Pharmaceutical cleanrooms — GMP compliant

Pharmaceutical cleanrooms — GMP-compliant construction

A pharmaceutical cleanroom is a controlled environment designed to EU GMP Annex 1, where beyond particle concentration you also control microbiological cleanliness, the pressure cascade and air recovery time. GMP classification divides zones into grades A, B, C and D, mapped onto ISO 14644-1 classes in the at-rest and in-operation states. Clima Line designs and builds such environments turnkey — from URS, through HVAC with HEPA H14 filtration, to IQ/OQ/PQ validation and the qualification documentation package.

GMP grades A–D versus ISO classes

The pharmaceutical industry runs two classification systems in parallel. ISO 14644-1 describes particle concentration only. GMP adds microbiological limits and — critically for HVAC design — the distinction between at rest (installation complete, equipment running, no personnel) and in operation (full production with staff present).

The practical consequence is that a room designed tightly for the at-rest state falls out of class the moment operators enter. Design must target the in-operation state.

What EU GMP Annex 1 (2022 revision) changed

Contamination Control Strategy (CCS) — a formalised, holistic contamination control strategy covering room design, personnel and material flows, utilities and monitoring. The CCS is not an appendix to the design; it is the superior document the design should follow from.
Emphasis on airflow visualisation — smoke studies in grade A have become a standard element of qualification rather than an option. Plan and budget for them at design stage.
Periodic requalification — grades A and B every 6 months, grades C and D every 12 months. This is a real, recurring operating cost that belongs in the investment TCO.
Barriers and isolators — Annex 1 clearly favours RABS and isolator technology where feasible, which changes the demands on the supporting HVAC.

HVAC requirements for pharmaceutical cleanrooms

In a pharmaceutical investment, HVAC accounts for 50–60% of the budget and effectively determines the qualification outcome. Key design parameters: a pressure cascade of typically 10–15 Pa between adjacent grades, terminal HEPA H14 filters installed at the supply point so that in-situ integrity testing is possible, air change rates matched to the in-operation state, humidity and temperature control with reserve capacity, and continuous parameter recording with an audit trail.

The most common causes of failed qualification

pressure cascade collapsing when airlocks open during material transfer,
HEPA filters located in the air handling unit instead of terminally — no possibility of integrity testing at the supply point,
no cooling capacity reserve, so temperature tolerance is lost in summer,
monitoring without continuous recording — no evidence of class compliance between periodic qualifications.

Clima Line experience in controlled environments

We have been delivering cleanrooms since 2013, with an engineering team of over 15 years’ experience: five cleanrooms above 1,000 m² and around ten retrofits of operating facilities. In the medical sector we delivered the HVAC system for a Regional Blood Donation and Haemotherapy Centre.

The technology side is led by Marcin Sompoliński, PhD Eng., co-owner of Clima Line. We cooperate with academic staff of the Wrocław University of Science and Technology and hold full licences to design, build and operate the installations. Documentation can be prepared in English for international audits.

Planning a GMP cleanroom?

Send us your process description and required grades — we will prepare a concept with an air balance and a quotation. Call +48 32 450 56 66 or write to biuro@clima-line.pl.