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Medical device cleanrooms engineered for compliance

Precision and sterility are non-negotiable in medical device manufacturing. At Encompass Cleanrooms, we deliver contamination-controlled environments that help you meet FDA, ISO, and GMP requirements while protecting product integrity and patient safety.

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Meet stringent medical manufacturing standards

From surgical instruments to implantable devices, even the smallest trace of contamination can jeopardize a product’s safety and effectiveness. Cleanrooms are essential to medical device manufacturing, enabling you to meet strict regulatory standards and produce devices with the precision and sterility required for healthcare applications.

Encompass Cleanrooms designs and builds clean environments typically ranging from ISO Class 5-8, depending on the process and product. Our cleanrooms are engineered for high performance and full compliance with regulatory agencies and standards.

 

Supporting safe, sterile medical device production

Medical device cleanrooms are built to control bioburden, particulates, and microbial contamination throughout every stage of production. We design clean environments that protect your processes and patients.

Device assembly & packaging

Cleanrooms ensure contamination-free assembly and sterile packaging of critical medical devices, reducing the risk of infection and improving product shelf life.

Diagnostic & monitoring equipment

From glucose monitors to imaging systems, cleanrooms prevent microscopic defects or debris from impacting performance and calibration.

Implantable & invasive devices

Strict contamination control is essential when manufacturing stents, catheters, or orthopedic implants. Cleanrooms help ensure biocompatibility and patient safety.

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Cleanrooms for every medical device manufacturing process

We offer flexible cleanroom solutions that align with your product classification, regulatory needs, and manufacturing volume. Our hardwall and rigidwall cleanrooms are both proven choices for medical environments.

Hardwall cleanrooms:

Ideal for the most stringent ISO classifications and validated processes. These sealed systems support high levels of airflow control and offer long-term durability for intensive production.

Rigidwall cleanrooms:

A clear panel, cost-effective option for ISO Class 5–8 environments. Rigidwall systems are fast to install and easy to modify, making them ideal for device assembly and inspection areas.

Regulatory expertise in medical device cleanroom design

We bring deep experience in cleanroom design for agency-regulated manufacturing. Our team understands the critical standards that govern the medical device industry and will ensure your facility is built for inspection readiness and long-term compliance.

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Ongoing support for compliant operations

Cleanrooms used in medical device manufacturing require regular validation and environmental control. Encompass offers turnkey cleanroom maintenance services—including filter replacement, particle monitoring, air balancing, and microbial testing—to help you stay compliant and avoid costly downtime.

We partner with you beyond installation to ensure your cleanroom continues meeting all expectations year after year.


Trusted experts in medical device cleanroom design

Turn to Encompass for cleanrooms engineered to meet the strictest standards in medical manufacturing. We design for safety, compliance, and long-term performance.