ServiceA-02.02
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.
Engineering approach
How we work on this
The order matters more than any individual decision in it. Most of the failures we are called in to correct are sequencing failures rather than equipment failures.
- 01
The class decides the room
ISO 14644-1 classifies a room by permitted airborne particle concentration, not by air-change rate directly. Fixing the target class first is what sets filtration coverage, air-change rate and the pressure relationships between adjoining spaces.
- 02
The cascade is the design
Every classified space holds a positive differential against the less clean space beside it, so leakage only ever travels clean to dirty. Airlocks, gowning and material transfer routes are laid out to make that cascade continuous rather than to fit a floor plan.
- 03
Built to be tested
Filter housings, test ports, damper positions and access routes are placed so that the room can be integrity-tested and rebalanced later. A room that cannot be re-tested cannot be kept qualified.
Scope of workA-02.02
Everything carried under this discipline
Not a summary. If it is on this list we carry it ourselves rather than subcontracting it.
- 02.01Modular cleanrooms
- 02.02PUF/Rockwool partitions
- 02.03Cleanroom ceilings
- 02.04HEPA filtration
- 02.05Pass boxes
- 02.06Airlocks
- 02.07Pressure cascade
- 02.08Laminar airflow systems
- 02.09Cleanroom doors & windows
- 02.10Epoxy flooring
Deliverables
What you are holding at the end
The documents that make the next stage of your project possible, and that an auditor will ask to see.
- Cleanroom layout with classification and pressure zones
- Partition, ceiling and flooring specification
- Filtration schedule with grade and coverage
- Airlock, pass box and material flow arrangement
- Handover documentation for the qualification package
Relevant standards
What the work is designed and tested to
- ISO 14644-1
- Cleanroom classification by airborne particle count
- WHO-GMP
- Good manufacturing practice for pharmaceutical premises
- USFDA
- US requirements for drug manufacturing facilities
Typical applications
Where this work goes
- Pharmaceutical formulation, filling and packing suites
- Sterile and aseptic processing areas
- Biotech and laboratory clean areas
- Medical device and electronics clean assembly
Proof
Work of this kind
Most of our work is carried out under confidentiality agreements with pharmaceutical manufacturers and hospitals, so it is not published here. Reference contacts for comparable facilities are provided on request during a tender.
Questions
What people ask us first
- What ISO class do I need?
- It follows from the product and the process step, not from preference. Aseptic filling, terminal sterilisation, secondary packing and QC laboratories all carry different requirements, and the applicable GMP text is usually explicit about it. Tell us the process and we will tell you what the room has to hold.
- Can you work inside an existing building?
- Yes. Most cleanroom work is a fit-out inside an existing shell. The constraints are usually available height for the ceiling void, plant space, and whether the structure can carry the AHU.
- Does turnkey include the HVAC?
- Yes. The enclosure and the air system are one design problem (the panels exist to hold the air in a specified condition), so they are scoped and delivered together.