Advanced Modular Cleanrooms for Healthcare and Medical Devices
Healthcare today demands a seamless connection between the clinical environments where patients receive care and the high-tech devices and compounds used within them. CleanSpace design builds controlled environments across both sides of that equation, from hospital surgical suites and sterile compounding pharmacies tomedical device manufacturing lines and diagnostics labs. Where patient safety and product integrity are non-negotiable, your facility has to perform without exception.
At CleanSpace, we specialize in medical device cleanroom manufacturing designed to meet the highest standards of safety, quality, and regulatory compliance. Our controlled environments minimize particulate contamination, microbial presence, and environmental variability, ensuring consistent product integrity for even the most sensitive devices. From ISO-classified cleanrooms to validated processes and rigorous monitoring, we support the full production lifecycle with precision and reliability. By integrating advanced engineering with disciplined operating procedures, CleanSpace helps manufacturers bring compliant, high-performance products to market with confidence.
Our turnkey approach combines design, engineering, manufacturing, and validation under one roof, streamlining timelines while maintaining strict adherence to FDA, ISO 13485, and GMP requirements. We tailor each cleanroom solution to the specific needs of medical device production, whether assembly, packaging, or specialized processes while delivering scalable systems that evolve with your business. With CleanSpace, clients gain a trusted partner focused on operational efficiency, risk reduction, and long-term performance in critical manufacturing environments.
Our certifications
Precision Manufacturing Suites for Medical Devices
Medical device and diagnostics manufacturing requires the same level of environmental discipline as clinical care, applied to production scale. Temperature and humidity fluctuations compromise reagent kits. Particles contaminate diagnostic sensors. Static discharge damages sensitive assemblies. CleanSpace builds manufacturing environments where those variables are removed from the equation so your production line delivers consistent, certifiable output.
Sterile Processing Facilities
Engineers ISO-classified cleanrooms to ensure compliant, contamination-free sterilization of medical devices that meets strict regulatory and patient safety standards.
Compouding Pharmacies
503A, 503B, USP 797 and USP 800 compliant clean spaces forsterile and hazardous drug preparation
Patient Isolation Rooms
Negativeor positive pressure configurations for immunocompromised patients andinfectious disease containment
Procedure Suites
Purpose-designedspaces where contamination control and equipment performance intersect
Imaging and Procedure Suites
Purpose-designed spaces where contamination control and equipment performance intersect
Hospital Expansion and Renovation
Modular construction that minimizes disruption to active patient care areas during build-out
503A, 503B, USP 797 and UPS Compounding Pharmacies
Sterile compounding pharmacies, including 503A and 503B facilities, operate under the most stringent regulatory requirements in healthcare. USP <797> governs sterile compounding environments, while USP <800> establishes requirements for handling hazardous drugs, where precision and contamination control are critical to patient safety.
CleanSpace delivers purpose-built cleanrooms with validated airflow, robust contamination control, and complete documentation ensuring inspection readiness from day one. Our design-build solutions are tailored to both 503A and 503B facilities covering hazardous drug containment, peptides, hormones, and GLP-1 to aseptic processing, providing scalable, compliant systems for safe, efficient, and audit-ready sterile compounding operations.
- USP 797 | Sterile Compounding Environments
- USP 800 | Hazardous Drug Handling Facilities
- FDA 21 CFR | Manufacturing and Diagnostics Compliance
- HEPA and ULPA Filtration Standards
- Modular Cleanroom Systems
- Full Documentation for Facility Validation and Audit
Precision Manufacturing Suites for Healthcare Systems
CleanSpace specializes in delivering cleanroom and critical environment solutions within active, occupied hospitals, where ICRA protocols, infection prevention, and patient safety are non-negotiable. Our teams execute every phase with strict containment measures, clean build practices, and disciplined site controls including barrier management, dust containment, negative air, and safe material movement, minimizing disruption across sensitive care environments. From renovations in adjacent patient areas to upgrades within critical hospital spaces, CleanSpace helps clients maintain compliance, protect occupants, and keep projects moving safely and efficiently in complex operational settings.
ICRA
Infection Control Risk Assessment for Healthcare Construction
Clean Build
ControlledConstruction Practices in Sensitive Environments
Patient Safety
Protectionof Patients, Staff, and Clinical Operations
Tag In and Tag Out
Controlled environments for product shelf-life studies, environmental stress testing, and QC validation
Dust and Debris Containment
Reduced Risk During Active Contaminant Migration
Negative Air and Pressure Control
Prevention of Airborne Contaminant Migration
Why CleanSpace?
We have a very demanding project in support of the Project Warp Speed program. We selected CleanSpace because we know they will develop a program to get our project done very rapidly.
Projects We've Delivered
PCT Filling Operation
Process Systems
Gene Therapy Pilot Plant
cGMP Manufacturing Facility
