Recently expanded guidelines, ISO 13485 (medical devices) and USP 800 (pharmaceutical compounding), emphasize an evolving landscape of risk management solutions for medical sciences. Harmonizing medical device cleanroom standards requires evaluation of not only cleanroom design, but also processes equipment, materials, consumables, and assemblies.

Prefab medical device cleanrooms ease adoption of new regulatory updates and reduce the speed-to-obsolete. Modular components reduce tooling, labor, material costs, and lead times because on-site installation requires no sawing or framing. Much like driving a new car off the lot, CleanPro® turnkey systems are installed and customized for immediate implementation. Pre-engineered modules expand flexibility for future retrofits, relocation, expansion, or evolving device requirements.

Guaranteed completion and final compliance testing are among the reasons CleanPro® is a trusted ally of enterprise device manufacturers. We leverage cleanroom design experience to draft, design, schedule, and coordinate installation. Strategic sourcing, logistics, and spend management allow on-time completion within a pre-approved budget. CleanPro® engineers specialize in building codes, adapting existing structures, and adhering to state, federal, and organizational mandates.

Cleanroom Classifications for Common Medical Device Applications

Authoritative documents such as ISO 14644 and FS-209E provide no specific instructions regarding activities carried out in medical device environments. Broadly, medical device manufacturing is conducted in an ISO Class 5 cleanroom (Fed. Class 3), while medical device packaging is conducted in an ISO Class 7-8 cleanroom. Classification of surrounding environments, isolators, and sterilization processes all require very specific performance criteria. These standards do not apply state board or FDA mandates.

Application	Classification
Device Reprocessing	ISO Class 7
Inplantable Devices	ISO Class 5
Medical Device Packaging	ISO Class 7-8

The CleanPro® Advantage

Cleanroom construction, much like building a new facility, requires a myriad of workers, parts, materials, and design considerations. Sourcing components and supervising construction for a new facility is not something you'd ever take on by yourself. Why would building a cleanroom be any different?

Cleanroom control systems and electrical designs are critical, but so are considerations for structural, architectural, and application compliance. Turnkey cleanroom solutions with modular components empower easy adaptation of adjacent structures, cascaded classification of interior rooms, expandable compliance, and relocation. By coordinating an expansive network of contractors, vendors, and compliance experts, CleanPro® turnkey cleanroom service consolidates cleanroom planning, design, engineering, construction, assembly, and certification into a single point of contact.

ISO 9001:2015 Certified

ISO 9001:2015 is an internationally recognized standard for Quality Management Systems (QMS). It is designed to provide companies with a set of principles that ensure a systematic approach to achieving customer satisfaction.

CleanPro® a division of Production Automation corporation, has implemented procedures to ensure a consistent standard of service for our customers, and customer feedback monitoring to uphold expectations between our vendors, warehouses, and the end-user. We continually conduct internal reviews to ensure that we are always improving.

Get Cleanroom Design Help at No Cost

Most lean medical device facilities seek "turnkey" cleanroom solutions when identifying a project lead is difficult or internal expertise is limited. CleanPro® expertise is always free. We offer tested and verified cleanroom installations from a single point of contact.

Different medical devices, regulatory bodies, and component sensitivity present unique challenges and consequences. Solving the right problem requires asking the right questions.

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