Project · Pharmaceutical · Aurangabad
Ajanta Pharma, Aurangabad: a turnkey pharmaceutical cleanroom project
Fabtech delivered the oral-solids manufacturing cleanroom for Ajanta Pharma's Aurangabad facility, engineered to the ISO class and GMP grade its process demands, and handed over fully validated.
- One accountable team, from design to handover
- Design & Build
- Cleanroom HVAC
- Validation
- Grade C / D
- Class 7 / 8
Project summary
- Client
- Ajanta Pharma Ltd
- Location
- Aurangabad, Maharashtra, India
- Sector
- Pharmaceutical
- Facility type
- Oral solid dosage formulations
- Cleanroom class
- ISO 14644 Class 7 / 8
- GMP grade
- EU-GMP Grade C / D
- Scope delivered
- Design and build, cleanroom HVAC, validation
- Validation stages
- DQ, IQ, OQ and PQ (design, installation, operational and performance qualification)
- Floor area
- On request
- Rooms / zones
- On request
- Timeline
- On request
- Completion year
- On request
Inside the delivered cleanroom
Project photography from the Fabtech turnkey cleanroom at Ajanta Pharma, Aurangabad.
FIG. 01Project photography, Ajanta Pharma Aurangabad.
The challenge
Ajanta Pharma needed an oral-solids manufacturing environment at its Aurangabad site. It had to hold its conditions hour after hour, day after day, and stand up to inspection. The stakes are plain enough. In a drug plant, a room that fails its audit does not just cost a rebuild. It holds up the product behind it. The cleanroom is not a shell around the line. It is part of how the product is made safely, and a single weak point is exactly what an inspector finds: an air pressure that drifts, or a finish that traps residue. So Ajanta wanted one accountable company to design, build and prove the whole environment. The alternative was stitching together a separate designer, panel supplier, HVAC contractor and validation agency, then owning the gaps between them.
Why the regulatory target drives the engineering
The rooms had to classify to Class 7 and Class 8 and hold Grade C and D conditions. They also had to stand inspection under India's Schedule M and WHO-GMP. In practice that means four jobs done all day, every day. Hold airborne particles at the target class. Hold the pressure steps between process rooms, typically 10 to 15 Pa, so air always moves from cleaner rooms to less-clean ones. Hold temperature and humidity to the process tolerance. Then write all of it down, stage by stage, so the facility qualifies cleanly when the inspector walks in.
What Fabtech engineered
Fabtech delivered the project turnkey: one contract, one accountable team, from design through validated handover.
Design & build
An inspection-ready cleanroom laid out around how the product actually moves through the plant.
The layout zones people and material flows apart, with the mixed, non-unidirectional airflow an OSD facility uses. Finishes are coved and cleanable to GMP standard, and the as-built documents hand over with the room.
Cleanroom HVAC
The air system that holds each room to its grade and keeps the pressures right.
An AHU system with terminal HEPA filters, sized to the target grade. Filter grades H13 and H14 are confirmed at sign-off. Air changes are sized in ACPH, with temperature and humidity held to the process tolerance.
Equipment supplied
The in-room equipment for this facility is available on request.
We manufacture laminar air flow units, pass boxes, cleanroom doors and air showers in-house, and supply them where a project needs them.
Validation & qualification
We did not just build it. We proved it works, and handed over the proof.
The full qualification sequence, followed by the physical tests in the table below. Every check was run and written up before handover, as part of the scope above.
What we tested, and what each test proves
Every check below was run and written up before handover, as part of the validation scope above.
| Check we delivered | What it proves |
|---|---|
| DQ / IQ / OQ / PQ | Design, installation, operational and performance qualification, documented in sequence |
| HEPA integrity testing (PAO / DOP) | Terminal filters and their seals are leak-free |
| Airflow velocity and uniformity | Each room receives the air volume the design calls for |
| Pressure-differential mapping | The cascade between rooms holds as designed |
| Recovery studies | A room returns to its class after a disturbance |
| Particle-count certification | Counts meet the target class, tested to ISO 14644-1, -2 and -3 |
Standard qualification set for a classified pharmaceutical facility.
One contract, five stages, one accountable team
Fabtech delivered design, build, HVAC and validation in-house, so the gaps where multi-vendor projects fail never opened.
Design & DQ
ISO-class layout, airflow & pressure-cascade design
Build
In-house modular panels, GMP-compliant finishes
Cleanroom HVAC
AHU + terminal HEPA, pressure cascade
Validation
DQ/IQ/OQ/PQ, proven in stages to the target class and grade
Handover
Validated facility plus its qualification dossier; AMC covers supplied equipment only
How the pressure cascade keeps the room clean
A pharmaceutical cleanroom holds its grade by keeping air flowing from clean to less-clean and never the reverse. Positive pressure steps up toward the primary process room, typically 10 to 15 Pa between adjacent grades.
FIG. 02Air flows clean to less-clean, pressure rises toward the process core. Illustrative typical cascade.
Even two rooms of the same grade sit at different pressures. The dispensing room sits highest, because that is where open powder is handled. Air always moves from the cleaner room toward the less clean one, so particles travel out of the process rooms, never into them.
That is the whole point of a pressure cascade. The figures above show how an OSD cascade is staged. The values for this facility are confirmed on request.
Why an oral-solids cleanroom is built differently from a sterile one
Not every pharmaceutical cleanroom is the same room with a different label. An oral solid dosage plant makes tablets and capsules, the products Ajanta makes here. The product is never open to the air the way an injectable is. So the rooms run at Grade C and D, Class 7 and Class 8, not at the aseptic Grade A a sterile line needs.
There is no aseptic core here, and no unidirectional laminar airflow either. A sterile fill-finish line depends on both. An oral-solids plant does not. What it does need is just as demanding. Reliable particle control. A proven cascade between rooms, so nothing crosses from one product to another. And tight humidity control, because many oral-solid formulations are moisture sensitive.
Designing to the actual process is the difference between a facility that qualifies cleanly and one that fights its own audit. We do not over-build to a sterile spec, and we do not under-build either.
Delivered turnkey, handed over validated
Fabtech designed, built and validated the cleanroom for Ajanta Pharma's Aurangabad plant as a single turnkey project, and handed it over with its qualification dossier. The specific performance figures for this facility, its area, timeline, audit outcome and any capacity result, are available on request, subject to the client's disclosure permissions.
If you are planning an oral-solids or other GMP facility, the fastest way to start is simple. Tell us the grade and footprint you need.
More cleanrooms we have delivered
Frequently asked questions
Fabtech delivered a turnkey pharmaceutical cleanroom for Ajanta Pharma's Aurangabad facility. The scope covered design and build, cleanroom HVAC, and full validation. The rooms serve oral solid dosage manufacturing, classified to Class 7 and Class 8 and holding Grade C and D conditions.
No. It is an oral solid dosage plant making tablets and capsules, so it runs at Grade C and D rather than the aseptic Grade A a sterile injectable line needs. There is no aseptic core and no laminar airflow. Particle control, room pressures and humidity control do that work instead.
The facility is classified to ISO 14644 Class 7 and 8. It holds EU-GMP Grade C and D conditions. It was built to stand inspection under India's Schedule M and WHO-GMP.
Those figures are available on request, subject to Ajanta Pharma's disclosure permissions. We publish project numbers only once the client has cleared them. What we can confirm today: a turnkey oral-solids cleanroom, designed, built and validated by Fabtech end to end.
Even two rooms of the same grade sit at different pressures. The dispensing room sits highest, because that is where open powder is handled. Air always moves from the cleaner room toward the less clean one, so particles travel out of the process rooms, never into them.
Yes. We design, build, air-handle and validate pharmaceutical cleanrooms across India, from oral-solids plants like Ajanta's to sterile, higher-grade lines.
Planning a pharmaceutical cleanroom?
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