Clean Room Capabilities

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ISO Class 7 Clean Room (Certified):
This high-grade clean room is specifically designed for the assembly and packaging of implantable medical devices destined for terminal sterilization. With stringent control of airborne particulates, pressure, temperature, and humidity, our ISO Class 7 environment meets the cleanliness levels necessary for high-risk medical components. All workflows follow rigorous gowning, documentation, and material handling procedures to ensure sterility chain integrity and FDA compliance.

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ISO Class 8 Clean Room (Certified):
Our ISO Class 8 clean room is ideal for the assembly of non-implantable medical devices or components that require a controlled, but slightly less stringent, clean environment. It supports a wide range of applications from intermediate subassemblies to final device packaging, providing reliable contamination control and process repeatability for high-throughput production.

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Supervised Controlled Environment (ISO Class 8 Standards):
For clients who need ISO Class 8-level cleanliness without the overhead of managing and certifying their own clean room space, we offer access to a D&R-supervised clean room that adheres to ISO Class 8 standards. This flexible solution allows you to scale production quickly while maintaining confidence in environmental control, cleanliness, and traceability. Our trained staff manage room protocols, materials flow, and equipment sterilization to reduce your internal burden and regulatory exposure.

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All clean room environments are validated and monitored quarterly by an accredited third-party agency to ensure full compliance with ISO 14644-1 standards and current Good Manufacturing Practices (cGMP).

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Medical Device Packaging Services

 

D&R also offers turnkey packaging solutions that meet the complex demands of the medical device industry. Our packaging services are fully integrated with our clean room operations and include:

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• Medical-Grade Pouching and Sealing: Heat-sealed Tyvek® and polyethylene pouches designed for sterility maintenance through EtO or gamma sterilization.

• Custom Tray Packaging: Rigid or thermoformed trays with medical-grade film sealing for implantable or delicate devices.

• Labeling and Traceability: Application of UDI-compliant labels, lot/batch coding, and barcoding, all managed under strict quality control procedures.

• Protective Kitting: Customized kitting for surgical sets or multi-component devices, packaged to ensure part integrity and reduce surgical site prep time.

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Sterilization Logistics Support

To streamline your supply chain and reduce time-to-market, D&R also offers support for downstream sterilization processes. While we do not perform sterilization in-house, we coordinate directly with certified third-party sterilization partners (EtO, Gamma, or e-beam) to:

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• Prepare devices and packaging for sterilization compatibility.

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• Ensure proper documentation and pre-sterilization validation.

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• Manage scheduling, shipping, and regulatory paperwork to meet deadlines.

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We act as an extension of your team, helping you meet stringent regulatory timelines while maintaining the quality and traceability of your product from clean room to sterilization to final distribution.

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Whether you're launching a new implantable product, scaling production of surgical devices, or optimizing your contract manufacturing pipeline, D&R Products delivers the clean room infrastructure, packaging expertise, and regulatory alignment you need—under one roof.