Bio-pharmaceutical cleanroom manufacturer
Pharmaceutical cleanrooms and GMP HVAC, built to pass inspection the first time
One partner takes your facility from grade target to a validated, inspection-ready environment: cleanroom, HVAC and the dossier together.
- 2,000+ controlled environments, any sector, since 2004
- EU-GMP Grade A to D
- ISO Class 5 to 8
- Revised Schedule M & EU-GMP Annex 1
- Cleanroom + HVAC + validation, one team
- In-house manufacturing
What a pharmaceutical cleanroom is
A pharmaceutical cleanroom is a controlled space where the air, the pressure, the temperature and the humidity are engineered and continuously watched, so medicines are made without contamination. Every room is classified to ISO 14644 and EU-GMP Grade A to D.
In India it is built to the revised Schedule M, then proven step by step before the first batch runs.
Fabtech Cleanrooms is an Indian bio-pharmaceutical cleanroom and HVAC manufacturer. We design, manufacture, install and validate GMP cleanrooms for India's drug and biologics makers.
Why a pharmaceutical cleanroom is unforgiving
In a drug facility the cleanroom is not a building wrapped around the line. It is part of the product. Get the air, the pressures or the surfaces wrong and the batch is at risk. So is the inspection that decides whether you can sell it.
The failures are rarely dramatic. A filter that drifts. A pressure step nobody properly proved. A finish that quietly traps dirt. We engineer those failure modes out, then prove on record that they are out. That is where pharma cleanroom consulting earns its keep.
We translate your process and your regulator's target into a buildable, inspection-ready design. That means clean flows for people and materials, and a proven pressure cascade between rooms. It means air sized to the grade, with laminar flow over the critical core. It also means a written Contamination Control Strategy (CCS), aligned to Annex 1 and the revised Schedule M. One accountable team carries the whole file, the single-point ownership a crore-scale regulated build demands. The dossier and the build never split across vendors.
FIG. 01Three ways a compliant-looking room quietly fails: a HEPA leak only an integrity scan finds, a pressure step that reverses because nobody proved it, and a square joint that traps what a coved skirting sheds. We engineer these out, then prove on record that they are out.
How a pharmaceutical cleanroom is classified
Pharma is the only sector where each step of making the drug is mapped to a regulatory grade. That mapping decides the design before any equipment is chosen. The same room also carries two particle limits. One applies at rest: built, running, nobody inside. The other applies in operation: people working, line live. This table is the single reference an Indian QA or projects lead can lift to brief a facility:
| EU-GMP grade | ISO class (at rest / in op.) | Max 0.5 um/m3 at rest | Max 0.5 um/m3 in operation | Pressure vs lower grade | Where it applies |
|---|---|---|---|---|---|
| Grade A | ISO 5 / ISO 5 | 3,520 | 3,520 | +10 to 15 Pa | Aseptic core, sterile fill-finish, open product, LAF zones |
| Grade B | ISO 5 / ISO 7 | 3,520 | 352,000 | +10 to 15 Pa | Background to the aseptic core; gowning to Grade A |
| Grade C | ISO 7 / ISO 8 | 352,000 | 3,520,000 | +10 to 15 Pa | Preparation, compounding, less critical processing |
| Grade D | ISO 8 / not defined in op. | 3,520,000 | not defined by EU-GMP | +10 to 15 Pa | Oral solids, secondary packing, general GMP, gowning |
FIG. 02The limits are published EU-GMP Annex 1 and ISO 14644-1 values, not ours.
The riskier the moment in making the drug, the cleaner the air has to be. Filling an open vial of injectable needs the cleanest air there is. Pressing tablets or boxing them sits far down the scale. The two columns matter because a room must hold its class with people working and the line live, not just sitting empty on handover day.
The Schedule M angle (India-specific)
India rewrote its GMP rulebook. The revised Schedule M was notified in December 2023 and phased in through 2024-25. It pulls Indian facilities toward the same discipline as Annex 1: a formal quality system, a written contamination control strategy, qualified utilities, and rooms proven in operation, not just at rest. We design every Indian pharma facility to the revised Schedule M from the URS onward. The room that passes on paper is the one an inspector sees.
Different regulators walk the same corridors with different checklists. The room is designed and built to withstand inspection under all of them: India's revised Schedule M and WHO-GMP, the revised EU-GMP Annex 1 (Grade A to D), and ISO 14644-1/-2/-3. Where a facility manufactures for export, we engineer to the controls a US FDA, MHRA or TGA inspection expects. If an older specification still quotes the Federal Standard 209E "Class 100 / 1,000 / 10,000" ratings, note that 209E was withdrawn and superseded by ISO 14644 in 2001. We map any such legacy spec onto the current ISO classes.
What a pharmaceutical cleanroom must deliver
Six systems decide whether the room holds its grade, year after year. Here is what each one looks like from the corridor, and the engineering underneath it.
- 01
Unidirectional Grade A core
The critical zone where product is exposed, engineered for the cleanest achievable air.
ISO Class 5, unidirectional (laminar / LAF) airflow, Grade A at rest and in operation, continuous 0.5 um and 5.0 um particle monitoring, terminal HEPA H14, positive to the surrounding Grade B, smoke-study proven.
- 02
Engineered HVAC and air changes
The system that holds the class 24/7 at sane running cost.
AHU and MAU sizing, Air Changes per Hour (ACPH/ACH) matched to grade; classified rooms typically 20 to 60+ ACPH; Grade A unidirectional flow to the legacy ~0.45 m/s +/-20% guideline (current EU-GMP Annex 1 requires a justified, qualified velocity); temperature and relative-humidity control; VFD and heat-recovery options to cut a facility's largest lifetime energy cost.
- 03
Terminal HEPA / ULPA filtration
The filters that make the air clean.
Terminal HEPA H13/H14 (>=99.95% / >=99.995% at MPPS, EN 1822), ULPA U15 to U17 where the most critical zones demand it, integrity-tested by PAO/DOP at handover and on schedule.
- 04
Pressure cascade and containment
Air always flows from clean to less clean, never the reverse.
Mapped differential cascade, typically 10 to 15 Pa between grades; airlocks and pass-throughs; negative-pressure containment options for potent, cytotoxic or sensitising compounds.
- 05
GMP-cleanable construction
Surfaces that do not trap contamination and survive daily cleaning.
Modular wall and ceiling panels; PUF and Rockwool infill manufactured in-house; honeycomb infill supplied when a project specifies it; flush glazing, coved skirting, walkable ceilings; seamless coved epoxy/PU flooring with no particle-trapping joints.
- 06
Monitoring and controls
The room watches itself and logs the proof.
BMS/SCADA for temperature, RH, pressure differentials and particle counts, with alarms and audit-trail data for review.
- Controlled environments
- 2,000+
- Delivering since
- 2004
- Sector that needs controlled air
- Any
- EU-GMP grades built
- A to D
- ISO 14644 classes held
- ISO 5 to 8
HVAC in the pharmaceutical industry
Ask any plant head what actually holds a cleanroom to its grade and the honest answer is the air system. HVAC in the pharmaceutical industry is not air conditioning for comfort. It is the engine that creates the cleanliness, the pressure and the humidity the medicine needs, every hour the line runs. It is the part most often under-designed, and the part inspectors scrutinise hardest. We design and build the HVAC with the cleanroom, as one turnkey pharma HVAC scope. The air strategy that passes on paper is the one that gets installed. Get the air right and everything else about the room gets easier.
The system is built around the air handling unit (AHU) and the make-up air unit (MAU). Terminal HEPA filters clean the supply air. Ducting, dampers and controls hold each room positive, or negative for containment, against its neighbour. We size the air changes to the grade the room must hold. The whole design is then proven during OQ and PQ. Two demands sit at the edge of this discipline. Vaccine manufacturing, where vaccine HVAC, cold-chain, humidity and containment all bear on the air design, is its own engineering problem. Stem-cell production needs tight HVAC control of temperature, humidity and particulate, or the cells are lost. As one of India's HVAC systems manufacturers for the pharma industry, we engineer for both.
FIG. 03The differential cascade the air system holds: each grade sits 10 to 15 Pa above its less clean neighbour, so air always leaves the cleanest room and never returns. The cascade is mapped during design and proven by pressure mapping in OQ and PQ.
Pharmaceutical applications we engineer for
Every process below carries its own cleanliness grade, pressure regime and finish. So we engineer the whole facility around the work you actually run, not a generic template. The table groups the applications we build for; each one is its own discipline, with its own air behind it.
| Stage of the work | Applications we engineer for |
|---|---|
| Making the product | drug manufacturing · API production · biologics production · sterile and aseptic fill-finish · oral solid dosage (OSD) |
| Biological and advanced therapies | cell culture · vaccine manufacturing · gene therapy · stem cell production · protein purification |
| Proving and protecting it | sterilization · quality control · microbiology and QC laboratories · clinical trials · R&D and clinical-trial material |
| Packing and dispatch | primary and secondary packaging |
Work that crosses into biologics containment (BSL-2/BSL-3) is engineered in concert with our biotech cleanroom and BSL containment team.
Pharmaceutical room types we build
- Aseptic fill-finish and sterile cores (Grade A in B)
- oral solid dosage (OSD) suites
- API and intermediate plants
- biologics and bio-pharmaceutical suites
- QC and microbiology laboratories
- packaging and warehousing to grade
- change rooms, airlocks and material/personnel flow
We supply these as modular cleanroom solutions sized to the grade. Each room type carries its own class, pressure regime and finish. The whole is designed as one integrated facility, not a set of suites bolted together.
How we deliver a validated pharmaceutical cleanroom
One accountable team, six stages, each closing with a record an auditor can read. We bring the cleanroom design, the HVAC and the validation consulting a pharma project needs under one roof, as turnkey cleanroom solutions. Nothing falls between vendors.
- 01
Requirement capture (URS)
We capture your process, your regulatory target, your flows and your utilities, and we survey the site. Scope, programme and cost are framed here. Deliverable: signed-off URS.
- 02
Design & Design Qualification (DQ)
Layout, flows, pressure steps and equipment are proven on paper against the brief before anything is bought. Deliverable: GA designs, airflow and pressure schematics, DQ.
- 03
Manufacture & Factory Acceptance Testing (FAT)
Panels, ceilings, LAF units, pass boxes and doors are built in our own facility and tested before dispatch. The tests cover the equipment, not the installed room. Deliverable: FAT records.
- 04
Installation & Installation Qualification (IQ)
Panels, ceilings, flooring, HVAC, terminal filters, controls and utilities go in exactly as designed, and the record proves it. Deliverable: IQ protocol and report.
- 05
Commission, validate & qualify (OQ/PQ)
The room is pushed to prove itself: filter integrity, airflow velocity and uniformity, pressure mapping, recovery studies and certified particle counts. Smoke studies prove the airflow wherever it must move one way. Deliverable: OQ and PQ reports, plus the classification certificate.
- 06
Handover
You receive the as-built designs, the full qualification dossier and operator training. The facility is then yours to run. Our equipment AMC keeps the HEPA, LAF and HVAC we supplied qualified. Deliverable: handover dossier, training records, AMC schedule.
FIG. 04One clock, six stages, looping. The top track is your facility taking physical shape, from surveyed plot to validated suite. The bottom track is the dossier your inspector reads, and it only accumulates: the stage that changes the room files the record that proves it. At rest the figure shows the finished state, room complete and file complete, because they are the same object.
What we manufacture in-house
The room and the equipment inside it come from the same factory and the same engineering team. Modular wall and ceiling systems. Air-handling units (AHUs). Flush doors and view panels. Laminar air flow (LAF) units. Biosafety cabinets. Pass boxes: static, dynamic and VHP. Air showers. Terminal HEPA housings and fan-filter units (FFUs). Building the equipment and the room under one roof is why the design that holds your class is the design that gets installed.
A validated GMP cleanroom, built and qualified by Fabtech.
Validation, documentation and compliance
Everything the room claims is proven in four steps and filed in one audit-ready dossier: design, installation, operation, performance. DQ/IQ/OQ/PQ. The file holds the filter integrity tests, the airflow visualisation, the recovery studies, the pressure map, the certified particle counts and the environmental-monitoring baselines. It is built around the revised Schedule M, the revised Annex 1 and the Contamination Control Strategy your inspector will ask to read, and aligned to the international classification standards.
Delivered pharmaceutical cleanrooms
As a bio-pharmaceutical cleanroom manufacturer, our reference work spans India's regulated drug and biologics makers. The exact classification and scope of each site is available on request.
- Ajanta Pharma, AurangabadGMP oral-solids facility, delivered & validated
- Desano, BangalorePharmaceutical cleanroom project
- Fresenius KabiPharmaceutical cleanroom project
Why Fabtech for a pharmaceutical cleanroom
- One party on the hookAs a bio-pharmaceutical cleanroom manufacturer we deliver the design, the manufacture, the HVAC and the validation under one team, so one accountable party carries your build end to end. The governance behind it is on the public record if your procurement team wants to check it.
- In-house manufactureWe make the panels and the equipment in-house.
- Inspection-readyWe hand over documentation written to withstand inspection.
Pharmaceutical cleanrooms, common questions
A sealed, controlled room where the air, the pressure, the temperature and the humidity are engineered and continuously watched, so medicines are made without contamination. Each room carries an international cleanliness class and a GMP grade, and in India is built to the revised Schedule M.
The air system that creates and holds a cleanroom's cleanliness: filtered air, controlled pressure between rooms, and tight temperature and humidity. It decides whether a room holds its grade. That is why a pharma HVAC manufacturer designs the air system with the room, not after it.
It depends on the step. Aseptic fill-finish needs the cleanest air, Grade A, ISO Class 5. Background and preparation rooms sit in the middle grades. Oral solids and packing sit at Grade D, ISO Class 8. The room must hold its grade in operation, not just at rest.
Design, Installation, Operational and Performance Qualification. Design proves the concept on paper. Installation proves the build. Operational and Performance prove the running room. We deliver all four as one documented package, with filter integrity tests and certified particle counts.
Schedule M is India's drug-GMP standard. The revision, notified in December 2023 and phased in through 2024-25, moves India toward European practice: a written quality system, a contamination control strategy, and rooms proven in operation. We design every Indian pharma facility to it from day one.
Yes. Vaccine plants add cold-chain, humidity and containment demands to the air design. Stem-cell work needs tight control of temperature, humidity and particles for cells to stay viable. We engineer the cleanroom HVAC and the pressure regime around those constraints, then prove them before handover.
Yes. We build bio-pharmaceutical suites for biologics, cell culture, protein purification and gene therapy, delivered as modular cleanroom solutions. Where the work needs BSL-2 or BSL-3 containment, we engineer it together with our biotech cleanroom team.
Yes. For potent, cytotoxic or sensitising compounds we build negative-pressure containment with airlocks and dedicated air handling. For sterile manufacturing we deliver the room finishes and the pressure regime the process requires.
The project ends in a handover, and running the facility is then yours. Our equipment AMC keeps the systems we supplied, HEPA, LAF and HVAC, performing and requalified so the room keeps holding its class.
Planning a pharmaceutical cleanroom?
Share your process, grade target and floor area. Our engineers respond with a scoped proposal: grade target, air strategy and a validation plan.