When a clean room does not function as designed, the costs to the owner can be substantial. At Signer Harris Architects we have successfully limited risk for our clients through our ability to design to both the general GMP guidelines and the precise needs of their specific process. We have delivered clean room environments for Pharmaceutical, Biotechnology, Medical Device, Electronics, and Research and Development applications.
From stick-built custom designs to modular, pre-fabricated systems, to a hybrid design of the two approaches, we work with clean room manufacturers to coordinate and customize modular units, allowing us to create a built environment that integrates seamlessly with process protocols within larger environments. Our designs account for the appropriate auxiliary spaces such as airlocks and support the required people and material flow through a facility. Furthermore, we effectively plan, detail, and implement clean air delivery systems, pressurization, and airflow, successfully coordinating with our engineers to accommodate the mechanical requirements of the clean environment.
Selected Project Experience
- Raw Materials Sampling 700 square foot ISO-7 and ISO-8 Gowning Suite.
- Clinical Packaging 2,700 square foot packaging suite design to ISO-8 standards.
- Purification Suite 5,000 square foot process manufacturing suite (ISO-8) for drug production with ISO-7 Cold Room.
- Purification Suite 7,000 square foot process manufacturing suite (ISO-8) for drug production.
- Private Client 17,500 square feet clean room suite with spaces ranging from ISO-4 to ISO-8.
- Scale-up Lab Renovation of existing offices into new 6,000 square foot process manufacturing scale up lab (ISO-8).
- 2/3 Purification Suite Renovation of existing manufacturing suite for two specialized research spaces (ISO-7) with ISO-5 curtained area.
- Process Suite 2,500 square foot renovations for ISO-8 process manufacturing suite renovations.
- Column Project 5,000 square foot process manufacturing Column Packing Room/Purification suite (ISO-7).
- Broad Institute Clean Rooms Project Phase 1 5,000 square foot renovation of existing lab and office into ISO-6 clean rooms for sequencing platform research laboratories.
- Broad Institute Clean Rooms Project Phase 2 10,000 square foot renovation of existing lab and office into ISO-6 clean rooms for sequencing platform research laboratories.