Why Cleanroom Manufacturing Matters for Medical Devices
Medical devices are subject to strict manufacturing standards, and for very good reasons. The safety and cleanliness of medical equipment are vital for protecting patients and producing good health outcomes. Developing manufacturing processes to meet these standards frequently involves using a cleanroom for some or all of the steps.
Medical device cleanroom manufacturing helps ensure product safety and compliance with government regulations.
For procurement, choosing a manufacturing partner that meets these standards is critical. U.S. based, ISO 13485 certified facilities like Crescent Industries provide regulatory compliance and supply chain reliability for manufacturing medical device components.
Understanding ISO Cleanroom Classifications (ISO 7 vs ISO 8)
Not every medical device requires the same cleanroom standards.
Medical device manufacturers follow ISO cleanroom classifications. These standards set limits on the number of particles in the air. In general, the lower the ISO number, the higher the cleanliness standards.
ISO 7 cleanrooms are necessary for manufacturing Class II medical devices, such as stethoscopes and catheters. Per cubic meter of air, ISO 7 cleanroom standards require fewer than:
- 352,000 particles ≥ 0.5 microns
- 83,200 particles ≥ 1 micron
- 2,930 particles ≥ 5 microns
ISO 8 cleanrooms are sufficient for manufacturing packaging for medical devices. Per cubic meter of air, ISO 8 cleanrooms must have fewer than:
- 3,520,000 particles ≥ 0.5 microns
- 832,000 particles ≥ 1 micron
- 29,300 particles ≥ 5 microns
Key Compliance Standards
Adhering to cleanroom standards set by several governmental and non-governmental organizations is an important part of medical device quality control protocols.
The FDA regulates manufacturing processes under the 21 CFR 820 standards. These regulations require manufacturers to control and monitor their production processes, as well as maintain written documentation. The FDA also requires many medical devices to be traceable in case of a recall.
The FDA is currently working to align its production quality standards with ISO 13485, with the new harmonized regulations becoming effective February 2, 2026. ISO 13485 also regulates multiple factors in the manufacturing process, with recent revisions especially focusing on clean and sterile environments.
When choosing a medical device manufacturer, consider one that's already FDA-registered and ISO 13485 certified manufacturer to simplify compliance and audit readiness.
Cleanroom Injection Molding Workflow
The cleanroom manufacturing cycle looks like any other production cycle, but at each step, potential contamination is a serious concern. Every step of the manufacturing process introduces foreign materials such as tools and adhesives, putting the cleanroom environment at risk.
Part Design for Cleanroom Environments
Manufacturers don't have to do anything special when it comes to designing parts intended for production in cleanroom environments.
Part designers consider cost, complexity, material, and best practices when designing cleanroom parts, the same as they would for parts intended for production outside the cleanroom environment.
Tooling and Mold Build
When building a mold for plastic medical device manufacturing, manufacturers consider whether it will be used in a cleanroom environment. The molding process itself isn't an issue, but particular molds could present problems. For example, an injection mold for use in a cleanroom cannot require harsh mold release chemicals.
Injection Molding in ISO-Certified Cleanrooms
Molding can cause serious issues for medical device manufacturing. The process can release gases and particles and generate static electricity.
When choosing a cleanroom injection molding partner, consider one able to perform multiple techniques, including medical overmolding applications, in a cleanroom environment.
Cleanroom Assembly and Testing
Adhesives and welding introduce new variables into the cleanroom environment. Medical device manufacturers choose materials that will introduce the fewest number of particles into the air. They also try to reduce human handling and use automation where possible.
Packaging and Labeling
Medical device manufacturers use packaging material, such as coated plastic or solid cardboard, that doesn't introduce too many particles into the cleanroom air.
Labeling is the last step of the cleanroom manufacturing process, and it's key for maintaining proper documentation and product traceability. A thoughtful labeling process also makes data management easier down the line. Labels need to include all relevant manufacturer information.
Benefits of Cleanroom Manufacturing for Medical Devices
Medical device manufacturing cleanrooms are necessary to meet certain regulatory standards, but using them also makes a better product. Controlling environmental variables such as temperature and humidity provides consistency, while a lack of particle contamination helps with device quality.
The clear processes and thorough documentation a cleanroom requires can improve your overall efficiency by reducing scrap and making production more predictable. Detailed documentation makes audits faster and easier and provides regulators with what they need to know.
Medical Devices that Require Cleanroom Manufacturing
A wide variety of medical devices require cleanroom manufacturing, including:
- Surgical instruments
- Certain diagnostic devices
- Drug delivery systems such as syringes and IV bags
- Implant components for pacemakers and joint replacements
- Pharmaceutical containers such as pill bottles
At every level of the healthcare system, medical treatment depends on clean and reliable equipment.
Why Choose Crescent Industries for Cleanroom Manufacturing?
Crescent Industries is a trusted US-based leader in medical device cleanroom manufacturing. We have ISO 13485 certification and offer cleanroom molding along with a full service end-to-end solution including building new mold tooling, and assembly. With us, there's a lower risk of contamination, fewer vendor handoffs, and better traceability, so you know that your product is secure and meets standards.
If you need seamless project management over your regulated medical devices, contact us today to learn more about medical device injection molding, our cleanroom facilities, and how our expertise can help you improve both efficiency and product safety.
