Cleanrooms and Innovation: The Cornerstone of Plastic Manufacturing for Medical Devices and Products

August 03, 2025 • 5 min read

From prescription pill bottles to contact lens cases, everyday medical products play an important part in our lives that we often take for granted. We depend on these products to keep our medications and medical devices safe, so they must be designed and manufactured with sterility in mind from the start. 

Why a Cleanroom is Important When Manufacturing Medical Devices and Products

Medical devices, products, and medical packaging need to maintain strict hygiene standards in order to serve patients safely. Sterilization offers one way to eliminate bacterial contamination; however, it doesn’t eliminate other potentially harmful particles in the air. These contaminants can put the end user and medical provider at risk, as well as endanger those developing the product. To address this, certain high-risk products are manufactured in specially designed cleanrooms. These facilities offer a highly controlled environment in which injection-molded plastic and other products can be manufactured to meet the highest standards of cleanliness.

Cleanrooms work by filtering pollutants like dust, ink flakes, aerosol particles, hair, and even small insects out of the area. These rooms also provide temperature, airflow, and humidity control to further ensure that medical products and devices can be made to their exact hygiene specifications. When working in a cleanroom, personnel are required to wear special equipment such as clean suits, gloves, masks, and shoe covers to minimize the risk of introducing harmful pollutants into the environment. To further reduce the risk of transferring contamination into the area, each cleanroom also has strict entry and exit procedures that each individual must follow.

Medical packaging cleanrooms are specifically designed to ensure the safe production of medical-grade products. These facilities are highly monitored to comply with internationally recognized ISO Class 5-8 standards. Along with maintaining cleanliness, these regulations help systematize processes in the product development cycle, ensuring that the products meet strict industry standards. This means products produced in one ISO Class 8 facility will match the quality of those produced in another.

With these guidelines and safety features in place, cleanroom plastic manufacturing allows the healthcare industry to achieve a higher level of quality control, cleanliness, and ultimately, patient satisfaction.

How Alltrista is Setting the Bar High for Medical Packaging

At Alltrista, we see material science as a powerful catalyst for innovation and the creation of better futures. Our goal is to develop products that simplify and enhance everyday life. With expertise in design, engineering, and manufacturing, we help clients transform their ideas from concept to commercialization — driving progress in the most regulated markets, including healthcare.

Here’s how we set the bar higher in innovative, collaborative plastic manufacturing.

Our Cleanroom Standards
Over the past several decades, rigid plastic packaging solutions for medical devices and products have become much more complex. To keep up with evolving practices and ensure the best quality for our customers, we’ve invested in top-of-the-line cleanroom technology. 

We currently operate class 7 and 8 cleanrooms to facilitate the production of our custom plastic molding solutions. Our cleanrooms allow us to deliver high-quality end products while maximizing efficiency at the same time. Key features of our cleanrooms include:

• Micron-level precision to maintain a sterile environment
• Temperature-controlled metrology laboratories to produce the most accurate, reliable measurements
• 60 air changes per hour of HEPA-filtered air
• High cavitation with high precision to boost efficiency

With our commitment to quality assurance, we’re able to offer our customers tailored, custom, and scalable solutions that fit unique use cases - without impacting quality and performance standards.

From Concept to Commercialization

Our cleanroom standards aren’t the only thing that sets Alltrista apart. Whatever ideas you bring to the table, we’re ready to bring them to life. Our team’s product development process begins with collaboration at the forefront. We act as trusted advisors, listening to our clients and working quickly to help turn your problems into actionable solutions. We get to know your specific needs so we can tailor products that are lighter, more efficient, and less wasteful. This way, we’re able to deliver solutions that protect your products and your customers.

To ensure all Alltrista^® medical devices, packaging, and products are made to the highest standard, we use cleanrooms as a part of our strict plastic manufacturing process. By making safety and cleanliness a top priority, we’re able to make healthcare better in both hospitals and homes.

At Alltrista, we focus on the details from concept to commercialization so that our healthcare customers can make a big difference. Contact us today to explore our suite of custom medical packaging solutions.