Planning a cleanroom for electronics, medical devices, pharma or food packing? Understand the class, the room and the air system before you brief anyone.
A cleanroom is a room where airborne particles are kept below a set limit by filtered air, sealed surfaces, pressure control and disciplined entry, and its cleanliness is graded by ISO 14644-1 classes from ISO 1 (cleanest) to ISO 9 (roughly ordinary room air). The class your product or customer needs drives almost every cost: the air system, the panels, the airlocks and the testing. A cleanroom is a specialist design-and-build job with validation at the end, so fix the class and the process first, then plan the building works around it. A site visit is RM150, waived if you go ahead.
A cleanroom is not simply a very clean room. Wikipedia's Cleanroom article describes air constantly recirculated through high-efficiency particulate (HEPA) or ultra-low particulate (ULPA) filters, with special lighting, walls and materials chosen to minimise airborne particles, and temperature and humidity controlled. People are the biggest source of contamination, so staff enter through airlocks and wear protective clothing.
Many cleanrooms are kept at positive pressure, so that any leak pushes air out rather than drawing unfiltered air in. Rooms handling hazardous organisms are the opposite: they are held at negative pressure. Which one you need depends on whether you are protecting the product or protecting people outside the room.
ISO 14644-1 grades a cleanroom by how many particles of a given size are allowed in each cubic metre of air. Older specifications still quote the US FED STD 209E classes, so it helps to know how they line up. The class equivalents below are from the Wikipedia article; the right-hand column is general guidance only:
| ISO 14644-1 class | Old FED STD 209E equivalent | What it means in practice |
|---|---|---|
| ISO 5 | Class 100 | Very clean; semiconductor facilities often work at this level or at ISO 7 |
| ISO 6 | Class 1,000 | Clean process rooms |
| ISO 7 | Class 10,000 | A common working level for controlled production |
| ISO 8 | Class 100,000 | Least strict common cleanroom class; often gowning and support areas |
| ISO 9 | Around ordinary room air | The reference point: normal indoor air |
Each step cleaner means more filtered air, tighter construction and more testing, so a class tighter than your process needs is money spent for nothing. Your quality team, your customer's specification or your regulator should set the class, not the contractor.
In Malaysia the usual buyers are electronics and semiconductor assembly, medical device makers, pharmaceutical and cosmetic manufacturers, laboratories, and some food and packaging lines with a customer requirement for a controlled zone. Regulated products follow their own good manufacturing practice rules, which may add requirements beyond the ISO class — Wikipedia notes the separate EU GMP grades, for example. Confirm these with your quality or regulatory adviser before design starts.
Not every dust problem needs a cleanroom. Dust from a weak concrete floor, or fumes at a workstation, are often better solved at the source; ClickBina's factory floor repair guide and local exhaust ventilation guide cover those cases.
Every surface must be smooth, non-shedding, easy to clean and sealed at every joint. In practice that means:
The air system is the heart of the cleanroom and the largest single cost. It usually includes an air handling unit, HEPA filters in the ceiling or fan filter units, return air grilles low on the walls, and controls for temperature, humidity and room pressure. Rooms are arranged in a pressure cascade, from the cleanest room outward, so air always flows from clean to less clean.
How much air is needed, how it is filtered and how it is controlled are design decisions for a specialist HVAC or cleanroom engineer, tied to the class and the heat from your process. Ordinary office or shop aircon is not a substitute; ClickBina's office aircon guide covers comfort cooling, which is a different job.
Wikipedia describes the two principles. In a laminar (unidirectional) room, filtered air moves in a steady stream, usually downward, towards returns near the floor, sweeping particles away from the work. In a turbulent (non-unidirectional) room, filtered air mixes with the room air and dilutes the particles. Laminar airflow is used for the most demanding zones and costs much more; many rooms use turbulent airflow overall with laminar flow hoods or benches only where the product is exposed.
| Element | What it does | Plan for |
|---|---|---|
| Gowning room | Staff change into cleanroom clothing before entering | Benches, lockers, a clear step-over line |
| Airlock | Two doors that do not open together, keeping pressure between rooms | Door interlocks and space for both doors |
| Air shower | Blows loose particles off people as they enter | Space in the entry sequence and power |
| Pass box | A small chamber in the wall for passing materials in and out without people | Wall position, interlocked doors, size of items |
| Material airlock | A larger airlock for trolleys and equipment | Door sizes and floor finish |
Getting the flow of people and materials right is as important as the class. Draw the route from the street to the workstation, and back out, before the walls are fixed.
| Stage | What happens | Who is involved |
|---|---|---|
| 1. Requirements | Product, process, target class, pressure regime and standards agreed in writing | Owner, quality team, customer or regulator |
| 2. Design | Layout, air system, panels, entry sequence, services | Specialist cleanroom designer, engineers |
| 3. Approvals | Landlord consent, building and fire approvals where required | Owner, consultants, contractor |
| 4. Base building works | Slab repair, openings, power, drainage, roof or wall penetrations | Main contractor and trades |
| 5. Cleanroom installation | Panels, ceiling, air system, filters, doors and pass boxes | Specialist cleanroom contractor |
| 6. Testing and handover | Classification testing, pressure and airflow checks, documents | Specialist, independent tester, owner |
Plan the testing at the start: the room is only finished when it has been tested and shown to meet the class it was designed for.
ClickBina does not publish cleanroom prices, because they depend almost entirely on the design. The main cost drivers are:
A cleanroom is building work inside a factory or lab, so the usual rules apply: the landlord's written consent for alterations and for any plant on the roof or walls, and building and fire approvals where the local council or fire authority requires them — panel fire ratings and escape routes through airlocks are common questions. Regulated manufacturers must also meet their regulator's good manufacturing practice requirements. At the end of a lease, the cleanroom may have to be removed, so keep the reinstatement cost in the business plan. Check each requirement with the relevant authority and your consultants; they vary by site and product.
WhatsApp us your job details for a quote. It helps to send:
ClickBina handles commercial renovation and fit-out works and coordinates the trades. For a cleanroom, ClickBina coordinates the base building works — slab, openings, power, drainage, ceilings and surrounding fit-out — with the specialist cleanroom contractor who designs, installs and tests the room itself. ClickBina is an experienced KL & Selangor contractor, we reply within the hour, and the price we agree is a flat price with no hidden charges. A site visit is RM150, waived if you go ahead.
Methodology: class equivalents are taken from the Wikipedia article above; confirm the requirements of your product against the current ISO 14644 standard and your customer or regulator. ClickBina publishes no cleanroom price, so none is given.
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