Pharmaceutical Facility Construction ServicesCleanrooms, Labs & GMP Compliance
At Bohden Contracting Group, we specialize in delivering GMP / cGMP-compliant pharmaceutical facility construction—from sterile cleanrooms and analytical labs to end-to-end manufacturing suites. Backed by decades of expertise in construction for highly regulated industries, we bring precision, compliance, and construction excellence to every project.
Our Core Pharma Facility Construction Capabilities
Whether you are launching a new drug pipeline, scaling up production, or retrofitting existing facilities, our team ensures your facility meets the highest regulatory and operational demands.
- Cleanroom Construction & Renovation
- Preventative Maintenance
- Capital Projects & Lab Expansions
- Meeting FDA, USP, and ISO Standards
Why Choose Bohden Group for Pharma Facility Builds & Cleanrooms
- Deep Industry Expertise – We have extensive experience working in regulated sectors—pharma, biotech, medical manufacturing—and understand the nuance of FDA, EMA, and global GMP requirements.
- Construction-Driven Compliance – From day one, our construction methods embed compliance: material selection, sequencing, documentation, and modular prefabrication help reduce contamination risk, rework, and downstream validation burden.
- Turnkey Integration – We offer an integrated path: design coordination, construction management, systems integration, and qualification support. You gain a single point of accountability.
- Risk Mitigation & Schedule Discipline – We leverage robust planning, fencing of critical path items, and modular construction techniques to help contain change orders, stay on schedule, and manage costs.
- Quality Assurance & Documentation – Every phase is documented, traceable, and auditable—material submittals, weld logs, cleanroom verification, test protocols, and commissioning data archives.
Frequently Asked Questions
General
What is pharmaceutical construction?
Pharmaceutical construction involves designing and building facilities used for drug research, manufacturing, and packaging—such as cleanrooms, laboratories, and GMP production suites. These facilities must meet strict regulatory standards to ensure product safety and quality.
What makes pharmaceutical construction different from regular commercial construction?
Unlike traditional projects, pharmaceutical facilities require GMP/cGMP compliance, contamination control, pressure differentials, specialized HVAC, and validated materials and systems. Every component must be designed and documented to meet FDA, EMA, or ISO cleanroom standards.
Who regulates pharmaceutical facility construction?
In the U.S., the FDA (Food and Drug Administration) sets Good Manufacturing Practice (GMP) requirements under 21 CFR Parts 210–211. Internationally, facilities follow EMA (Europe), WHO, or PIC/S guidelines.
What types of pharmaceutical projects do you build?
Common projects include:
- GMP / cGMP cleanrooms
- Biopharmaceutical manufacturing plants
- Analytical and QC laboratories
- API production facilities
- Fill/finish suites
- R&D or scale-up labs
- Warehouse and material handling areas with environmental control
Cleanrooms & Labs
What cleanroom classifications can you build?
We design and construct cleanrooms from ISO Class 5 to Class 8 (or GMP Grades A–D), depending on process requirements.
What’s the difference between ISO cleanroom classifications and GMP Grades?
ISO standards define airborne particle limits, while GMP Grades focus on operational cleanliness for pharmaceutical production. Many facilities require both frameworks to overlap.
What materials are used in cleanroom construction?
Typical materials include seamless epoxy flooring, vinyl or FRP wall panels, stainless steel pass-throughs, flush windows, and aluminum ceiling grid systems. All materials are selected for cleanability, chemical resistance, and minimal particle shedding.
Can existing buildings be converted into cleanrooms or GMP spaces?
Yes. Retrofitting existing industrial or office space into GMP-compliant environments is common. We assess building envelope, utilities, and structural capacity before design.
GMP / cGMP Compliance
What does GMP or cGMP mean?
GMP (Good Manufacturing Practice) and cGMP (current GMP) are regulatory frameworks ensuring pharmaceutical products are consistently produced and controlled according to quality standards.
How do you ensure GMP compliance during construction?
We follow documented procedures for material selection, installation, air barrier testing, commissioning, and validation readiness. Our process includes traceable documentation for IQ/OQ/PQ phases.
What documentation is provided for regulatory compliance?
Clients receive full turnover packages, including as-built drawings, test reports, cleanroom validation data, material certifications, and maintenance manuals—all compliant with GMP requirements.
How do you design for cross-contamination control?
Layouts are planned with unidirectional flows for personnel and materials, pressure cascades, segregated zones, and controlled airlocks.
