Cleanroom construction in Poland — turnkey ISO 5–8 controlled environments
A turnkey cleanroom project covers process design, enclosure construction, HVAC with HEPA filtration, automation and IQ/OQ/PQ validation. A typical ISO 7 cleanroom of 200–500 m² takes 12–20 weeks to deliver, with investment costs in the range of 3,500–8,000 PLN/m² (roughly 800–1,900 EUR/m²). Clima Line has been running such projects since 2013, with an engineering team of over 15 years’ experience.
For pharmaceutical, microelectronics, optics and automotive production, standard ventilation is not enough. Wherever a single dust particle threatens the whole process, you need a cleanroom — an environment with controlled particle concentration, temperature, humidity and pressure cascade.
Which cleanliness class do you need?
The most common mistake at the enquiry stage is choosing a class “with a margin”. Over-specifying by one class raises investment cost by 40–80% and annual running cost by as much as 150–300% — mainly through higher air change rates. Typical requirements by industry:
- Aseptic drug filling, implants — ISO 5 (GMP A/B), approx. 7,000–12,000 PLN/m²,
- pharmaceutical production, medical devices — ISO 7 (GMP C), approx. 4,500–8,000 PLN/m²,
- automotive: sensors, LiDAR, electronics, glazing — ISO 7–8, approx. 3,500–6,000 PLN/m²,
- optics and glass industry — ISO 7, approx. 4,000–7,000 PLN/m²,
- aseptic packaging, clean warehouses — ISO 8 (GMP D), approx. 2,500–4,500 PLN/m².
ISO 7 means no more than 352,000 particles ≥0.5 µm per m³ of air (EN ISO 14644-1).
What a turnkey delivery includes
- Process analysis and URS — class, temperature tolerance (±0.5°C), humidity (±5% RH) and pressure cascade derived from your technology, not from a catalogue.
- Pressure cascade and airlock design — personnel and material airlocks with door interlocks.
- Architectural enclosure — PIR/PUR sandwich panels, seamless resin floors, coved corners, hermetic doors, flush-mounted windows.
- Multi-stage filtration — pre-filters, fine filters and ceiling laminar modules with HEPA H13/H14 filters and a properly selected air change rate (ACH).
- Automation and monitoring — BMS integration with continuous parameter recording as evidence of class compliance.
- IQ/OQ/PQ validation — leak tests, particle counts, DOP/PAO filter integrity tests, full GMP-compliant qualification documentation.
Project stages and timeline
Weeks 1–2: process analysis and URS. We identify which operations genuinely require a clean zone, what tolerances follow from the process, and how people and materials will flow. Mistakes made here are the most expensive — they propagate through design, construction and qualification.
Weeks 3–6: process and detailed design. Heat and moisture balance, air change rates, pressure cascade with airlocks, AHU, chiller and filtration selection, controls design. The modular-vs-masonry decision is made here — modular construction shortens the build by 4–8 weeks.
Weeks 7–12: enclosure and installations. Panels, resin floors and hermetic doors in parallel with ductwork, chilled water piping and control wiring. For retrofits we schedule this stage around production windows — most of our conversions ran without stopping neighbouring production.
Weeks 13–16: commissioning, balancing and validation. AHU start-up, airflow balancing, cascade setting, then IQ/OQ/PQ: leak tests, particle counts at rest and in operation, DOP/PAO integrity testing. Handover includes complete documentation and trained personnel.
Why HVAC decides whether the investment succeeds
The cleanroom market is dominated by enclosure suppliers — panels, ceilings and doors. Yet HVAC is 50–60% of the investment budget, and it is HVAC that decides whether the room holds its class for ten years or starts losing it after the first season. The most common causes of failed validation that clients bring to us have nothing to do with panel quality: air change rate too low for full production load, no real pressure cascade, thermal bridges leading to condensation, and cooling plant with no reserve capacity for hot days.
Clima Line grew out of industrial refrigeration and process ventilation. We do the air design ourselves — from heat balance to AHU selection — which is why we take responsibility for the validation result, not just for the installation.
What you receive in the handover documentation
- as-built design documentation — HVAC, chilled water and controls diagrams matching the state after balancing,
- IQ/OQ/PQ qualification protocols — from installation verification to performance confirmation under production conditions,
- measurement reports — particle counts at rest and in operation, air change rates, pressure cascade, DOP/PAO filter integrity, recovery time,
- controls and BMS settings — setpoints, alarms, hystereses; everything needed to restore the validated state years later,
- equipment manuals and operating instructions — with inspection and filter replacement schedules,
- monitoring and requalification plan — per ISO 14644-2, as the basis for keeping the class in the years ahead.
Reference project: 400 m² ISO 7 for automotive
Our flagship recent delivery: an ISO 7 (class 10,000) zone for a new automotive production line, with minimum 15 Pa overpressure and 24/7 operation. Key figures: approx. 400 m² across several rooms with different pressure requirements, total airflow above 100,000 m³/h, absorption dehumidifiers rated 18,000 m³/h, an 800 kW chilled water plant with emergency by-pass and capacity reserve, final H14 filtration, pressure regime per EN ISO 14644.
In total we have delivered five cleanrooms exceeding 1,000 m² of combined area and around ten retrofits of existing zones — including ISO 8 to ISO 7 upgrades in operating plants. Our clients include Danone, Saint-Gobain, Mubea, Antolin and PGE.
Who is responsible for the design
The technology side of every project is led by Marcin Sompoliński, PhD Eng., co-owner of Clima Line and a specialist in HVAC design for controlled environments. The team counts 20 people across the design office and site work; we cooperate with academic staff of the Wrocław University of Science and Technology. We hold all licences required to design, build and operate the installations, which lets us run the investment under a single contract.
Working with international clients
We work for foreign-owned plants in Poland and deliver projects under NDA. Quality standards we operate in daily — IATF 16949 for automotive and EU GMP Annex 1 for sterile pharma — are structurally equivalent to AQAP requirements used in NATO supply chains. Project documentation can be produced in English.
Frequently asked questions
How long does cleanroom construction take?
For ISO 7 at 200–500 m², typically 12–20 weeks from detailed design approval. Modular construction shortens this by 4–8 weeks versus masonry.
How much does a cleanroom cost?
For ISO 7, roughly 3,500–8,000 PLN/m² (about 800–1,900 EUR/m²): HVAC 2,000–5,000 PLN/m², enclosure 800–2,000 PLN/m², plus automation and validation. The main cost driver is the air change rate, not the panels.
Can you build inside an operating plant?
Yes — we stage the works around production windows, with temporary barriers separating the construction zone from running production. Most of our retrofit projects were delivered without stopping the plant.
Do you provide validation and documentation?
Yes. IQ/OQ/PQ qualification, particle measurements, filter integrity tests and the full documentation package are part of the turnkey scope — including an English-language set for international audits.
Can the investment be phased?
Yes. Natural stages are: concept design, detailed design, enclosure with installations, validation. Area phasing is also possible — starting production in the first part of the zone while the rest is still being built — provided the pressure cascade is designed for the target layout from the start.
Planning a cleanroom project?
Send us your process description and hall layout — we will prepare a concept with air balance, proposed class and a quotation broken down into enclosure, HVAC, automation and validation. Call +48 32 450 56 66 or write to biuro@clima-line.pl.
Technical background
If you want to understand the engineering behind the decisions on this page, we wrote it up in detail: cleanroom construction step by step — a complete ISO 7 guide. For process-specific requirements in automotive: cleanrooms for the automotive industry. And a delivered project with real numbers: 400 m² ISO 7 case study.