Industry
HVAC and cleanrooms for pharmaceutical and biotech facilities
Classified suites where the air is a process parameter: particle count, pressure cascade, filtration and the qualification package that proves all three.
The problem
What has to be controlled, and what usually goes wrong
Every one of these is a design decision rather than a commissioning adjustment, which is why they are settled before anything is ordered.
- 01
Classification that matches the process step
The ISO class a room needs follows from what happens in it. Aseptic filling, terminal sterilisation, secondary packing and QC laboratories carry different requirements, and getting the class wrong at design stage shows up as a filtration retrofit after performance qualification fails.
- 02
A cascade that stays continuous
Every classified space must hold a positive differential against the less clean space next to it, through airlocks, gowning and material transfer. A cascade that inverts anywhere in the chain (usually at a loaded filter or a hardened door seal) stops the room being a cleanroom whatever its filtration says.
- 03
Cross-contamination between products
Shared air paths between suites handling different products are a GMP finding waiting to happen. Zoning, dedicated AHUs and exhaust arrangement are design decisions, not commissioning adjustments.
- 04
Documentation an auditor will accept
IQ, OQ and PQ have to run in order, each closing before the next opens, with every reading recorded against a location, an instrument and a date. A performance result on an installation that was never formally verified cannot be defended.
Spaces
What we are asked to build
- Formulation and granulation suites
- Sterile and aseptic filling areas
- Packing halls and secondary packing
- Quality control and microbiology laboratories
- Warehousing with controlled conditions
- Gowning, airlocks and material transfer
Standards
What governs the work here
- ISO 14644-1
- Cleanroom classification by airborne particle count
- WHO-GMP
- Good manufacturing practice for pharmaceutical premises
- USFDA
- US requirements for drug manufacturing facilities
Services
What we deliver for pharmaceutical & biotech
Usually more than one of these on a single project, which is the reason they are delivered under one contract rather than tendered separately.
- 02
Turnkey Cleanrooms
Modular cleanroom enclosures, HEPA filtration and pressure zoning built as one package, from partitions and ceilings to the airlocks that hold the cascade.
Explore service - 01
HVAC Design & Heat Load Calculations
Air-conditioning and ventilation systems sized from a calculated load rather than from a catalogue, through to equipment selection and duct design.
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Testing & Qualification
The measurements that prove a room performs: HEPA integrity, velocity, air changes, differential pressure and the IQ/OQ/PQ documentation behind them.
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AMC & Energy Retrofit
Maintenance built to keep a room in its qualified state, plus audits and retrofit work on systems that are running but no longer performing.
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