ISO 7 and 8 Clean Room Design

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Confidential Medical Device Company

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South Central United States

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3,700 SF

A technician wearing clean room attire including a hairnet, face mask, blue shirt, and purple gloves operates sophisticated medical device manufacturing equipment in a BSA-designed facility. The worker is operating a stainless steel processing machine with a digital control panel displaying operational parameters, while seated at a black ergonomic chair. The clean room features bright white walls, recessed lighting, blue flooring, and visible hallway access points with strategic lighting. The specialized equipment includes transparent guard panels, overhead mechanical components with illumination, and precise manufacturing controls for maintaining the sterile production environment required for medical device fabrication.

Industrial HVAC equipment room with a large silver air handling unit by Airedale Engineers featuring multiple access panels and monitoring displays, connected to extensive insulated ductwork marked with 'RETURN' and 'SUPPLY' directional indicators. The mechanical system includes bright blue pipes mounted to the ceiling with pressure gauges, yellow safety railings along a platform, and exposed building infrastructure with metal framework overhead. The temperature control system is housed in a concrete-floored mechanical space designed by BSA, with various control panels and electrical components mounted to the unit.

A state-of-the-art clean room laboratory for medical device manufacturing, featuring technicians in blue protective coveralls and hairnets working within a controlled environment. The space includes transparent plastic strip curtains separating processing areas, stainless steel equipment including pressure vessels and control panels with digital displays, and polished metal cabinetry along the walls. The facility has bright overhead lighting, a seamless blue floor, and maintains strict sterility protocols with specialized manufacturing equipment visible throughout the production line, all designed by BSA for precision medical device production.

Modern medical device manufacturing clean room featuring a sophisticated material processing line with large rolls of white material mounted on stainless steel stands feeding into a central processing machine. The pristine space has bright white walls, blue speckled flooring, recessed ceiling lights, and overhead utility connections. Equipment includes status indicator lights, control panels with emergency buttons, a metal access stairway on the left, and ceiling-mounted service connections. The BSA-designed facility maintains controlled environmental conditions necessary for medical-grade production, with additional storage visible in the hallway beyond featuring red containers.

This confidential project involved designing and implementing a new ISO 7 and 8 clean room and associated support areas within an existing bio-pharma complex in Austin, Texas. The clean room was designed to meet strict classification requirements while supporting operational flow and production efficiency.

BSA employed a lifecycle-driven design process to ensure long-term operational performance, maintainability, and alignment with facility standards. The team introduced a modernized MEP infrastructure and incorporated innovative clean room design strategies tailored to the client’s needs.

The team strategically configured the layout so production activities follow the logical sequence of operations and meet the cleanliness requirements of each zone—maximizing both compliance and efficiency.

Key features of the ISO 7 and 8 clean room design in this Austin bio-pharma facility include:

Lifecycle analysis for long-term efficiency and maintainability
MEP due diligence to identify and implement essential system upgrades
Coordination of process equipment and integration with proprietary systems (e.g., Plascore)
Weekly cross-disciplinary coordination with in-house MEP trades and the client’s validation team
Early release packages enabling utility upgrades during a scheduled facility shutdown

Through precise planning, technical coordination, and an innovative approach to clean room standards, BSA successfully delivered a high-performance facility upgrade within a live production environment.

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Disciplines

Architecture, Engineering

Project Contact

Craig Puccetti

ISO 7 and 8 Clean Room Design

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