Cleanrooms for Medical Device Manufacturing & Packaging

Medical device manufacturing and packaging requires absolute precision and an incredibly high level of cleanliness. Even the smallest particle, microorganism, or environmental fluctuation can compromise the safety and effectiveness of the devices that will eventually come into contact with patients. 

To safeguard quality and compliance, manufacturers rely on medical device and medical packaging cleanrooms, specialized environments designed to maintain the most stringent contamination control standards. 

What Are Medical Device Cleanrooms & What Processes Take Place In Them?

In the medical industry, cleanrooms function as highly controlled environments that regulate airborne particles, microbial levels, humidity, and temperature. Devices like instruments, implants, diagnostic tools, and drug delivery systems are all manufactured in cleanrooms to prevent contamination. 

Beyond production, cleanrooms also play an important role in assembly, sterile packaging, and specialized processes. For manufacturers that need a large volume of plastic components, cleanrooms can also house injection molding processes to produce parts without particulate interference.

ISO Classifications for Medical Device and Packaging Cleanrooms

Not all medical devices and packaging operations require the same level of contamination control. Therefore, cleanroom classifications vary depending on the criticality of the device/packaging and its intended use. The most common ISO classifications for these cleanrooms are: 

• ISO Class 5: Cleanrooms designed for the highest-risk devices, including surgical tools and implantable devices. They provide ultra-low particulate levels to meet the strictest standards. 
• ISO Class 7-8: Cleanrooms typically used for semi-critical or non-critical devices, such as external tools or equipment that may not come into direct contact with a human body. These are also the most typical ISO classes used for medical packaging operations.

The level of sterility needed directly correlates with patient safety. As a result, cleanroom design and construction must align with ISO standards and FDA regulations to ensure proper compliance.

Additional Medical Device Cleanroom Standards and Requirements

The U.S. Food and Drug Administration (FDA) further categorizes devices into three classes based on risk level and the level of control needed: 

• Class I Devices: Considered low-risk, these include tools like handheld surgical instruments. While they need a clean environment, their contamination control needs are less stringent than some others.
• Class II Devices: These are moderate-risk devices like infusion pumps or catheters. Manufacturing must meet higher cleanroom requirements with strict quality assurance measures in place.
• Class III Devices: These are high-risk, life-supporting, or life-sustaining devices like pacemakers and prosthetic heart valves. They require the most stringent controls, often manufactured in ISO Class 5 cleanrooms where sterility and environmental control are paramount.

Hardwall, Softwall, or Rigidwall: Which Type of Cleanroom Is Best for Medical Device Manufacturing and Packaging?

For medical device manufacturing and packaging, hardwall cleanrooms are the gold standard. Unlike softwall or rigidwall structures, hardwall cleanrooms provide permanent enclosures that deliver superior environmental stability. They are capable of maintaining the consistent pressure, temperature, and humidity needed.

Hardwall cleanrooms also offer flexibility for integration with processes like injection molding, while maintaining compliance with relevant ISO standards. They can be constructed with modular components, which can also keep the door open for future expansion if needed.

Build Your Medical Device or Medical Packaging Cleanroom with Encompass

The medical industry leaves no room for error. From injection molding plastic parts to packaging life-sustaining devices, every stage requires a low-contaminant environment that ensures patient safety and regulatory compliance. By aligning cleanroom design with ISO and FDA classifications, manufacturers can maintain the sterility, precision, and quality demanded from modern healthcare. 

At Encompass Cleanrooms, we specialize in designing and building medical device and medical packaging cleanrooms that meet the highest standards of performance and compliance. To begin your project, get in touch online.