EPC and Turnkey Industrial Contracts
We take on the complete project under a single contract and a single point of responsibility. Fewer interfaces, more control of cost, schedule and performance through to operation.
Multidisciplinary Design in BIM (FEL 2/3)
We develop projects from FEL 1 to detailed design, integrating every discipline in BIM. More precision, less rework and data-driven decisions.
Civil Construction and Industrial Works
We execute complete industrial works, from the foundations to the qualified critical areas. Robust structures, controlled environments and a high construction standard end to end.
Electromechanical Assembly and Prefabrication
We install equipment and systems with technical rigor and full traceability. Quality assured from assembly through to the project's final qualification.
Cleanrooms and Classified Environments
We design and build cleanrooms in accordance with ISO 14644 and GMP standards. Strict control of particles, pressure, temperature and humidity in every room.
Pharmaceutical HVAC and Classified Air Conditioning
We implement HVAC systems with precise control of pressure and particles. Stable, monitored environments in full compliance with GMP grades.
E-Houses and Electrical Switchboards
We design and manufacture e-houses and switchboards with state-of-the-art technology. Prefabricated, tested solutions ready to operate in complete safety.
CAPEX Management and Construction Control
Execution of works in operating plants without interrupting production.
Precise planning, risk control and guaranteed operational continuity.
ANVISA, FDA and EMA Compliance
We deliver projects aligned with GMP and the main global regulatory agencies. Proven track record of plants approved with no shutdowns in inspections.
Electromechanical Assembly in Critical Areas
We install process equipment and skids with technical rigor and traceability. Quality assured from assembly through to the system's final qualification.
Commissioning, Startup and Assisted Handover
We validate every system through to the safe start of production. Assurance that everything works as designed and within the standards.
All the engineering in one place
MSE brings design, construction, assembly and qualification together under a single point of responsibility. An in-house, multidisciplinary team, with no dependence on critical subcontractors.
A pharmaceutical plant is not an industrial shed with equipment inside. It is a project in which air, pressure, temperature and the flow of people and materials are part of the production process and must be demonstrated to ANVISA. Every cleanroom, every HVAC duct and every utility point is born in the design with a regulatory function. That is why hiring an engineering company that masters regulated environments changes the outcome: fewer deviations in qualification and an operation that passes inspection.
A cleanroom is an environment with control of particles, differential pressure, temperature, humidity and air changes. The technical reference is the ISO 14644 standard, which classifies the environment from ISO 1 to ISO 9 according to the number of particles per cubic meter. The old class 100 cleanroom corresponds today to ISO 5; class 10,000 to ISO 7; class 100,000 to ISO 8. In Brazil, ANVISA's RDC 658/2022 translates this into grades A, B, C and D of Good Manufacturing Practices. Grade A is the critical point of sterile filling; grade D covers areas for solids preparation and primary packaging. Defining the grade of each room is the first design decision, because it is what sizes the HVAC, the HEPA filtration, the finishes and the cost per square meter.
The work begins with the conceptual study (FEL 1 and FEL 2), which defines the process flow, area segregation, classification zoning and the utilities strategy. This phase produces the URS, the user requirements specification, which will be the basis for all qualification. Then come basic design (FEL 3), detailed design in BIM, with all disciplines coordinated, and the issue of construction documents. Only then do earthworks, foundations, structure, envelope, cleanroom panels, HVAC, clean utilities, electrical and automation come in. The project ends with commissioning and installation, operational and performance qualification (IQ, OQ and PQ), which generate the documented evidence required in the health inspection.
The HVAC system of a pharmaceutical plant does much more than air conditioning. It maintains the pressure cascade between rooms, ensures the air changes per hour required for each grade, filters the air in stages down to the terminal HEPA filters and controls temperature and humidity within validated ranges. Each zone needs dedicated or segregated air handling units to avoid cross-contamination, and the entire system is monitored by a BMS with continuous recording. An undersized HVAC is the most common cause of failure in qualification, because differential pressure and recovery time are tested and documented room by room.
Beyond HVAC, the plant depends on utilities that are also qualified: purified water and water for injection, clean steam, oil-free compressed air, nitrogen and CIP and SIP cleaning systems. On the electrical side, a pharmaceutical plant requires redundancy and continuity: substation, generator sets, UPS for critical areas and switchboards with traceability. MSE designs and manufactures its own e-houses and electrical switchboards, which reduces interfaces and energization lead times.
A new mid-sized facility usually takes 18 to 30 months between concept definition and validated startup. An expansion or renovation of a classified area in an existing plant takes 8 to 14 months. What weighs most on the schedule is not the civil works, but qualification and long-lead equipment: air handling units, purified water generators, autoclaves and process skids. Specifying these items during the design phase and integrating the validation plan into the construction schedule is what protects the deadline.
Cost is driven by the classification grade and by the complexity of the utilities, not by built area. A square meter of grade D area costs a fraction of a square meter of grade A area with isolators and aseptic filling. The type of product (solids, liquids, steriles, biologics), the need for containment for highly potent products and the power infrastructure available at the site also weigh heavily. A well-executed conceptual design reduces this cost by avoiding over-classifying rooms that do not need it.
A large share of pharmaceutical projects takes place inside plants that cannot stop. This requires planning of work fronts, dust containment barriers, access control, change management and coordination with the client's quality assurance. MSE carries out expansions, renovations of classified areas and new lines in operating plants, keeping production and the regulatory status of neighboring areas intact.
Hiring the designer, the builder, the installer and the qualification company separately looks cheaper on paper. In practice, it creates gray areas between contracts, and that is where rework, delays and inspection deviations appear. In the EPC turnkey model, design, construction, assembly, commissioning and qualification support stay under a single technical point of responsibility, with an in-house, multidisciplinary team. For 47 years MSE has delivered pharmaceutical plants in this model, with operations approved in ANVISA, FDA and EMA inspections.
The ISO 14644 classification indicates the particle limit per cubic meter of air. ISO 5 (formerly class 100) allows up to 3,520 particles of 0.5 µm and is used for sterile filling, grade A. ISO 7 (class 10,000) corresponds to grade B at rest and grade C in operation. ISO 8 (class 100,000) is equivalent to grade D, typical of solids and primary packaging areas. The lower the number, the greater the filtration, the air changes and the cost.
RDC 658/2022 establishes the Good Manufacturing Practices for medicines and covers facilities, flows, area classification, HVAC, utilities and qualification. In practice, the inspection verifies whether the design prevents cross-contamination, whether the classified areas are qualified with documented evidence and whether the critical systems have monitoring and traceability.
A classified area inside an existing plant takes 8 to 14 months between design and qualification. A new mid-sized pharmaceutical plant takes between 18 and 30 months. The schedule depends on the classification grade, the complexity of the utilities and the lead time of HVAC and process equipment.
Yes. We work in an EPC turnkey model: multidisciplinary design in BIM, civil construction, cleanrooms, pharmaceutical HVAC, utilities, electromechanical assembly, our own e-houses and switchboards, commissioning and IQ, OQ and PQ qualification support, all under a single technical point of responsibility.
Yes, and it is the most common scenario in expansions and modifications. It requires planning of work fronts, containment barriers, access control, change management and alignment with the client's quality assurance to preserve the regulatory status of the areas in operation.
We develop solutions for the pharmaceutical industry,
creating safe, efficient production environments aligned
with the highest quality standards.
