In the pharmaceutical industry, engineering is an integral part of quality and compliance. There is no margin for error. We provide specialized Mechanical, Electrical, and Plumbing (MEP) solutions that form the compliant heart of your manufacturing and research facility.
Addressing the core challenges you face every day.
Every single component, weld, and airflow calculation must be designed, installed, and meticulously documented to meet stringent cGMP, DRAP, and FDA regulations. Non-compliance is not an option.
Maintaining sterility and preventing cross-contamination is paramount. This requires precisely controlled HVAC pressure cascades, HEPA/ULPA filtration, and sanitary, crevice-free surfaces.
Critical utilities like WFI, clean steam, and compressed air must be delivered with flawless purity and repeatability. All monitoring systems must be secure and compliant with 21 CFR Part 11 for data integrity.
Moving from installation to a fully operational, approved facility requires a complex, document-heavy validation process (IQ, OQ, PQ). This can be a major project bottleneck without expert support.
Solutions Tailored for MEP Engineering for Pharmaceutical & Life Sciences
Validated design and installation of HVAC systems for Grade A, B, C, and D classified manufacturing areas, ensuring precise control of temperature, humidity, pressure differentials, and particle counts.
Turnkey engineering of Purified Water (PW) and Water for Injection (WFI) generation, storage, and distribution loops using orbital-welded SS316L piping and sanitary components.
Installation of high-purity piping systems for clean steam, validated compressed air, nitrogen, and other process gases, complete with full traceability and documentation.
Installation and qualification of Building Management and Environmental Monitoring Systems for centralized, compliant control and monitoring of all critical parameters.
Installation of GMP-compliant cleanroom panels, doors, flooring, and integrated components to create a complete, sealed, and functional controlled environment.
Design and installation of fire detection and suppression systems (including clean agent systems for sensitive areas) that are compliant with both life safety codes and cleanroom standards.
Providing and executing comprehensive, GMP-compliant Installation Qualification (IQ) and Operational Qualification (OQ) protocols for all MEP systems we install.
Installation and commissioning of central utility plants, including chillers, cooling towers, boilers, and pumps that serve as the backbone for your entire facility.
A leading pharma client needed to construct a new DRAP and EU GMP-compliant facility for sterile injectables. This required an ISO 5 (Grade A) filling zone within an ISO 6 (Grade B) background, a fully validated WFI loop, and a 21 CFR Part 11 compliant Environmental Monitoring System (EMS).
An existing OSD plant was facing cross-contamination risks and high energy costs due to an outdated HVAC system with poor dust control. They needed to upgrade to a compliant system for products with different OEL (Occupational Exposure Limit) levels.
We don't just build, we qualify. We provide a comprehensive validation documentation package (IQ, OQ) that is organized, traceable, and ready for your PQ and regulatory audits, ensuring a faster path to approval.
Our teams have proven, hands-on experience designing and constructing ISO 14644 compliant cleanrooms (Grade A, B, C, D) for sterile injectables, oral solid dosage (OSD), and API manufacturing.
We are experts in the orbital welding of SS316L piping for high-purity systems. Our certified welders and documented procedures (weld logs, boroscopy) guarantee sanitary, contamination-free product contact surfaces.
We manage the entire MEP lifecycle, from User Requirement Specification (URS) to final handover. This single point of accountability minimizes risk and ensures seamless coordination between all disciplines.
"Their deep understanding of pharmaceutical validation and DRAP requirements was the key to our project's success. The quality of their orbital welding and the comprehensive documentation package was exceptional. They are true partners in compliance."
Dr. Fatima Ahmed
Head of Quality & Compliance, Innova Life Sciences
We provide a comprehensive, audit-ready turnover package (TOP) that includes: as-built drawings, material traceability certificates (MTRs), weld logs, boroscopy reports, instrument calibration certificates, and fully executed IQ/OQ protocols.
We specialize in retrofitting. We use strict containment protocols, such as temporary clean partitions and HEPA-filtered air scrubbers, and plan work during scheduled shutdowns to prevent any contamination and minimize disruption to your validated operations.
For pharmaceutical cleanrooms, the standard is typically SS304 or SS316L stainless steel for supply and return air ducting within the classified areas to ensure a non-porous, cleanable, and non-particle-shedding surface.