Process design
URS, ISO class 5–8, layout of zones and airlocks, flow of people and materials, air and heat balance.
ISO 5–8 CLEANROOM CONSTRUCTION / TURNKEY CLEANROOMS
Clean space.
Precise process.
Process design, enclosure, HVAC with HEPA filtration, automation and IQ/OQ/PQ validation. We build a 200–500 m² ISO 7 cleanroom in 12–20 weeks; the cost is 6 000–20 000 PLN/m² depending on class and scope. Five of our completed zones exceed 1 000 m².
- Cleanliness class
- ISO 5–8 per PN-EN ISO 14644-1
- ISO 7 limit
- ≤ 352 000 particles ≥ 0.5 µm/m³
- Air change rate
- 30–60 air changes/h
- Pressure cascade
- 10–15 Pa
- Lead time
- 12–20 weeks for 200–500 m²
- Cost by class and scope
- 6 000–20 000 PLN/m²
ONE PARTNER. ONE COHERENT SYSTEM.
Not just walls.
Conditions for work.
Air cleanliness, temperature, humidity and a 10–15 Pa pressure cascade have to be met in the finished facility, not in the calculations. That is why we design the zone as a whole: from the ISO class dictated by the process to the way it is operated day to day and revalidated periodically.
Enclosure and HVAC
Panels and ceilings, air handling units with HEPA H13/H14 filtration, 30–60 air changes per hour, chiller, dehumidification.
Automation
Pressure cascade with airlock interlocks, continuous logging of °C / % RH / Pa and particle counts, alarms and trend logging in the BMS.
Qualification
Particle counts at rest and in operation, DOP/PAO and leak tests, IQ/OQ/PQ protocols and a monitoring plan to ISO 14644-2.
FROM BRIEF TO HANDOVER
A good result
starts
with the process.
Every stage follows from the previous one. From the start it is clear what we are designing, which parameters we will check at handover and how we will document them.
- 01
Understand the process.
We start with the production technology and the zone requirements. We define the flow of people and materials, the cleanliness class and the air parameters.
- 02
Design it as one.
We combine the enclosure, HVAC installations and automation into one system. We match the solution to the process and to what the building allows.
- 03
Build and commission.
We coordinate construction, installation and balancing of the systems. We check that all equipment works together before the zone is handed over for use.
- 04
Confirm the parameters.
Measurements and documentation close the delivery stage. We also agree the scope of later inspections and maintenance of the installation.
REQUIREMENT → PARAMETER → DELIVERY → PROOF
ISO class
on paper and on the floor.
This is how we translate process requirements into installation parameters and documents that your customer’s auditor or a GMP inspection will accept.
| Requirement | Parameter | How we deliver | How we prove it |
|---|---|---|---|
| ISO 7 cleanliness class | ≤ 352 000 particles ≥ 0.5 µm/m³ (PN-EN ISO 14644-1) | 30–60 air changes/h, multi-stage filtration ending with HEPA H13/H14 | Particle counts at rest and in operation, PQ report |
| Pressure cascade | 10–15 Pa; in automotive min. 15 Pa overpressure | Airlocks with door interlocks, damper adjustment, BMS supervision | Continuous differential pressure logging with alarms |
| Temperature and humidity | ±0.5 °C and ±5% RH per URS | Heat balance, chiller with reserve capacity, absorption dehumidifiers | BMS trend and stability test in PQ |
| Terminal filter integrity | HEPA H13/H14 in ceiling modules | Pre-filters, fine filters, terminal filters in supply diffusers | DOP/PAO test at handover and every 12 months |
| Documentation for a GMP audit | IQ/OQ/PQ, monitoring plan per ISO 14644-2 | Measurements and settings recorded after balancing | Full set of qualification protocols and measurement reports |
Cleanliness classification per PN-EN ISO 14644-1, monitoring and requalification per PN-EN ISO 14644-2. Sterile manufacturing: EU GMP Annex 1, revision of August 2022, applicable from 25 August 2023.Legal status: September 2026
Which cleanliness class does my process require?
The cleanliness class follows from the process, not from a catalogue: over-specifying by one class raises investment cost by 40–80% and annual running cost by 150–300%. Aseptic drug filling and implants require ISO 5 (GMP A/B). That is the upper end of the price range, up to 20 000 PLN/m². Pharmaceutical production and medical devices operate in ISO 7 (GMP C). Automotive (sensors, LiDAR, electronics, glazing) fits within ISO 7–8, at the lower end of the range, from 6 000 PLN/m². ISO 5–6 also covers microelectronics and processes under laminar flow: laminar flow modules over workstations, much higher airflows and usually online particle monitoring.
Optics and the glass industry require ISO 7, while electronics assembly, medical device packaging, aseptic packaging, clean warehouses and buffer zones around cleaner areas need ISO 8 (GMP D) at 15–25 air changes/h, which means the smallest air handling units (AHU) and the lowest running costs. ISO 7 means a maximum of 352 000 particles ≥ 0.5 µm per m³ of air per PN-EN ISO 14644-1. Most industrial applications are fully served by ISO 7; we handle critical zones with ISO 5 islands inside an ISO 7 background.
How does delivery work and how long does it take?
An ISO 7 cleanroom of 200–500 m² is completed in 12–20 weeks from approval of the detailed design. Weeks 1–2 cover process analysis and the URS, the reference point for the design and later validation; mistakes at this stage are the most expensive. Weeks 3–6 cover process and detailed design: heat and moisture balance, air change rates, pressure cascade, selection of AHUs, chiller, filtration and controls. This is when the decision is made: modular or masonry. Modular construction shortens the build by 4–8 weeks.
Weeks 7–12 cover the enclosure and installations: PIR/PUR sandwich panels with coved corners, flush-mounted windows, seamless resin floors, hermetic doors, and personnel and material airlocks with interlocks, in parallel with ductwork, chilled water piping and controls. Weeks 13–16 cover commissioning, airflow balancing, setting the pressure cascade and IQ/OQ/PQ qualification with particle counts at rest and in operation. We hand over the zone with complete documentation and trained staff.
Why does HVAC decide the validation result?
The cleanroom market in Poland is dominated by enclosure suppliers (panels, ceilings and doors), yet the HVAC installation accounts for 50–60% of a cleanroom budget, and it is HVAC that decides whether the zone holds its class for ten years. The most common causes of failed validation have nothing to do with panels: an air change rate too low at full load, no real pressure cascade when doors open, thermal bridges with condensation and microbial growth on walls, and a cooling system without reserve on hot days. Clima Line grew out of industrial refrigeration and process ventilation. We do the air design ourselves, from the heat balance to AHU selection.
A reference project shows the scale: 400 m² of ISO 7 (Clean Room 10 000) for a new automotive production line, divided into rooms with different pressure requirements, with a minimum overpressure of 15 Pa and continuous 24/7 operation under variable loads. Total airflow exceeds 100 000 m³/h, the absorption dehumidifiers are rated at 18 000 m³/h, and the 800 kW chiller runs with an emergency by-pass and capacity reserve for line expansion. H14 final filtration, overpressure system compliant with PN-EN ISO 14644.
Can an existing zone be upgraded instead of building from scratch?
The typical reason for an upgrade is a zone that no longer holds its class, fails requalification, or has to move from ISO 8 to ISO 7 because the process or the end customer’s requirements have changed. An upgrade starts with measurements: air change rates, pressure cascade, filter integrity and enclosure tightness. Usually part of the infrastructure stays: replacing AHUs or adding a filtration stage is enough, and the cost is a fraction of a new build. We carry out the works in stages during shutdown windows, with temporary barriers between the work area and live production; the typical scenario is raising the class from ISO 8 to ISO 7.
Our track record includes 5 cleanrooms larger than 1 000 m² and hundreds of upgrades and service jobs in operating facilities, including the HVAC system for a Regional Blood Donation and Haemotherapy Centre and environmental control for lamination and screen printing of automotive glass. In total that is more than 100 HVAC projects, for clients including Danone, Saint-Gobain, Mubea, Antolin and PGE.
What does it cost to run a cleanroom, and what does the as-built documentation include?
A cleanroom costs twice: once at construction and every month on the energy bill. At 30–60 air changes per hour the AHUs run non-stop, and every excess air change carries a cost through the entire operating life. In the design we make sure the class is derived from the process, the AHUs have heat recovery and the controls reduce airflow in at rest mode outside production hours. The difference between a zone sized for the process and an oversized one reaches several tens of per cent of annual energy costs.
The complete handover documentation includes as-built diagrams for HVAC, chilled water and controls, IQ/OQ/PQ protocols, measurement reports (particles at rest and in operation, air change rates, cascade, DOP/PAO tests, zone recovery time), controls and BMS settings (setpoints, alarms, hystereses; they allow the state on the day of validation to be restored), equipment operation and maintenance manuals (DTR) with operating instructions, an inspection and filter replacement schedule, and a monitoring and requalification plan per ISO 14644-2. Without this set the zone will not pass a customer or notified body audit; the same set is the starting point for a service contract.
SEE HOW IT WORKS IN PRACTICE
BEFORE THE FIRST CONVERSATION
Good to
know.
How long does it take to build a cleanroom?+
For ISO 7 of 200–500 m², typically 12–20 weeks from approval of the detailed design. Modular construction shortens this by 4–8 weeks compared with masonry.
How much does it cost to build a cleanroom?+
Approximately 6 000–20 000 PLN/m², depending on the ISO class (ISO 8 at the bottom of the range, ISO 5 with GMP A/B at the top), floor area and scope: enclosure, HVAC with filtration, controls, validation. The largest item is HVAC with filtration. An exact quote requires an analysis of the production process.
How does an ISO class differ from a GMP grade?+
ISO 14644-1 classifies particle concentration only. GMP Annex 1 adds microbiological requirements and distinguishes the at rest state from in operation. GMP grade C corresponds approximately to ISO 7 at rest and ISO 8 in operation.
How do I prepare a request for quotation?+
We need 4 things: a description of the process, a hall layout with height and space for installation routes, formal requirements (GMP, IATF, external audit, end customer requirements) and a timeframe, including whether shutdown windows are an option. If the requirements are not final yet, we help define them before quoting. In return you receive a concept with the zone layout, air balance, class, schedule and a quote broken down into enclosure, HVAC, controls and validation; the first conversation is a free consultation.
What do the warranty and class maintenance after handover cover?+
Beyond the warranty on the installations we offer a service contract: inspections of AHUs and chillers, monitoring of pressure drops across HEPA filters, DOP/PAO integrity tests every 12 months and requalification according to the monitoring plan. The most common cause of losing class is dampers going out of adjustment after changes in the zone, not a worn filter. That is why every intervention in the system ends with a measurement, not a visual check.
Do you do the design only, without construction?+
Yes. A concept or detailed design can be a separate order: you receive documentation for a tender among contractors, including us. We also design under supervision, as technical support for the investor when a general contractor delivers the project. This arrangement is often required in larger organisations, where designer and contractor must be separate.
Do you take over zones built by other companies and build in operating plants?+
Yes. A takeover starts with an audit: measurements of air change rates, pressure cascade, filter integrity and a documentation review; the audit result tells us what to repair, what to adjust and what to leave. Missing as-built documentation does not block a takeover: we reconstruct the settings by measurement, which takes longer. In operating plants we have completed hundreds of upgrades and service jobs; we carry out the works in shutdown windows, usually without stopping neighbouring production.
Can the investment be split into stages?+
Yes, and for larger zones we recommend it. Natural cut points: concept design, detailed design, enclosure with installations, validation. A concept design ordered separately is also a document against which contractor offers can be compared. Another option is phasing the floor area: the first part of the zone starts operating while the rest is under construction. The pressure cascade must then be designed from the start for the final layout, so the decision has to be made before the detailed design.
Which industries do you build cleanrooms for?+
Most often for automotive, pharmaceuticals and the defence industry; the sectors differ not in ISO class but in the requirements around it. In automotive, particle cleanliness and fume control during lamination and screen printing of glass are decisive. In pharmaceuticals GMP comes on top: IQ/OQ/PQ qualification, monitoring with an audit trail and Annex 1 requirements. In the defence industry the technology is close to automotive, but we run the project under NDA, with controlled access to documentation and the site. We also build zones for microelectronics and optics.
Which class should I choose if I am not sure?+
We start with process analysis and the URS. Most industrial applications are fully served by ISO 7, and we handle critical zones with ISO 5 laminar flow modules inside an ISO 7 background. That is far cheaper than raising the class of the entire room.
Do you provide validation and documentation?+
Yes, full IQ/OQ/PQ qualification with documentation compliant with PN-EN ISO 14644 and GMP requirements, and after handover, service and periodic validation per ISO 14644-2.
Who is responsible for the design at Clima Line?+
The technology side is led by Marcin Sompoliński, PhD Eng., co-owner and specialist in designing HVAC installations for controlled environments. The team numbers about 20 people in the design office and on site; for calculations outside standard practice we cooperate with specialists from the academic staff of the Wrocław University of Science and Technology. We hold licences to design, build and operate installations, so we run the investment under a single contract.
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