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Cleanroom Manufacturing

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Cleanroom Medical Manufacturing

Controlled manufacturing environments play an important role in medical device and packaging production where airborne particulates and contamination must be carefully managed. Janco Medical performs a range of manufacturing, assembly and packaging processes within ISO 14644-1 certified Class 7 and Class 8 cleanrooms.

Our medical manufacturing division is ISO 13485 certified and FDA registered, with cleanroom capabilities supporting projects from design and material selection through manufacturing, assembly and packaging.

Janco works with medical device manufacturers across a wide range of applications, helping determine the appropriate materials, processes and cleanroom environment based on the requirements of each project.

Cleanroom Manufacturing Capabilities

Janco’s cleanroom capabilities include:

Our team can also assist during the design and material-selection process, helping customers develop manufacturing and packaging solutions around their device, application and production requirements.

Cleanroom thermoforming is the process of forming thermoplastic materials within a controlled environment designed to limit airborne particulate contamination. For medical applications, this allows thermoformed trays, packaging and components to be manufactured under controlled conditions appropriate to the requirements of the project.

Janco performs both high- and low-volume medical thermoforming in ISO 14644-1 Class 8 certified cleanrooms. Core capabilities include thin-gauge thermoforming from .007″ to .060″, while heavy-gauge pressure thermoforming capabilities extend up to .500″.

Cleanroom thermoforming may be appropriate when a medical product or packaging system requires controlled manufacturing conditions because of its intended use, subsequent packaging process, customer requirements or applicable quality specifications.

The required cleanroom classification depends on the product, process and packaging requirements rather than on a single rule that applies to every medical device.

Cleanroom classifications define controlled levels of airborne particles within the manufacturing environment. Under ISO 14644-1, lower class numbers correspond to environments with stricter airborne particle concentration limits.

Janco uses different cleanroom classifications for different stages of medical manufacturing.

ISO Class 8 cleanrooms support Janco’s high- and low-volume thermoforming operations. Janco also maintains Class 8 certifications for medical device assembly, foam die cutting and assembly, and foam molding.

ISO Class 7 cleanrooms are used for medical packaging operations where a more tightly controlled particulate environment is required.

This allows Janco to move projects through manufacturing, assembly and packaging using controlled environments appropriate to each stage of production.

View Janco’s current cleanroom certifications on our Quality & Regulatory page.

Janco’s medical manufacturing division is certified to ISO 13485 standards and is FDA registered. Our ISO 14644-1 Class 7 and Class 8 cleanrooms are monitored and tested to verify that they continue operating within their required parameters.

Medical manufacturing processes are also evaluated through internal, independent, customer and FDA audits.

Janco’s medical device and packaging inspection team performs validation testing according to ASTM, ISO or customer-specific standards depending on the application. Products can be traced from the individual product ID back to the raw material lot number, supporting accountability throughout the manufacturing process.

Learn more about Janco’s certifications, testing and quality-management processes on our Quality & Regulatory page.

From Design to Cleanroom Production

Cleanroom manufacturing is only one stage of bringing a medical product or packaging system into production. Janco can support customers throughout the process, including design assistance, material sourcing, prototyping, manufacturing, assembly, validation and packaging.

Whether your project requires medical thermoforming, compression molding, die cutting or medical device assembly, our team can help determine how cleanroom manufacturing fits into the overall production process.

 

 

Need medical packaging done right? Let us put our decades of experience
to use bringing your solution to life in one of our ISO-certified cleanrooms.

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