The free guide aims to demystify the cleanroom design process, particularly for organisations undertaking their first cleanroom project or facility redesign. It provides structured guidance across eight key decision areas, from regulatory requirements and classification standards to architectural specifications and environmental controls.
"Cleanroom design involves numerous technical and practical considerations that can be overwhelming, especially for teams new to the process," said Royce Tourtillott, President of Life Science Solutions. "We created this guide to serve as a collaborative planning tool that helps our clients think through critical decisions before they sit down with our design experts, ultimately resulting in more efficient projects and better outcomes."
Comprehensive Coverage for Modern Cleanroom Applications
The guide walks users through essential planning considerations including:
- Product and process requirements for aseptic processing and ATMP manufacturing
- Regulatory compliance across FDA, EMA, MHRA, and Health Canada standards
- Classification strategies and contamination control approaches
- Personnel flow, segregation, and pressure cascade design
- Temperature and humidity specifications
- Architectural options including wall systems, flooring, and lighting
- Application-specific requirements for specialised manufacturing environments
The resource is particularly valuable for organisations working with advanced therapies, including live cell cultures, viral vectors, and other cell and gene therapy products, which require careful consideration of open versus closed processing systems.
Supporting the Industry's Evolution
As the life sciences sector continues to expand, particularly in Advanced Therapy Medicinal Products and Biologics, demand for properly designed cleanroom facilities has intensified. Life Science Solutions developed the guide based on decades of experience supporting pharmaceutical and biotechnology clients through R&D laboratory setups, clinical production facilities, and full-scale GMP manufacturing installations.
The guide is both a planning worksheet and consultation framework, allowing project teams to document their requirements, identify knowledge gaps, and prepare for productive conversations with cleanroom design specialists.
CLICK HERE to download the Cleanroom Project Design Guide.
