Designing a Custom Cleanroom: Key Factors to Consider
For industries like biotechnology, pharmaceuticals, and medical devices, cleanrooms are essential for product quality and regulatory compliance. When designing a custom cleanroom, several key factors must be considered to ensure it meets operational needs, industry standards, and future growth.
Cleanroom Classifications Determine the cleanliness level needed based on your operations. Cleanrooms are classified from ISO Class 1 (the cleanest) to ISO Class 9, with more sensitive processes, like medical device manufacturing, typically requiring ISO Class 5 or 7.
Airflow Design Airflow control is crucial. Higher-class cleanrooms use laminar airflow (unidirectional) to minimize turbulence, while lower classes may use turbulent airflow. High-Efficiency Particulate Air (HEPA) or Ultra-Low Particulate Air (ULPA) filters are essential for removing airborne particles.
Environmental Controls Key environmental factors like temperature, humidity, and pressure must be controlled. For instance, positive pressure is used to keep contaminants out, while negative pressure is used for hazardous materials.
Material Selection Choose non-shedding, easy-to-clean materials like vinyl flooring and stainless steel walls to maintain cleanliness and prevent microbial growth.
Modular vs. Permanent Design Modular cleanrooms offer flexibility and scalability, ideal for growing businesses, while permanent designs provide long-term durability.
Compliance Ensure your cleanroom design meets industry regulations, such as FDA or ISO standards, to avoid compliance issues. Working with experienced designers is essential.
Workflow Efficiency Design the layout for efficient workflows, including zoning for gowning and material transfer, and control access to critical areas to reduce contamination risks.
Scalability Plan for future growth by designing a cleanroom that can expand or upgrade easily as your business scales.
By considering cleanroom classification, airflow, materials, and workflow, you can design a custom cleanroom that supports both current needs and future growth. Contact ReadyStart CleanRooms for tailored cleanroom solutions that ensure your business's success in regulated industries.
