Fabtech Cleanrooms

Cleanroom questions, answered

Frequently asked questions

Buying a cleanroom means asking a lot of questions before you commit. These are the ones we hear most, answered plainly. Each answer is short. Each one points to the page that covers the topic in full.

Fifteen questions in five groups. Pick yours below and you land on the answer, not on a search box. Where a subject has real depth, the answer names the page that carries it.

Ask an engineer Open the answer map
  • ISO 14644-1
  • EU-GMP Grade A to D
  • DQ/IQ/OQ/PQ
  • ISO 9001
  • HEPA H13 / H14

Jump to your question

15 answers, 5 groups

  1. 01General and company4 questions

    Who we are, what we build, who we build it for, and what a procurement team can verify.

  2. 02Standards and compliance3 questions

    The rulebooks, what a class number means, and what the validation dossier contains.

  3. 03Equipment2 questions

    What we manufacture, and whether you can buy a single unit without a whole room.

  4. 04Process and delivery3 questions

    What turnkey actually covers, how long a project runs, and what happens after handover.

  5. 05Commercial3 questions

    How a quote is scoped, what actually moves the cost, and where in India we work.

Group 01 / 4 questions

Most first conversations start in the same place. Who are you, what do you actually build, who do you build it for, and can a procurement team check you out before anyone signs.

One company designs the room, makes the core equipment that goes in it, installs it and proves it. That single line is the answer sitting under all four of these questions.

Cleanroom engineering since
2004
Projects delivered
Over 2,000
Industries served
Sector agnostic
Quality system
ISO 9001 certified
Base
Mumbai, Maharashtra, working across India
Scope
Design, manufacture, install, validate, hand over
The four answers

General and company

Fabtech Cleanrooms is an Indian company that designs, builds and validates cleanrooms and makes much of the equipment inside them. Over 2,000 cleanroom projects across every industry that needs controlled air, with cleanroom engineering going back to 2004. One team, from first design meeting to validated handover. More on the About Fabtech page.

About Fabtech

Where the full answers live

The answer map

From a question to the page that carries it

This page answers a question in a paragraph. The page it points to answers it in a chapter. The map shows both halves at once: five question groups on the left, and on the right the pages that carry the depth on each subject.

Standards and compliance runs to the ISO 14644 classification and validation pages, because a class number and a qualification protocol each need more room than an answer box. Equipment runs to the device hubs, where every unit carries its own specification and its own standards. Process and delivery runs to the turnkey cluster, from design through installation to handover. Commercial runs to contact, because a cleanroom cost is scoped, not quoted.

Routing mapFive groups, twelve destinations
  1. 014 questions

    General and company

  2. 023 questions

    Standards and compliance

  3. 032 questions

    Equipment

  4. 043 questions

    Process and delivery

  5. 053 questions

    Commercial

  • Question group
  • Route to the full answer

FIG. 01Five question groups and the twelve pages they route to. On a slow loop each group takes emphasis in turn and its outbound routes illuminate toward their destinations. With motion reduced, every group and every route renders lit, which is the whole site map of where answers live.

Group 02 / 3 questions

Standards and compliance

Every cleanroom answers to somebody. A regulator, an auditor, or a customer who wants to see the paperwork before they place an order. These three answers cover the rulebooks we work to, what the class numbers actually mean, and what the validation dossier contains.

Two of the three answers below are deliberately short. A class number and a qualification protocol each need a chapter rather than a paragraph, so the full versions live on the classification and validation pages and this page hands you to them. The tables under them are the shape of those answers, not a substitute for them.

Question 01

Which standards do you design and validate cleanrooms to?

Turnkey cleanroom services

We design to ISO 14644-1 for clean air, and to EU-GMP Grade A to D for pharmaceuticals. We build for EU-GMP, US-FDA, WHO-GMP and cGMP inspection. Regulators inspect facilities, they do not certify rooms. Every project is handed over with the validation dossier that inspection needs. Our quality system is ISO 9001 certified. See the turnkey cleanroom services page.

The frameworks a Fabtech cleanroom is designed and documented against
FrameworkWhat it sets for your room
ISO 14644-1The airborne particle class we design and test to, ISO Class 5 to 8
EU-GMPThe pharmaceutical grade, Grade A to D
EU-GMP, US-FDA, WHO-GMP and cGMPThe inspections the facility is built to withstand
ISO 9001Our certified quality management system

FIG. 02Regulators inspect facilities. They do not certify rooms.

Question 02

What is the difference between ISO Class 5, 7 and 8?

ISO 14644 classification

The class number is a particle limit. The lower the number, the cleaner the room. Class 5 is where the critical work happens. Class 7 usually surrounds and supports it. Class 8 covers the background areas. Your process step decides the target. Full definitions on the ISO 14644 classification page.

ISO Class 5, 7 and 8 compared
ClassHow clean, side by sideWhere it is usually used
ISO Class 5Roughly 100 times cleaner than ISO Class 7Aseptic and other critical work
ISO Class 7Roughly 10 times cleaner than ISO Class 8The room that surrounds and supports the critical step
ISO Class 8The least strict of the threeLess-critical background areas

FIG. 03Comparative only. Full particle limits per cubic metre are on the classification page.

Question 03

What is cleanroom validation (DQ/IQ/OQ/PQ)?

Cleanroom validation and qualification

Validation is the documented proof that a room does what it was designed to do. It runs in four stages, set out below. We deliver the full validation dossier, with particle counts. HEPA integrity testing is part of it. Stage by stage on the cleanroom validation and qualification page.

The four stages of cleanroom validation
StageThe question it answers
Design Qualification (DQ)Does the design meet the requirement?
Installation Qualification (IQ)Was everything installed correctly?
Operational Qualification (OQ)Does it perform under working conditions?
Performance Qualification (PQ)Does the room hold over time? Proven with particle counts and HEPA integrity testing to ISO 14644.

FIG. 04DQ/IQ/OQ/PQ. Every project is handed over with the dossier.

Where the full answers live

Group 03 / 2 questions

Equipment

Most buyers do not want to chase five suppliers for the air units, the transfer hatches, the doors and the gowning airlocks, and then hope the pieces fit together on site.

10

Equipment pages, each with its own specification, standards and questions

Answer 01

What cleanroom equipment does Fabtech make?

We manufacture the core equipment ourselves. For the room: modular wall and ceiling systems, cleanroom doors. For the air: air-handling units, terminal HEPA housings, fan-filter units, laminar airflow units. For transfers and contained work: pass boxes, air showers, biosafety cabinets. Each is engineered for its room and qualified with it. See the cleanroom equipment page and the product pages.

Cleanroom equipment

Answer 02

Do you supply equipment standalone as well as turnkey?

Yes, both. We run turnkey cleanroom projects from design to validated handover. We also supply equipment standalone, whether you are extending a facility, replacing a unit, or fitting out a room someone else built. Same build, same specification either way. Browse the cleanroom equipment page or ask for a quote.

Ask for a quote

The list in the answer is the list we build. Modular wall and ceiling panels in PUF and Rockwool, air-handling units, terminal HEPA housings, fan-filter units, laminar airflow units, pass boxes, air showers, cleanroom doors and biosafety cabinets are made in our own facility. The rest of a fit-out, including laboratory fume hoods and epoxy flooring, is specified, supplied, installed and commissioned with the room. Every unit below has its own page.

Every unit, its own page

Each page carries the specification, the standards the unit is built and tested to, and the questions buyers actually ask about that unit. Sized for the room it serves, qualified with it, and covered by an equipment maintenance contract after handover.

The air standard we test to
ISO 14644-1
Stages in every validation dossier
DQ/IQ/OQ/PQ
Cleanroom projects delivered
2,000+
Group 04 / 3 questions

Process and delivery

A cleanroom project is long, and the worst version of it is the one where nobody owns the whole thing. When one engineering team carries it end to end, the room briefed in the first meeting is the room that passes on test day.

One partner is accountable for the whole scope. You brief the requirement and receive a qualified room. The scope runs from process and airflow design through modular construction, cleanroom HVAC and equipment, to a full validation dossier. One engineering team owns every stage. The turnkey cleanroom services page walks through it.

Turnkey cleanroom services

Where the full answers live

Group 05 / 3 questions

Commercial

Two questions come up in every first call. What will it cost, and what do you need from me.

No price is printed on this page, and none is printed anywhere on the site, because a cleanroom price without a scope is a number that misleads both sides. What is printed is what sets it, and exactly what we need from you to return a costed proposal.

  • How do I get a quote, and what do you need from me?

    Tell us three things to start: your industry, your process, and your floor area. Our engineers return a scoped proposal. It names the governing standard and your target ISO class or GMP grade. It sets out the validation plan. The more you share about your site, the tighter it comes back. Send it through the contact page.

    Send an enquiry

    Industry
    Pharmaceutical, biotech, semiconductor, electronics, solar, data centre, or food and beverage
    Process
    What happens in the room, and which step is the critical one
    Floor area
    Approximate square metres, and how many rooms
    Target class or grade
    If you know it. If not, our engineers set it from the process
    Site
    A bare shell, an extension, or a facility that is still running
    Timing
    When the room has to be qualified and in use

  • How much does a cleanroom cost?

    There is no single price. The cost is set by what the room has to do. An ISO Class 5 aseptic suite costs far more per square metre than an ISO Class 8 background area. We scope each project and return a costed proposal. Ask through the contact page.

    What sets a cleanroom cost
    Cost driverWhat it covers
    Cleanliness targetThe ISO class or EU-GMP grade your process needs
    Floor areaThe size of the facility
    Air and validation scopeThe HVAC and validation dossier the standard demands
    Starting pointA new build, or a retrofit into an existing shell

    FIG. 05Drivers only. Each project is scoped and returned as a costed proposal.

  • Where in India do you work?

    We work across India from our office in Mumbai, Maharashtra. Completed projects sit in several states. One team scopes and manages each project from Mumbai, so you deal with the same people wherever the facility sits. The registered office address and enquiry details are on the contact page.

    Contact and registered office

Where the full answers live

Still asking

Still have a question?

Questions about one product are answered on that product's own page. If your question is about a standard, the detailed pages carry it. If you are asking about a job or a role with us, the careers page is where that belongs.

For anything else, tell us your industry, your process and your floor area through the contact page. Our engineers will come back with a scoped proposal.

Enquiry routeThree things in, four things back
An enquiry route, stacked: the three things you send, an engineer scoping them, and the four things the proposal comes back with.WHAT YOU SENDYour industryYour processYour floor areaScoped by an engineerWHAT COMES BACKThe governing standardYour target ISO classor EU-GMP gradeThe validation planA costed scope

FIG. 06The enquiry route. Three things go in: your industry, your process and your floor area. An engineer scopes them, and the proposal comes back naming the governing standard, your target ISO class or EU-GMP grade, the validation plan and a costed scope. Nothing here needs a drawing or a site survey to begin.

Your questionThe page that owns it

Where each kind of question goes

Request a quote

Still not the answer you needed?

Send your industry, your process and your floor area. An engineer replies with a scoped proposal that names the governing standard and your target class.

Based in Andheri (West), Mumbai
Delivering cleanroom projects across India.

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