“Creating a cleanroom environment here at PDI has been a long-time desire. Not only does it allow us to showcase our products, but it also allows our clients the benefit of seeing our products at work in the environment with which they are intended and designed for. Additionally, with the launch of our new Teflon Pure Fluid Assembly division, having a cleanroom is crucial to the process. All of the product assemblies and weldments within this division are tested, cleaned, bagged, and tagged in our Class 10000 cleanroom.”
Daryl Flynn – CEO
At Plastic Design, Inc., we are excited to announce the addition of a state-of-the-art Class 10000 cleanroom as part of our new PFA/Teflon division at our expanded facility in Nashua, NH. This major upgrade is more than just a facility enhancement; it streamlines our production process, improves product quality, and gives clients the peace of mind that their products are being produced in the best possible environment. Here, we’ll dive into the details of Class 10000 cleanrooms, including their importance, benefits, applications, and more.
What Is a Class 10000 Cleanroom?
A Class 10000 cleanroom, also known as an ISO 7 cleanroom, maintains an environment that limits the number of airborne particles to no more than 352,000 particles per cubic meter of air, each measuring 0.5 micrometers or larger. These cleanrooms are essential for industries where even the smallest contaminant can significantly impact product quality. By maintaining strict control over airborne particulates, Class 10000 cleanrooms ensure that critical production and assembly processes occur in an environment free from contaminants.
Why Class 10000 Cleanrooms Matter
Industries such as pharmaceutical manufacturing, biotechnology, microelectronics, and more rely on Class 10000 cleanrooms to maintain product integrity and adherence to strict regulatory standards. At Plastic Design, Inc., these controlled environments are critical to our new Teflon Pure Fluid Assembly division, where products undergo thorough testing, cleaning, bagging, and tagging, all within the contaminant-free confines of our Class 10000 cleanroom.
Key Design Essentials for Class 10000 Cleanrooms
Maintaining a Class 10000 cleanroom requires careful consideration of airflow, filtration, and surface materials.
Airflow and Filtration Requirements
Within a Class 10000 cleanroom, airflow and filtration are critical. HEPA (High-Efficiency Particulate Air) filters, which are capable of removing 99.99% of particles as small as 0.3 microns, are commonly used to achieve the required air purity levels. Additionally, these cleanrooms should have 60 to 90 air changes per hour to maintain cleanliness and prevent contamination.
Material Selection for Cleanroom Surfaces
Surface materials used in a Class 10000 cleanroom should be smooth, non-porous, resistant to microbial growth, and easy to clean to prevent particle buildup. For walls, materials such as coated steel or PVC are commonly used, while floors are commonly made with seamless vinyl or epoxy coatings to keep the environment sterile.
Critical Equipment for Class 10000 Cleanrooms
Class 10000 cleanrooms are typically equipped with various types of specialized furniture and fixtures to help maintain cleanliness and functionality.
Gowning Stations and Storage Solutions
Gowning stations are crucial for preventing human-borne contamination. Gowning areas for Class 10000 cleanrooms should include garment racks, bootie dispensers, and glove dispensers to allow employees to don the appropriate attire prior to entering the cleanroom. An efficient layout will promote unidirectional flow to decrease the risk of contamination.
Essential Cleanroom Furniture and Fixtures
Furniture and fixtures within a Class 10000 cleanroom should be designed for easy cleaning and minimized particle generation. Polypropylene and stainless steel materials are often preferred for their ease of sterilization and durability. Ergonomic workbenches, mobile carts, shelving units, and more are often incorporated to improve worker productivity while maintaining hygiene standards.
Industry Applications of Class 10000 Cleanrooms
Class 10000 cleanrooms are used across diverse industries that have strict cleanliness requirements.
Biomedical and Pharmaceutical Uses
In the biomedical and pharmaceutical industries, Class 10000 cleanrooms are essential for tasks like vaccine production and drug formulation. These controlled environments ensure compliance with Good Manufacturing Practice (GMP) and FDA standards by maintaining sterile conditions essential for product quality and safety.
Microelectronics and Semiconductor Manufacturing
In microelectronics, Class 10000 cleanrooms are critical for assembling sensitive components, such as surface-mount technology (SMT) and printed circuit boards (PCBs). Even minute contamination can lead to defects, so a sterile environment is important in ensuring the reliability and functionality of products.
Discover the Benefits of Our Class 10000 Cleanroom for Your Business
At Plastic Design, Inc., the addition of our Class 10000 cleanroom is a long-awaited milestone that enhances our commitment to product quality and safety. This cleanroom not only allows us to showcase our products in their intended environment, but it also gives our clients a unique opportunity to see how their products are produced and assembled.
With the introduction of our Teflon Pure Fluid Assembly division, the cleanroom plays a vital role in ensuring all assemblies and weldments are thoroughly tested, cleaned, bagged, and tagged within a controlled environment. This guarantees that every product meets the strictest quality standards before it reaches our clients.
We invite you to our facility to see firsthand how our Class 10000 cleanroom supports our production processes. To discover how this cleanroom can help meet your unique needs, contact us for a quote today.
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