Medical Manufacturing Explained: What Happens in a Class 10,000 Clean Room?

Medical devices and components for the healthcare industry often come in contact with human skin and tissues, and are even implanted in some cases. For this reason, medical manufacturing typically requires a cleaner, more sterile environment to avoid the potential for contamination that could result in diminished functionality of the product, or lead to infection or other risks for the patient. There are various technologies that medical manufacturers can employ to ensure cleanliness, and one of the most common and effective is a clean room, or cleanroom. ProMed’s manufacturing facilities, for example, are equipped with certified class 10,000 / ISO Class 7 clean rooms, demonstrating a strong commitment to quality.

What is a Clean Room in Medical Manufacturing?

Medical grade silicones are often processed in a very controlled and special facility known as a clean room. These rooms reduce the potential for contamination from dust and airborne microbes such as bacteria or viruses. Clean rooms control contaminants and air quality, and are essential to manufacturing high quality medical products. Clean rooms vary in size from large open spaces to small laboratory rooms. In addition to controlling cleanliness and contaminants, some clean rooms further control conditions such as humidity, air flow, air pressure, temperature, and electrostatic discharge.

The International Organization for Standardization (ISO) establishes the requirements for medical device manufacturing. Maintaining and operating a clean room environment to ISO standards requires excellent processes and procedures. In addition to production, clean room processing includes raw material handling as well as packaging to avoid particulates and other forms of contamination during these steps. Medical manufacturers, like ProMed, that are ISO 13485 certified have demonstrated the capability and know-how to manufacture medical devices under the requisite cleanliness and contamination controls.

Have a medical manufacturing project that requires a class 10,000 clean room?
Contact ProMed to learn more about our advanced facilities and range of silicone injection molding solutions.

What is a Class 10,000 Clean Room?

There are different levels of ISO requirements for medical manufacturing, ranging from ISO 5 to ISO 8. Most medical device manufacturing is categorized as ISO 7. Each ISO level of a clean room has a corresponding class. Clean rooms are categorized by class ranging from 100 to 100,000. The class is based on the number and size of particles permitted per volume of air. For example, an ISO 7 clean room is equivalent to a class 10,000 clean room, which means the facility must have less than 10,000 particles per cubic foot. Special filtration systems within the clean room use HEPA filters, air flow, and other measures to manage the purity of the air to ensure the necessary ISO requirements are met.

In addition to using air filtration to control cleanliness, class 10,000 clean rooms typically require personnel to wear protective equipment ranging from full bunny suits to partial coverings such as shoe covers, laboratory coats, hair nets, safety glasses, and gloves. These measures prevent human contaminants like hair, sweat, or skin from coming in contact with the manufacturing process. Clean rooms are often designed with specific wall and floor materials that are readily cleaned, as well as stainless-steel work tops and sinks. Lastly, some clean room designs include an air shower at the room entrance to reduce the level of contaminants entering the manufacturing space.

At ProMed, our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites: all are certified class 10,000 / ISO Class 7 clean rooms. Our facilities support silicone injection molding of various medical devices and components including:

About ProMed Pharma

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We have multiple manufacturing sites, all are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next LSR molding project.