GMP-compliant cleanroom design and build consultancy for Life Science and pharmaceutical facilities. From URS through IQ/OQ/PQ validation — built within the quality systems of the world's leading pharma companies.
We support Life Science teams from initial concept and User Requirement Specification (URS) through detailed design coordination, contractor oversight and final qualification. Our work aligns with ISO 14644-1/2 classification, EU GMP Annex 1 (2022 revision) and 21 CFR Part 11 documentation expectations.
Founded in 2010, EKO HVOK has delivered cleanroom and HVAC consultancy across the quality systems of Pfizer, Johnson & Johnson, AstraZeneca, Lonza, TEVA and Astellas — across Ireland, Switzerland, Italy and Croatia.
Our boutique structure gives you direct access to senior project leadership without the overhead of an enterprise consultancy. Every engagement is led by Dejan Kanazir, with 20+ years of pharmaceutical project management experience.
| Classification | ISO Class 5 — 8 |
| Compliance | EU GMP Annex 1, 21 CFR Part 11 |
| Validation | DQ · IQ · OQ · PQ |
| HVAC Standard | HEPA H13/H14, ULPA U15 |
| Pressure Cascade | +15 Pa minimum between grades |
| Geographic Coverage | Ireland · Switzerland · Italy · Croatia |
A structured engagement model that aligns with regulatory expectations and reduces validation risk.
Drafting the User Requirement Specification, conceptual layout, classification map, airflow regime selection (unidirectional vs turbulent), and process-flow alignment with HVAC zoning.
Coordination between process, HVAC, architecture and facility teams. HEPA/ULPA terminal placement, differential pressure cascade, return air strategy, material/personnel flow.
On-site quality oversight during build, coordination with installation contractors, tracking against Design Qualification, change control management, and documentation hand-off.
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocol guidance. Particle count certification, recovery testing, environmental monitoring strategy.
Airborne particulate cleanliness classification (ISO Class 5 through 9), continuous monitoring strategy, and recovery testing protocols.
Sterile manufacturing requirements, contamination control strategy (CCS), grade A/B/C/D zoning, and Annex 1 compliant facility design decisions.
FDA electronic records and signatures compliance, audit trail design, and documentation aligned with US pharmaceutical regulatory expectations.
Facility classification, qualification protocol structure, and ongoing operational compliance for pharmaceutical manufacturing environments.
Drafting and review of the Validation Master Plan, qualification matrix definition, and risk-based qualification approach (ICH Q9).
Lean construction methodology applied to pharmaceutical projects — on-time, on-scope delivery from Design Qualification through PQ release.
Worked within the quality systems of leading pharmaceutical, biotechnology and Life Science organisations across Europe.
Whether you are scoping a new facility, retrofitting an existing one, or preparing for an Annex 1 readiness review — share your scope and we will respond with a clear technical and commercial path forward.
