A cleanroom design is a detailed process that requires balancing rigorous cleanliness standards with functional and practical considerations. Cleanrooms are essential across various industries, including biotechnology, electronics, and aerospace, where controlled environments are necessary to ensure product quality and compliance with industry standards.
Here’s a comprehensive checklist to guide you through designing a clean room that meets the required cleanliness levels, functionality, and safety measures.
The clean room classification is fundamental to any design process, as it sets the allowable number of particles per cubic meter at specified particle sizes, impacting the environment’s cleanliness. Cleanroom classes range from ISO Class 1, the strictest level of control, to ISO Class 9, the least stringent.
Selecting the appropriate class is essential, as it determines the required filtration levels and environmental controls. Industry-specific requirements play a significant role in this decision; for example, semiconductor manufacturing typically demands an ISO 5 classification or cleaner, while medical device production often requires ISO 7 or ISO 8.
Understanding the cleanliness levels needed for specific products or processes helps avoid unnecessary costs associated with over-design or the contamination risks of under-design. Additionally, consulting relevant industry standards, such as ISO standards for electronics, ensures compliance and optimal clean room function.
A gown room, or ante-room, functions as a crucial buffer zone between the cleanroom and the outside environment, allowing personnel to put on specialized clean room garments that minimize contamination risks. This space should be sufficiently large to comfortably accommodate personnel, ensuring that each individual has adequate room to put on and remove garments without compromising cleanliness.
In high-class clean rooms, airlocks or interlocks are often required to maintain positive pressure, preventing contaminants from entering when doors are opened. These airlocks or interlocks also help to stabilize air filtration before personnel proceed into the cleanroom.
For facilities with significant personnel flow, it is beneficial to divide the gowning area into distinct zones for sanitizing, garment donning, and glove application. This layout minimizes cross-contamination and supports an efficient gowning process.
Flooring is crucial in controlling a cleanroom’s particle count, impacting ease of cleaning and resistance to chemicals. Common materials like vinyl, epoxy, and sealed concrete are smooth, durable, and reduce particle shedding. In sensitive areas, such as electronics manufacturing, anti-static or conductive flooring prevents static buildup that could harm components.
For high-cleanliness environments, such as ISO Class 5 and below, raised flooring can be used to enhance laminar airflow. This design allows high efficiency particulate air to flow beneath the floor, creating a downward current that effectively removes contaminants from the workspace.
Maintaining temperature and humidity control is crucial to cleanroom functionality, as these environments often generate substantial heat from tools and HEPA filters, necessitating an effective HVAC system. Many applications require stringent temperature and humidity levels to maintain product stability.
Excessive humidity may cause condensation, while insufficient humidity can result in static electricity, both of which can compromise processes. Proper HVAC system sizing is essential, accounting for heat load from equipment, occupancy, lighting, and airflow needs.
An undersized system may struggle to meet conditions, while an oversized one can lead to high energy costs. Additionally, a well-designed HVAC system should maintain consistent temperature and humidity levels to prevent fluctuations that could disrupt sensitive processes.
Cleanroom wall surfaces must resist contamination and endure frequent cleaning without degradation or particle shedding. To meet these demands, materials like HDPE gypsum and fiber-reinforced plastic (FRP) are popular choices due to their smooth, non-porous surfaces, which support cleanliness.
For high-grade cleanrooms, more durable materials like stainless steel or static-dissipative painted aluminum are often required to help control particle levels effectively. Selecting materials that withstand rigorous cleaning and potential impacts from equipment reduces the need for repairs, minimizing disruptions and ensuring consistent cleanroom performance.
Material transfers pose a notable contamination risk in cleanrooms, making it essential to control how materials enter and exit the environment to preserve cleanliness. Pass-through chambers are ideal for small items, enabling transfers between the cleanroom and adjoining areas without requiring personnel entry, thus reducing contamination risks.
For larger items or high-traffic areas, dedicated material transfer rooms with features like motorized roll-up doors are often necessary to maintain airflow and cleanliness during equipment movement. In cases where large or frequent transfers are needed, cart transfer systems offer an efficient solution, allowing items to pass through with minimal disruption to cleanliness.
Windows, though often considered a minor feature, bring significant functional and psychological advantages to cleanrooms. For supervision, windows allow staff or supervisors to monitor cleanroom activities from outside, minimizing contamination risks.
Strategically placed observation windows are especially useful for cleanrooms that require constant external monitoring. Additionally, windows provide psychological comfort for cleanroom workers by reducing feelings of isolation and promoting a more comfortable, productive environment.
In a sector like electronics, where customer trust is critical, observation windows allow clients or visitors to observe cleanroom processes without compromising cleanliness, fostering transparency and confidence in the facility’s operations.
Lighting plays a crucial role in cleanroom design, impacting productivity, safety, and regulatory compliance. Bright, even lighting is essential to reduce eye strain and help personnel detect contaminants or product defects; LED lights are often preferred due to their clear, consistent illumination and minimal heat output.
It’s important to select sealed light fixtures to prevent dust or particles from escaping into the cleanroom, ensuring a cleaner environment and easier maintenance. Additionally, using lighting with a color temperature between 4000K and 5000K, similar to daylight, enhances visual acuity, helping workers perform tasks more accurately and comfortably.
Designing a cleanroom involves careful planning across multiple aspects to ensure it meets the cleanliness, operational, and comfort requirements of your specific industry. By following this checklist, you’ll be well-prepared to create a controlled environment that minimizes contamination, supports compliance, and provides a functional workspace for your staff.
From selecting materials and HVAC systems to planning layout and transfer solutions, every detail counts in building a cleanroom that aligns with industry standards and enhances productivity. Contact Modulus Cleanrooms to find out how we can create your perfect modular cleanroom!
