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عربىTechnical Parameters and Qualification Activities
The stages build on each other. Your validation master plan, your risk assessment and the standards you follow define the exact tests. The table shows typical activities for a cleanroom, with common references such as ISO 14644 and EU GMP Annex 15.
| Stage | Purpose | Typical activities |
|---|---|---|
| DQ | Show the design meets the user requirements | Review of drawings, specifications and risk assessment |
| FAT (factory acceptance) | Check equipment at the factory | Function tests of doors, interlocks, Pass Boxes, booths |
| IQ | Show the room is installed as designed | Check of components against drawings, material records, calibration status, utilities |
| OQ | Show the room operates within set limits | HEPA leak tests, airflow volume and velocity, pressure differentials, interlock and alarm tests, temperature and humidity mapping |
| PQ | Show the room performs under real conditions | Particle counts at rest and in operation, recovery tests, airflow visualization, microbial monitoring |
| Re-qualification | Show continued performance | Periodic tests, commonly every 6 months for ISO 5 or cleaner and 12 months for others |
Common test methods (ISO 14644-3 and related):
- Airborne particle count: sampling locations and volumes follow ISO 14644-1.
- Installed filter leak test: aerosol photometer or particle counter scan of each HEPA filter and its seal.
- Airflow: velocity at terminal filters and air change rate.
- Pressure differential: between rooms, with calibrated gauges.
- Recovery: time for a room to return to class after a challenge.
- Airflow visualization: smoke studies to show flow patterns.
Our staff reply promptly and in plain language, and our designers can adapt standard layouts to your building and your process.
Cross-Border Delivery and Localized Construction Support
Qualification starts long before the testing day. For overseas projects, the paperwork that will be needed at IQ should be collected during manufacture and shipping, not rebuilt afterward. We therefore prepare documents along the way.
- Document plan: we agree with your team which documents are needed for DQ, FAT and IQ.
- Factory stage: we record inspection results, function tests and filter data, and can support witnessed tests.
- Shipping stage: packing lists and batch records link each item to its documents.
- Installation stage: checklists and as-built drawings are kept during construction.
- Test stage: we answer technical questions and provide information to the testers.
Local conditions: testing companies and calibration services differ by country. Plan early who will perform the tests, with which instruments, and when, since qualified testers may have waiting times. Local regulators may also require a local entity or specific accredited laboratory.
To avoid failure at OQ, the room should be clean, sealed and balanced before testing begins, with HEPA filters installed and the HVAC commissioned. Your team remains responsible for protocols, execution and approval, and we support them with technical information.
Please also tell us your validation timeline and the date of your inspection or audit. Working backward from that date, we can agree when each document must be ready and when shipments must arrive, so that qualification is not delayed by missing papers.
Staged shipments can also be arranged when the building is handed over in phases.
Our staff reply promptly and in plain language, and our designers can adapt standard layouts to your building and your process.
Quality Control and Certification
Qualification relies on traceable records. No wall panel or door is "validated" on its own, since validation applies to the finished room and its operation. We make sure the parts we supply come with the records that your validation file needs.
| Record | Content | Use in qualification |
|---|---|---|
| Material specification | Face, core, profiles, gaskets, glass | IQ component identity |
| Factory inspection record | Dimensions, flatness, bonding, edge sealing | IQ and acceptance |
| Function test record | Interlock, door, Pass Box, booth tests | FAT and OQ preparation |
| Filter record | Factory efficiency and leak test data | HEPA traceability |
| Wiring diagram | Interlocks, controls, alarms | OQ planning |
| As-built drawings | Final layout and details | IQ reference |
| Batch and packing records | Link between items and documents | Traceability |
Documents available: the records above and, where available, reports on fire or surface performance. Please give us your document list early. We will confirm what exists and will not claim records that do not exist.
Customer audits of our factory, witnessed factory tests and sample approvals are welcome, and we can adjust our schedule to your FAT plan.
Validation teams and auditors often ask how component records are kept and linked to the installed rooms. We use position codes and batch numbers that connect each panel, door and filter to its inspection record, and we share the system with you. Our factory can host audits or witnessed tests.
We recommend agreeing the document list and the format of records at the start, so that nothing is missing when the IQ binder is assembled.
Our staff reply promptly and in plain language, and our designers can adapt standard layouts to your building and your process.
After-Sales Service and Response Capability
Qualification is not a one-time event. Rooms are re-qualified regularly, and any change must be assessed. We keep complete project records that help with each cycle.
- Fast communication: technical questions answered in English by email, phone or messaging.
- Document retrieval: we can re-send records, drawings and certificates when your auditors ask.
- Failure analysis support: if a test fails, we review photos and data to help find the cause.
- Change support: updated drawings and component information for change control.
- Spare parts: like-for-like parts that keep the qualified state.
Common test failures and likely causes:
| Failure | Possible cause | Suggested action |
|---|---|---|
| HEPA leak at filter edge | Poor seal or damaged filter | Re-seat or replace filter, retest |
| Pressure below target | Leaks at joints or doors, HVAC balance | Seal, replace gasket, rebalance |
| Particle counts high at rest | Dirty room, filter leak, poor cleaning | Clean, fix leak, retest |
| Slow recovery | Low air changes or poor airflow pattern | Review HVAC and layout |
Keep baseline results from the first qualification, which help detect slow changes over time.
When a re-qualification test fails or drifts, speed and clarity matter. Please send the test report, the room name, the date and any recent changes, such as new equipment, new openings or filter changes. Our engineers will compare them with the project drawings and records and suggest likely causes and corrective steps.
Replacement parts are made to the original specification, so the qualified state is kept. For urgent cases, we discuss the fastest shipping option and prepare documents in advance.
A small stock of gaskets, sealant and filters at the site helps you act the same day.
Commercial Terms, Warranty and Lifecycle Cost
Qualification has a cost in time, testing and documents, and failing a test costs more. A well-built, well-documented room usually qualifies faster and needs fewer repeats.
| Item | Our approach |
|---|---|
| Standard documents | Material specifications, factory records, wiring diagrams provided with the order |
| Extra documentation | Additional document packs or witnessed tests can be quoted separately |
| Trade terms | FOB, CFR or CIF, defined in the quotation |
| Payment | Commonly a deposit with balance before shipment or against documents; final terms in the contract |
| Warranty | Defined by component group in the contract |
| Third-party testing | Arranged and paid by the owner unless agreed otherwise |
Where qualification cost is decided:
- Number of rooms and grades: each room needs its own tests.
- Re-test frequency: cleaner classes need more frequent testing.
- First-time pass rate: sealing and installation quality reduce repeats.
- Documentation effort: clear records from the start reduce consultant time.
Protocol writing, testing, calibration, consultants and regulatory fees are outside our supply unless agreed. Warranty exclusions are stated clearly in the contract.
When budgeting for qualification, include the cost of instruments and their calibration, tester time, repeat tests, consultant time and document control. The earlier these are planned, the less they surprise the project.
We provide itemized quotations for our supply and for optional document packs, and we are glad to explain every line.
Our staff reply promptly and in plain language, and our designers can adapt standard layouts to your building and your process.
We are glad to explain every line of our quotation and to prepare alternative options if you need to adjust the budget.
Real Factory Strength Behind Our Documentation
Good records start in a well-run factory. Pharma United Co., Ltd., founded in 2006, runs two factories in Kunshan and Qianjiang covering 20,000 m², with more than 60 staff. We are a manufacturer, not a trading company.
| Indicator | Information |
|---|---|
| Experience | 20+ years in cleanroom engineering |
| HPL cleanroom panels | About 250,000 m² per year; China's largest HPL cleanroom panel manufacturer |
| Container shipments | More than 1,000 forty-foot high-cube containers per year |
| Location | Kunshan, about 30 km from Shanghai |
| Product range | Panels, doors and windows, equipment, modular PODs, HEPA products |
| Service | Design, manufacture and installation support |
Why this helps validation teams: because we manufacture panels, doors, windows and equipment ourselves, inspection records and batch information come directly from the people who made the parts. Our experience with pharmaceutical and hospital projects helps us understand what validation teams ask for.
Customers can visit the factory, witness tests, review production records and see sample panels. A showroom video is available for remote review.
Our designers prepare as-built drawings, our engineers review test-related details, and our production teams keep records for panels, doors, windows and equipment. Export coordinators prepare packing and documents for shipments to many countries.
Customers in pharmaceutical and hospital fields return for new rooms and spare parts, and we can share sample records on request. Visitors are welcome at our factory by arrangement.
Our staff reply promptly and in plain language, and our designers can adapt standard layouts to your building and your process.
We are glad to explain every line of our quotation and to prepare alternative options if you need to adjust the budget.
Cleanroom Validation IQ/OQ/PQ FAQ
Q1. What do IQ, OQ and PQ mean?
Installation qualification checks that the room is installed as designed. Operational qualification checks that it works within set limits. Performance qualification checks that it performs under real conditions.
Q2. Do you perform the validation?
No. Validation is carried out by your team or an independent qualified company. We support it with drawings, records and technical answers.
Q3. Are your panels validated?
No product is validated alone. Validation applies to the whole room and its operation. Our components come with records that support your file.
Q4. How often is re-qualification needed?
Commonly every 6 months for ISO 5 or cleaner and about every 12 months for other classes, but your quality system and regulator decide.
Q5. Which tests are done at OQ?
Typical tests include HEPA leak tests, airflow, pressure differentials, interlocks, alarms and temperature and humidity checks.
Q6. Can you witness or support a factory acceptance test?
Yes. We can plan witnessed function tests at our factory for doors, interlocks, Pass Boxes and booths.
Q7. How do I request a document pack?
Send your document list and project details, and we will confirm what we can supply.
Q8. Can you provide sample records before I order?
Yes. We can show typical inspection and function test records, so your team can judge whether they meet your needs.
Q9. Who writes the protocols?
Your validation team or consultant writes and approves them. We provide technical information.
Our staff reply promptly and in plain language, and our designers can adapt standard layouts to your building and your process.
