Which industry needs the cleanest cleanroom?

Semiconductor manufacturing generally needs the cleanest air, reaching ISO Class 3 to 5 at the most sensitive lithography and wafer steps. A single sub-micron particle can ruin a device. Pharmaceutical aseptic processing runs almost as clean at its Grade A core, and adds the strictest documentation of any industry.

How do cleanroom requirements differ by industry?

The governing standard differs first. Pharma answers to GMP grades, with limits at rest and in operation. Biotech adds containment, with air running inward. Semiconductors and electronics chase far cleaner air plus static control. Food pairs its class with a hygiene rulebook. Data centres size control to the cooling.

Do all cleanrooms follow the same standard?

No. Almost every cleanroom cites a cleanliness class from ISO 14644-1, the shared particle standard, so the industries speak a common language for clean air. Each adds its own framework on top: EU-GMP grades in pharma, biosafety levels in biotech, static control in electronics, hygiene rules in food.

Is a food cleanroom the same as a pharmaceutical cleanroom?

No. A food cleanroom is not graded A to D like a pharma room. It runs an ISO particle class and a food-hygiene framework side by side: HACCP, FSSAI and food-GMP. Surfaces are hygienic and washdown-ready. Specifying pharma grades for a food line adds cost the process never needed.

What ISO class does my industry need?

As a rough guide: semiconductors run ISO 3 to 6, and pharma and biotech run ISO 5 to 8. Electronics sits at ISO 6 to 8, and solar and food run ISO 7 to 8. Data-centre white space is typically ISO 8. Your process step and governing standard set the exact target.

Industries we engineer for

Cleanroom solutions by industry

The industry decides the spec, not the other way round. We are sector agnostic: a different rulebook every time, one engineering team that builds to all of them.

Talk to an engineer Compare the sectors

ISO 14644-1
EU-GMP Grade A to D
BSL-2 / BSL-3
ULPA U15 to U17
IEC 61340-5-1
HACCP / FSSAI
Schedule M

The industriesTypical target

Each industry answers to a different governing framework, so the same four walls do a different job in each one.

In one line

Every industry asks something different of a cleanroom, because the room is engineered around the work inside it. That is the whole idea behind cleanroom solutions by industry. Pharmaceuticals, biotechnology, semiconductors, electronics, solar, data centres and food and beverage are the industries that use cleanrooms for their most sensitive work. Each answers to a different rulebook. Each sets a different bar for how clean is clean enough. So the same four walls do a very different job in each one.

What this page answers

Which framework governs my industry
What ISO class or GMP grade it targets
What changes against a generic cleanroom
Where the proof for my sector lives

Grade A to D in pharmaceutical: EU-GMP
Containment levels in biotechnology: BSL-3
U15 to U17 in semiconductor: ULPA
ESD practice in electronics: IEC 61340
With FSSAI in food and beverage: HACCP

The starting point

Why the industry decides the spec, not the other way round

Two cleanrooms can look identical from the corridor and be built to completely different rules. A vaccine suite, a wafer fab, a battery dry room and a dairy line all keep contamination out. But the industry decides what counts as contamination, how clean the air must be, and even which direction the air should move. Get that starting point wrong and you pay for it twice. Either you overspend on a class you never needed, or you underbuild a room that fails its first audit. So the first question is never how big or how much. It is what work runs in here, and who inspects it.

The answer names your governing standard. For most industries that standard is ISO 14644, the shared rulebook for clean air, with the industry's own framework layered on top. The standard fixes your target: a cleanliness class, or for medicines a grade from EU-GMP Grade A to D. That target then sets almost everything else. It sets the air-change rate, measured in ACPH. It sets the pressure cascade that keeps air moving the right way between rooms. It decides whether HEPA or ULPA filters carry the ceiling. And it shapes the finishes, the humidity and the dew point the room must hold. It also defines the paperwork. Every regulated room carries a file that proves it does what it claims: the design, installation, operational and performance qualification record. All of these industries follow the same discipline. Only the numbers change.

The chainTop down

Link A
The work
What process actually runs in the room.
Link B
The inspector
Who audits it, and against what.
Link C
The standard
ISO 14644-1, plus EU-GMP, BSL, SEMI, IEC 61340 or HACCP.
Link D
The class or grade
ISO Class 3 to 8, or Grade A to D.
Link E
Everything else
Filters, ACPH, pressures, finishes and the paperwork.

FIG. 01Each link decides the next. Change the industry at the top and every number below it changes with it.

One drawing, seven readings

How cleanroom requirements change by industry

Scroll the industries. The room stays the same. The class, the pressure sign, the controlling risk and the air pattern do not.

What changes as you scroll

01: The class band. Which ISO rungs and GMP grades the industry targets.
02: The ceiling. Full FFU array, a unidirectional core, or mixed diffusers.
03: The pressure sign. Air held outward, or held inward to contain an agent.
04: The controlling risk. The thing that actually ruins the process in that room.

Pharmaceutical
Biotechnology
Semiconductor
Electronics
Solar and PV
Data centre
Food and beverage

Scroll to change industry

01 / 07

Pharmaceutical

ISO 14644-1 class scale+15 Pa outward

Governing standard: ISO 14644-1, EU-GMP Annex 1, Schedule M, WHO-GMP
Target class: ISO Class 5 to 8, mapped to EU-GMP Grade A to D
Pressure regime: Positive, a mapped cascade of roughly 10 to 15 Pa between adjacent grades
Controlling risk: Viable and non-viable particles, counted at rest and in operation
Air pattern: A unidirectional Grade A core over the critical zone, mixed flow around it

02 / 07

Biotechnology

ISO 14644-1 class scale-15 Pa inward

Governing standard: ISO 14644-1 with BSL-2 and BSL-3 biosafety practice
Target class: ISO Class 5 to 8 alongside a BSL-2 or BSL-3 containment level
Pressure regime: Negative, the air held inward so nothing leaves the suite
Controlling risk: A live biological agent escaping the envelope
Air pattern: Inward cascade, HEPA on the exhaust as well as the supply, a sealed and gas-fumigable envelope

03 / 07

Semiconductor

ISO 14644-1 class scale+15 Pa outward

Governing standard: ISO 14644-1 with SEMI practice
Target class: ISO Class 3 to 6, with assembly and test to ISO Class 7
Pressure regime: Positive, held tightly across the whole fab shell
Controlling risk: Sub-micron particles and airborne molecular contamination (AMC)
Air pattern: A near-full fan-filter-unit ceiling, unidirectional downflow, ULPA U15 to U17

04 / 07

Electronics

ISO 14644-1 class scale+15 Pa outward

Governing standard: ISO 14644-1 with IEC 61340-5-1 for ESD
Target class: ISO Class 6 to 8 inside an ESD-protected area (EPA)
Pressure regime: Positive, with a controlled dew point held in the dry room
Controlling risk: Electrostatic discharge and moisture, as much as particles
Air pattern: Mixed flow over a grounded EPA, with battery and Li-ion work in a dry room

05 / 07

Solar and PV

ISO 14644-1 class scale+15 Pa outward

Governing standard: ISO 14644-1
Target class: ISO Class 7 to 8, held evenly across a large production footprint
Pressure regime: Positive, held evenly across wide clear spans
Controlling risk: Particles and handling damage on high-value cells
Air pattern: Mixed flow zoned across the hall so the class holds shift after shift

06 / 07

Data centre

ISO 14644-1 class scale+15 Pa outward

Governing standard: ISO 14644-1
Target class: ISO Class 8 in the white space
Pressure regime: Positive, sized to the cooling airflow rather than to a laboratory number
Controlling risk: Heat load first, particulate second, and never fighting the cooling
Air pattern: Filtration and pressure sized around cold-aisle containment

07 / 07

Food and beverage

ISO 14644-1 class scale+15 Pa outward

Governing standard: ISO 14644-1 with HACCP, FSSAI and food-GMP
Target class: ISO Class 7 to 8, with no EU-GMP grades
Pressure regime: Positive, over hygienic washdown-ready surfaces
Controlling risk: Microbiological and hygiene risk, plus temperature and humidity
Air pattern: Mixed flow with tight temperature and humidity control on dairy and beverage lines

Same section. Same seven walls. Seven different specifications.

Section viewNot to scale

01 / 07
ISO 5 to 8
Pharmaceutical
Grade A aseptic core
Risk: viable and non-viable particles
02 / 07
ISO 5 to 8
Biotechnology
BSL-3 containment suite
Risk: a live agent leaving the envelope
03 / 07
ISO 3 to 6
Semiconductor
Lithography and wafer handling
Risk: sub-micron particles and AMC
04 / 07
ISO 6 to 8
Electronics
SMT line and battery dry room
Risk: electrostatic discharge and moisture
05 / 07
ISO 7 to 8
Solar and PV
Cell and module line
Risk: particles and handling damage
06 / 07
ISO 8
Data centre
White space, cold aisle contained
Risk: heat load first, particulate second
07 / 07
ISO 7 to 8
Food and beverage
Filling and packing hall
Risk: microbiological and hygiene control

Filtered supply air
Pressure across the door
Target class band

FIG. 02One cleanroom section, read seven ways. ISO 14644-1:2015 limits are the maximum permitted particles 0.5 micron and larger per cubic metre. The EU-GMP grade column is the at-rest equivalence and applies to the pharmaceutical reading only. The pressure differentials shown are typical design values, not figures the standard sets.

This is the single reference you can lift to brief a facility. It compares cleanrooms by industry: the governing standard, the usual cleanliness target, and what actually changes on site. Each row is a public standards fact, so nothing here is a Fabtech-specific claim.

Governing standard, typical ISO class or GMP grade and what changes, by industry
Industry	Governing standard(s)	Typical ISO class / GMP grade	What changes vs a generic cleanroom
Pharmaceutical	ISO 14644-1, EU-GMP Annex 1, India's Schedule M, WHO-GMP	ISO 5-8 / EU-GMP Grade A-D	The room carries two particle limits, one at rest and one in operation; a mapped pressure cascade; a unidirectional (laminar) Grade A core; and a full DQ/IQ/OQ/PQ dossier with a Contamination Control Strategy.
Biotechnology	ISO 14644-1, BSL-2 / BSL-3 biosafety practice	ISO 5-8 / BSL-2-3 containment	The air runs inward under negative pressure to contain a live agent, the opposite of a pharma room; HEPA sits on the exhaust, not just the supply; the envelope is sealed and gas-fumigable.
Semiconductor	ISO 14644-1, SEMI practice	ISO Class 3-6 (assembly and test to ISO 7)	Far cleaner classes; near-full fan-filter-unit (FFU) ceilings; ULPA U15-U17; airborne molecular contamination (AMC) filtration; and tight vibration and heat-load control.
Electronics	ISO 14644-1, IEC 61340-5-1 (ESD)	ISO 6-8 / ESD-protected area (EPA)	Electrostatic discharge control across a grounded EPA matters as much as particles; battery and Li-ion work needs a dry room held to a controlled dew point.
Solar and PV	ISO 14644-1	ISO 7-8	A large production footprint has to hold its class evenly, shift after shift, across wide clear spans, protecting high-value cells from particles and handling damage on mono, poly and thin-film lines.
Data centre	ISO 14644-1	ISO Class 8 (white space)	Contamination control has to support the cooling and cold-aisle containment, not fight it; air filtration and positive pressure are sized to the heat load, not to a lab number.
Food and beverage	ISO 14644-1 with HACCP, FSSAI, food-GMP	ISO 7-8	Two rulebooks run at once, an ISO particle class and a food-hygiene framework; surfaces are hygienic and washdown-ready; dairy and beverage lines lean hard on temperature and humidity control, and there are no EU-GMP grades.

FIG. 03Public standards references: ISO 14644-1, EU-GMP Annex 1, India's Schedule M, IEC 61340-5-1, HACCP and FSSAI.

How to read the table: the cleanest rooms belong to semiconductors, where one stray particle can ruin a device. Pharmaceuticals go nearly as clean at the aseptic core, then add the strictest paperwork of any industry. The rest sit cleaner or dirtier depending on what a particle actually costs the process. Find your row, then follow it to the industry page below for the room types, applications and proof behind it.

Where the class numbers come from

ISO 14644 classification explains how a target class is set, tested and held on site, and what the at-rest and in-operation numbers actually mean.

ISO 14644 classification

Route

Find your industry

Each industry below has its own detailed page. Every page covers the classification, the cleanroom applications we engineer for, the room types and the proof.

01ISO 5 to 8

Pharmaceutical

Two particle limits per room, a proven pressure cascade and a validation dossier written to pass inspection, with the air system designed alongside the room rather than after it.

pharmaceutical cleanrooms and GMP HVAC

The constant

What stays the same across every industry

A different rulebook every time. One build system.

Seven into oneConverging

PharmaceuticalEU-GMP
BiotechnologyBSL-3
SemiconductorSEMI
ElectronicsIEC 61340
Solar and PVISO 14644
Data centreISO 14644
Food and beverageHACCP

One build system

FIG. 04Seven governing frameworks set seven different targets. The engineering that meets them, and the team accountable for it, does not change.

The standard changes with the industry. The way the room gets built does not. Whatever the class or grade, the same engineering spine sits underneath, and one team owns it from the first design conversation to handover.

We manufacture the core of every cleanroom in our own facility. That starts with modular wall and ceiling systems with PUF and Rockwool infill as standard. Honeycomb-infill panels are supplied where a project specifies them. On the air side we build the air-handling units, the terminal HEPA housings and the fan-filter units (FFUs), each sized to the target class and proven on handover. We also build laminar airflow (LAF) units, pass boxes, air showers, cleanroom doors and biosafety cabinets. Building the equipment and the room with one engineering team is why the design that holds your class is the design that actually gets installed. That is true whatever the sector.

Built in our own facility

That spine connects to the rest of the work across the site:

Proof

Proof across industries

In pharmaceuticals, our delivered work includes the GMP oral-solids facility at Ajanta Pharma, Aurangabad. Desano (Bangalore) and German Remedies are further delivered pharmaceutical projects. In high-containment biotechnology, we designed, built and validated the BSL-3 laboratories at PGICH Noida and ASMC Shahjahanpur. We have also delivered research cleanroom work for BARC. For electronics, we delivered an electronics-grade particle and ESD-protected manufacturing cleanroom for Bosch, Nashik. The exact class, area and scope of each site are available on request.

Solar and data-centre lines draw on the same contamination-control and modular-cleanroom engineering proven in the delivered work above. That means even-class control across large clear-span halls, and white-space particle control sized to the cooling load.

Delivered cleanroom projects Ajanta Pharma case study

Delivered work

2,000+ ROOMS / SINCE 2004

Ajanta Pharma, AurangabadGMP oral solids
Desano, BangalorePharmaceutical
PGICH NoidaBSL-3 laboratory
ASMC ShahjahanpurBSL-3 laboratory
BARCResearch cleanroom
Bosch, NashikElectronics, ESD-protected area

Why Fabtech

Why Fabtech, whatever the sector

We have delivered more than 2,000 controlled environments since 2004, across every one of these industries. One accountable engineering team designs, manufactures, installs and validates the room, instead of handing the job across a chain of vendors. That single line of accountability is why the room briefed in the first meeting is the same room that passes on test day.

Behind that accountability sit named delivered work, in-house manufacturing, and a validation dossier written to withstand inspection under EU-GMP, US-FDA, WHO-GMP and cGMP expectations.

About Fabtech Cleanrooms

Written to withstand

EU-GMP
US-FDA
WHO-GMP
cGMP

Regulators inspect a facility, they do not certify the company that builds it. The dossier is written so the inspection has something complete to read.

Standard to class
Design
We start from the process and the regulator, then set the ISO class or GMP grade, the zoning and the air strategy that will hold it.
In our own facility
Manufacture
Panels and ceilings, LAF units, pass boxes, air showers, doors and biosafety cabinets are built to the design that was signed off.
One team on site
Install
The same engineering team that drew the room builds it, so the design that holds your class is the design that actually gets installed.
DQ / IQ / OQ / PQ
Validate
The room is proven on record against its target class, its pressure cascade and its recovery, and handed over with the dossier.

FIG. 05One accountable engineering team, from the first design conversation to the validated handover.

FAQ