facility as well as the doors, the exhaust systems, the process related hazards and relevant regulations. Negative pressure or specialized containment configurations also require a separate risk-based design.
Stable Environmental Control
Systems can be engineered to control temperature and relative humidity to support the quality of the product and to improve the comfort of personnel as well as provide a greater degree of process consistency. Continuously operating temperature, humidity, differential air pressure and airborne particles sensors can be integrated with alerts and trend recording.
Environmental requirements are defined based on the user requirement specification as well as the process sensitivity, occupancy, climate, and equipment. They should not be derived from the ISO cleanliness class.
Applicable Standards and Compliance Basis
Each ISO 5 Hardwall Cleanroom is built according to the user requirement specification and the standards applicable to the relevant process. The compliance framework of the project 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
The performance of a system can be assessed by measurements taken by calibrated instruments and a mutual acceptance criterion. Depending on the dimensions of a project, commissioning and qualification may incorporate particle counting, filter integrity tests, measurement of airflow velocity and uniformity, visualization of airflow, verification of differential pressure, temperature and relative humidity mapping of room conditions, recovery tests and inspections of enclosures.
Where complete records are provided at the time of handover, these may include equipment data sheets, certificates of filters and calibration of instruments, test reports, descriptions of controls, manuals for operation and maintenance, and drawings showing the as-built condition of the system. Documentation to support IQ/OQ can also be prepared based on the project requirements.
Unambiguous Statement of Performance
ISO 5 performance cannot be achieved by specifying a filter type, airflow rate or equipment. Classification of a room is a function of the enclosing system with consideration to sealing of the enclosure, airflow distribution, occupancy, process equipment, operation, and maintenance. Therefore, claims of performance should be substantiated by site tests, documented acceptance criteria and a requalification protocol.
Validation & Delivery
The validation process and delivery for an ISO 5 Hardwall Cleanroom necessitates onsite classification in compliance with ISO 14644-1; verification is by airborne particle concentration compared with ISO Class 5 limit of ≤3,520 particles ≥0.5 μm/m³ under agreed as-built, at-rest or operational conditions. The defined scope of handover may include integrity test of H14 HEPA or ULPA filters, airflow velocity and uniformity measurements, confirmation of differential pressure, visualization of airflow, measurements of temperature and RH, calibration of measuring equipment, identification of approved sampling sites, inspection of hardwall construction, and provision of test report, calibration certificates, as-built plans, operation and maintenance manuals.
Utilize the calibrated equipment with valid certificates for calibration.
Stabilize the HVAC and filtration systems before proceeding with the tests.
Fix the agreed parameters for testing as defined in as-built, at-rest or operational conditions.
Confirm sampling sites according to ISO 14644-1.
Conduct testing of HEPA or ULPA filter integrity as well as of airflow induced by the system.
Confirm parameters of airflow stability, uniformity and direction during the process.
Inspect differential pressure, operation of locks and sealing of hardwall.
Fix errors and prepare documentation to confirm remediation tests.
FAQ
Yes. Deiiang ISO 5 Hardwall Cleanrooms satisfy requirements of ISO 14644 and ISO Class 5 when operated under the specified conditions. Final classification is achieved through on-site testing that consists of airborne particle counting, measurements of airflow and pressure, and testing the integrity of the HEPA/ULPA filters.
ISO 5 Hardwall Cleanrooms are typically equipped with two options. Either terminal HEPA filters with a minimum efficiency of 99.995% (HEPA H14), or ULPA filters in cases where the process requires higher filtration. Vertical or horizontal unidirectional flow design is typically used to achieve an average air flow velocity of 0.2 – 0.45 m/s and adequate airflow to maintain the ISO 5 particle limits throughout the Cleanroom.
Testing prior to hand-over may include airborne particle counting in accordance to ISO 14644-1, integrity testing of the HEPA/ULPA filters, measurement of airflow and its uniformity, verification of pressure, temperature and relative humidity, visualization of airflow and airflow recovery. The hand-over package may also contain calibrated instruments and their certificates as well as other relevant test reports.
Hardwall systems provide stable, sealed environments that support the desired airflow and positive room pressure. Additionally, the systems incorporate ease of cleaning surfaces with little to no shedding, sealed joints, flush mounted components, and monitoring of controlled personnel and materials traffic. As the systems include finish options to accommodate various cleaning agents and processes, the systems can allow for the selection of material options that best fit the process.
Deiiang can supply qualification and validation documentation. Depending on the extent of the work, Deiiang can supply design specifications, as built drawings, records of materials and components, certificates of filters, certificates of instrument calibration, reports on the count of particles, and tests on airflow and pressure as well as a report of the integrity of the filters. The documentation can be used to support IQ, OQ and validation of cleanrooms for the manufacture of pharmaceuticals, medical devices, and other biotechnology as well as controlled environments.
Deiiang offers preventative maintenance through the inspection of performance, and the provision of replacement pre-filters and HEPA or ULPA filters. Deiiang also offers requalification. Recommended maintenance includes the inspection of seals and doors, approval and cleaning of surfaces, differential pressure checks, assessment of airflow, and requalification based on the regulations and ISO 14644-2 and the risk based maintenance program.
Ventilation Times (ACH)
| ISO Class | ACH (Air Changes Per Hour) |
|---|---|
| ISO 3 | 360 - 540 |
| ISO 4 | 300 - 540 |
| ISO 5 | 240 - 480 |
| ISO 6 | 50 - 60 |
| ISO 7 | 30 - 40 |
| ISO 8 | 15 - 25 |
CE Certificate for Deiiang Air Shower and HEPA Filters
Electromagnetic Compatibility EMC Certification
Filter CE-Certification
Deiiang Hardwall Cleanrooms Quality Control Flowchart
