Cleanroom Consultants for All Industries
COVID-19
Initiative
Cleanetics has created the CAiiRE Initiative™ to protect the critically-ill and their healthcare providers from the dangers of Novel Viruses—the future of Covid care.
503
A/B
Is your compounding facility a registered 503a or 503b environment? Our team consults, designs, builds, and certifies, making us a truly a turnkey provider.
USP
797/800
Consult with Cleanetics to design and build your USP 797 & 800 sterile compounding pharmacy. Whether a renovation or a new construction, Cleanetics will deliver a fully compliant cleanroom environment.
Medical
Device
For decades, Cleanetics has assisted high-profile Medical Device companies in the design-build construction of their clean production facilities, as well as implementing long-term Preventative Maintenance and Sustainability plans.
Pharmaceutical
& Biotech
Cleanetics has an impressive portfolio of success in the renovation of several Pharmaceutical Manufacturing and Biotechnology facilities, where our custom sterile surfaces transformed deteriorated production spaces into cGMP compliant environments.
Semi-Conductor
Due to the sensitive nature of microchip manufacturing, Semiconductor cleanrooms require strict control over all contaminants, including particulates, out-gassing, toxic gas, and static. Cleanetics has extensive experience in delivering these submicron facilities.
Cannabis
With the heightened demand of Medical Marijuana and CBD, cleanroom environments for Cannabis production are faced with stricter regulations as more agricultural licenses are being issued across the nation.
Aerospace
As clean production standards have increased in the Aeropace industry, Cleanetics has consulted and engineered several high-profile international projects, from satellites to space exploration.
Delivering Excellence Across All Cleanroom Sectors
Since 2003, Cleanetics has delivered consulting, design, construction, certification, and maintenance services for cleanrooms across every major scientific and industrial sector. From healthcare and pharma to aerospace, semiconductor, biotech, and research environments, we bring your cleanroom facility to full certification with precision and compliance.
USP<797> Hospital Pharmacies
Facilities requiring strict control over sterile compounding environments. Cleanetics supports compliant design, construction, and certification to meet USP<797> standards for patient safety and product integrity.
503A / 503B Compounding Cleanrooms
Compounding pharmacies with heightened regulatory oversight. Cleanetics delivers turnkey cleanrooms engineered for aseptic processing, hazardous and nonhazardous drug preparation, and FDA/State Board compliance.
Aerospace
Precisiondriven environments supporting component manufacturing, assembly, and testing. Cleanetics builds controlled environments that meet stringent particulate, airflow, and contaminationcontrol requirements for missioncritical aerospace applications.
Automotive
Advanced manufacturing spaces for EV components, battery systems, sensors, and highprecision assemblies. Cleanetics provides cleanrooms that support quality, repeatability, and contaminationsensitive production lines.
Semiconductor
Ultralow particulate environments essential for wafer fabrication, microelectronics, and advanced packaging. Cleanetics delivers ISOclassified cleanrooms with precise environmental control for highyield semiconductor manufacturing.
Biotechnology
Research, development, and production spaces requiring controlled environments for cell culture, gene therapy, biologics, and advanced therapeutics. Cleanetics supports scalable cleanroom solutions for emerging and established biotech operations.
Pharmaceutical
GMPcompliant cleanrooms for drug development, formulation, and manufacturing. Cleanetics ensures environmental control, documentation, and certification aligned with FDA, EMA, and global regulatory expectations.
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As a cGMP subject matter expert, Cleanetics executes renovation and newconstruction projects for controlled environments operating under FDA, EMA, ICH Q7/Q9/Q10, and ISO14644 frameworks. Our engineering and quality teams support facilities across Pharmaceutical Manufacturing (aseptic and terminal sterilization), Medical Device assembly and packaging, Aerospace and Semiconductor fabrication, Research and Development laboratories, USP<797>/<800> Hospital Pharmacies, and all aseptic processing environments requiring validated contaminationcontrol strategies. Each project is executed in alignment with defined URS, FRS, and DQ requirements to ensure the cleanroom is engineered to support process flows, environmental classifications, and qualitysystem expectations.
Cleanetics integrates a full lifecycle qualification approach consistent with ISO146441/2, EU Annex1, and cGMP guidance. Postconstruction services include:
- HEPA/ULPA filter integrity testing (PAO/DEHS)
- Airflow visualization (smoke studies) for unidirectional and nonunidirectional systems
- Air change rate verification and pressurization cascade mapping
- Particle count classification (asbuilt, atrest, and operational)
- Recovery time testing and containment verification
- Temperature, humidity, and differential pressure mapping
- Preventative maintenance programs aligned with the cleanroom's PQ and ongoing stateofcontrol requirements.
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These activities ensure the cleanroom maintains its validated environmental state of control throughout its operational lifecycle and remains compliant with regulatory expectations for aseptic processing and contamination control.
Because 21CFRPart11 governs the integrity, security, and auditability of electronic records used in environmental monitoring and process validation, Cleanetics provides a fully compliant monitoring platform designed for continuous, 24/7 acquisition of critical environmental parameters. The system supports:
Because 21CFRPart11 governs the integrity, security, and auditability of electronic records used in environmental monitoring and process validation, Cleanetics provides a fully compliant monitoring platform designed for continuous, 24/7 acquisition of critical environmental parameters. The system supports:
- Validated data handling and secure audit trails
- Rolebased access control and electronic signature compliance
- Redundant data storage and alarm management
- Realtime trending, deviation capture, and batchrecord integration
This infrastructure enables your facility to maintain documented, traceable control over environmental conditions that directly impact product quality, sterility assurance, and regulatory compliance.