Expertise

Engineered to the regulations that govern the industry.

Cleanroom and HVAC engineering, contamination control, and the international standards our designs are built to.

(01) Contamination Control

Cleanroom & HVAC Systems.

Classified cleanrooms and HVAC engineered for stability and control — designed to the classification requirements of ISO 14644.

  • Contamination control
  • Pressure cascade management
  • ISO-class stability
Systems We Engineer
Controlled environments and clean utilities, coordinated to one model.
Classified CleanroomsISO
HVAC & Pressure CascadeHVAC
Water for Injection & Purified WaterWFI/PW
Clean SteamCS
Process GasesGAS
(02) Standards & Compliance

Designed to the standards that govern the industry.

Our designs align with international pharmaceutical standards and quality frameworks — so facilities are inspection-ready and qualification follows the design, not the other way around.

EU GMP

EudraLex Vol. 4 · Annex 1

Good Manufacturing Practice, including sterile and contamination-control requirements.

cGMP · FDA

21 CFR Parts 210/211 · 11

Current GMP and electronic records & signatures for data integrity.

GAMP 5

Automation & CSV

Risk-based approach to computerized-system validation and automated processes.

ISO 14644

Cleanroom Classification

Air cleanliness by particle concentration — ISO 5 to ISO 8 environments.

ICH

Q7 · Q9 · Q10

Quality systems, quality risk management, and pharmaceutical quality frameworks.

ISPE

Baseline & C&Q Guides

Industry good-practice for facility design and commissioning & qualification.

Designing a facility to a specific standard?