Cleanrooms & Controlled Environments

From project definition to certification: Ekium designs and validates your cleanrooms to ensure complete control over your controlled environments.

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We possess the full range of expertise required to design all types of Controlled Atmosphere Areas (CAAs), each of which meets very specific criteria, such as dust levels, bacterial levels, temperature, and humidity levels…

We provide turnkey solutions across various industrial sectors, including pharmaceuticals, biotechnology, laboratories, cosmetics, food processing, batteries, microelectronics, and nuclear energy.

Our Applications

  • Aseptic and/or contained areas in (radio)pharmaceutical production in accordance with GMP

  • R&D laboratories and production areas involving biological risks, radioisotopes, and fine chemicals

  • Cell therapy, immunotherapy, medical diagnostics, animal facilities

  • Food processing, flavors and fragrances, aerospace

  • Critical hospital areas: production of cytotoxic drugs and sterile products

  • Climate chambers (ecotrons, etc.) and incubation chambers in biotechnology

  • Decontamination/disinfection processes

  • Environmental monitoring

  • Production equipment (isolators, weighing, washing, sterilization, freeze-drying)

Our deliverables

  • Project definition, programming, block diagrams, PFDs, PIDs

  • Regulatory gap analysis

  • Flow diagrams, layouts

  • Production & logistics capacity simulation, utility balance sheets

  • Master plans, feasibility studies

  • Preliminary design (APD), basic design (APS), detailed studies for all technical systems and equipment

  • Sizing, definition, and technical and functional specifications; bid documents

  • Project management and EPCMV (Engineering, Procurement, Construction Management, and Validation)

  • Design/Implementation

  • Risk analyses (GMP Impact Assessment, HAZOP, etc.), ATEX zoning, radiation, nuclear contamination

  • Budget estimates and scheduling

  • Validation and verification plans (ASTM E2500)

  • Assistance with specifications and management of interfaces with production equipment

  • Construction and EHS Management (Environment, Health, and Safety)

Regulations

  • GMP

  • FDA

  • ICH

  • ISO 14 644

  • NF EN ISO 13485

  • NFS 90 351

Utilities

  • HVAC for cleanrooms (aseptic and containment)

  • Pharmaceutical utilities: purified water, water for injection, pure steam, gases, liquid nitrogen

  • Partitions and finishes

Group presence

The Snef Group operates across four continents—the Americas, Europe, Africa, and Oceania—in 30 countries and 80 cities, with a network spanning more than 100 international locations.