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عربىTechnical Parameters Linked to ISO 14644
The table gives the maximum permitted particle concentrations for the classes most often specified, together with typical component choices. Design values for air changes and airflow depend on room load, process and heat; your HVAC designer should confirm them using ISO 14644-4 and your own requirements.
| ISO class | Max. particles ≥0.5 µm per m³ | Typical air supply approach | Typical components |
|---|---|---|---|
| ISO 5 | 3,520 | Unidirectional airflow, HEPA or ULPA | Laminar Air Flow, flush panels, interlocked doors |
| ISO 6 | 35,200 | High-rate HEPA supply | Flush panels, Air Shower, Pass Box |
| ISO 7 | 352,000 | Turbulent mixed flow, HEPA supply, often 30–60 air changes per hour | Panels, HEPA Supply Boxes, flush doors |
| ISO 8 | 3,520,000 | Filtered supply, often 10–25 air changes per hour | Economical panels, standard flush doors |
| ISO 9 | 35,200,000 | Filtered air, room air quality | Basic panel systems |
Related standards worth knowing:
- ISO 14644-2 covers monitoring to show continued compliance.
- ISO 14644-3 describes test methods such as particle counts, airflow, pressure difference and filter installation leak tests.
- ISO 14644-4 addresses design, construction and start-up.
- HEPA grades such as H13 and H14 are defined in ISO 29463 and EN 1822.
Our panels, doors and filters can be supplied in sizes and finishes that match your drawings.
Why occupancy state matters: a room classified as-built, with no equipment or people, will produce much lower particle counts than the same room in operation. Many projects therefore specify at-rest and operational targets. We suggest stating both in the URS, so the design team can select the right air change rate and the contractor knows which tests will be requested.
We can adjust panel layouts and door positions to match your airflow design.
Cross-Border Delivery and Localized Construction Support
Because ISO 14644 is used all over the world, our customers come from many countries and construction cultures. We keep the delivery process simple: clear drawings, clear labels and complete documents, so that your local team can build a room that is ready for classification testing.
- Specification review: we confirm the target class, room layout, door positions and equipment list.
- Production: panels, doors and profiles are made to drawing and numbered.
- Export packing: goods are palletized and protected for sea freight in 20GP or 40HQ containers.
- Shipping documents: packing list, commercial invoice and certificate of origin, with FOB, CFR or CIF terms.
- Installation support: manuals, video guidance or an on-site engineer.
Getting ready for classification testing: ISO 14644-1 classification is based on particle counts taken at defined sampling points, in a defined occupancy state, by a competent tester. A room that is well sealed, clean at handover and supplied with correctly installed HEPA filters is more likely to pass the first time. We therefore advise on the final sealing sequence, protection of finished surfaces and cleaning before testing begins.
Local contractors handle civil, HVAC and electrical work, and we coordinate with them on openings, ceiling loads and door thresholds. Final building code and permit responsibility remains with your project team.
For international projects, we also prepare short summaries of the materials and a clear bill of quantities, which your tender or customs team may request. Keeping these documents consistent with the packing list reduces questions at the port and helps the container clear quickly, which keeps your construction schedule on track.
Quality Control and Certification
Many buyers ask for "ISO 14644 certified panels". It is better to explain the facts: ISO 14644 classifies the cleanroom after it is built and tested, and the supplier of walls, doors or filters does not hold an ISO 14644 certificate for the room. What we provide is consistent manufacturing and supporting records.
| Control stage | Inspection | Value for classification |
|---|---|---|
| Incoming material | Facing sheet, core, profiles, gaskets, glass | Known material quality |
| Panel production | Size, flatness, bonding, edge seal | Tight flush joints |
| Surface check | Scratches, bubbles, color, cleanability | Low particle generation |
| Door and equipment | Function test, gasket contact, interlock | Stable pressure and flow |
| HEPA products | Factory efficiency records, visual check | Filter traceability |
| Packing | Piece count, labels, condition | Complete delivery |
Documents available: material specifications, factory inspection records, filter test records and, where available, test reports for fire or surface performance.
For classification, an accredited or otherwise competent third party should carry out testing with calibrated particle counters, and ISO 14644-3 methods for leak, airflow and pressure checks. We can supply drawings and component data that make their work faster, and we welcome factory audits and sample approval before production.
In practice, buyers also want proof that our production is repeatable. We therefore keep batch records and can show you how each panel is checked. If your own quality unit wishes to approve us as a supplier, we are happy to complete questionnaires, provide samples and host an audit, and we will explain any limits in our documentation without exaggeration.
Honest communication helps both sides avoid delays.
After-Sales Service and Response Capability
Keeping an ISO class over years means more than passing the first test. ISO 14644-2 expects continued monitoring, and any damaged door, worn gasket or leaking joint can show up as a trend in your data. Our after-sales service is built to help you find the cause and restore the original condition quickly.
- Project archive: drawings and bills of materials are stored, so we know exactly what was supplied.
- Remote diagnosis: photos, videos and your monitoring trend help us suggest likely causes.
- Replacement parts: gaskets, hinges, closers, handles, windows, lights and HEPA Filters.
- Re-classification support: if you change the room layout or class, we advise which components need to be added or upgraded.
- Engineering visits: available by arrangement for repair or expansion.
Typical causes of a failed or drifting class:
| Symptom | Possible cause | Suggested action |
|---|---|---|
| Particle counts rise | Damaged HEPA Filter, worn surface, poor cleaning | Leak-test filter, inspect surfaces, review cleaning |
| Pressure differential changes | Gasket wear, open penetration, filter loading | Replace gasket, reseal, check filters |
| Slow recovery after activity | Insufficient airflow or layout problem | Review airflow and layout with HVAC designer |
Please keep maintenance records, since they support your own quality documentation.
We recommend that customers keep a baseline report from the first classification test, including particle counts, airflow readings and pressure values. When something changes later, this baseline helps us and your technicians compare results and see whether the cause is a worn component, a filter or a change in operations.
We are glad to review these reports and suggest practical corrective steps.
Commercial Terms, Warranty and Lifecycle Cost
The ISO class of a room is a major driver of cost. Moving from ISO 8 to ISO 7 or ISO 5 increases air supply, filtration, monitoring and construction quality requirements, and therefore the budget. Specifying the class you actually need, and no higher, is the most effective way to control lifecycle cost.
| Item | Our approach |
|---|---|
| Quotation | Itemized by room and component, with drawings |
| Trade terms | FOB, CFR or CIF, defined in the quotation |
| Payment | Usually a deposit with balance before shipment or against documents; final terms in the contract |
| Warranty | Defined by component group in the contract |
| Lead time | Given with the quotation after drawing confirmation |
| Customization | Size, thickness, color, and door layout on request |
Cost drivers to consider:
- Air change rate: the main driver of fan and cooling energy, which is strongly affected by room airtightness.
- Filter replacement: accessible HEPA housings shorten maintenance time.
- Testing and monitoring: classification, annual verification and continuous monitoring are recurring costs.
- Surface life: durable surfaces reduce repair and repainting.
Our warranty terms list exclusions such as damage from unsuitable chemicals or modification without advice, so expectations are clear from the start.
When comparing suppliers, make sure each quotation lists the same items: panel thickness, face material, door type, glass, cove profiles, filters and packing. Differences in scope can easily hide a lower price. We give a full breakdown and are happy to prepare alternative options, so you can see how each choice affects both cost and performance over time.
Real Factory Strength for ISO 14644 Projects
A cleanroom standard is only as reliable as the products used to build the room. Pharma United Co., Ltd. has manufactured cleanroom systems since 2006 and works from two factories in Kunshan and Qianjiang covering 20,000 m², with more than 60 staff. We make the main components ourselves.
| Indicator | Information |
|---|---|
| Experience | More than 20 years |
| HPL cleanroom panels | About 250,000 m² per year, the largest producer in China |
| Container shipments | Over 1,000 forty-foot high-cube containers per year |
| Location | Kunshan, near Shanghai port |
| Product range | Panels, doors and windows, equipment, PODs, HEPA products |
| Service | Design, manufacture, installation support |
Why scale helps: stable raw material supply and long production experience support consistent flatness, color and edge sealing across a large order. That consistency matters when hundreds of joints must stay tight enough to hold pressure in an ISO 7 or ISO 5 room.
Because panels, doors, windows and equipment are made by one company, dimensions and interfaces match, and fewer site changes are needed. Visits, audits, samples and video tours are available, and we can share project references in similar markets.
Our designers, engineers and production supervisors work together on each order, and our export team handles packing and documents. This structure means technical questions on a joint detail, a door size or a filter dimension are answered by people who know the product. Customers regularly return for additional rooms and expansions, which reflects the stability of our service.
Samples, photos and videos of finished rooms are available, so you can judge our workmanship before placing an order.
ISO 14644 Compliant Components FAQ
Q1. Do you hold an ISO 14644 certificate for your panels?
No such certificate exists for building products. ISO 14644 classifies the room after it is tested. Our panels, doors and filters are designed to help a room reach and keep its class.
Q2. How are ISO classes measured?
By counting airborne particles at defined sampling locations, in a stated occupancy state, using the methods of the ISO 14644 series.
Q3. What is the difference between ISO 14644-1 and the older Federal Standard 209E?
209E was replaced by ISO 14644-1. Class 100 is approximately ISO 5, Class 1,000 ISO 6, Class 10,000 ISO 7 and Class 100,000 ISO 8.
Q4. Which HEPA grade do I need?
H13 and H14 are common in pharmaceutical and electronics rooms, while ISO 5 critical zones often use H14 or ULPA. Your designer confirms the grade.
Q5. Can you supply a complete room?
We supply the envelope, doors, windows, equipment and HEPA products, and we coordinate HVAC with your engineer.
Q6. Who performs classification testing?
A competent independent tester or accredited laboratory, after construction and cleaning are complete.
Q7. How do I get a quotation?
Send the target ISO class, floor plan, application and destination country, and we will prepare a proposal.
Q8. Does a higher ISO class always cost much more?
Yes, usually. Each step toward a cleaner class increases air supply, filtration and construction quality, so choose the class your process truly requires.
Q9. Can I upgrade a room to a cleaner class later?
Sometimes. The panel envelope can often stay, while air supply, filters, airlocks and some components are upgraded and the room is tested again.
