ISO 13485 Certified Cleanroom Die-Cutting
Does your custom die-cut medical or consumer wearable product or sensitive electronics assembly require a cleanroom manufacturing environment? Do you commonly have product requirements that include terms like HEPA filtration, humidity and temperature control, and static mitigation? Are extremely tight tolerances, island placement, and multiple layers of construction must-haves?
JBC Technologies operates ISO 8 / Class 100,000 certified clean rooms purpose-built for these requirements. With dedicated high-speed rotary die-cutting presses, inline lamination, and automatic defect detection, JBC delivers cleanroom quality at production scale
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Clean Room Processing
Capabilities Overview
JBC Technologies operates ISO 8 / Class 100,000 certified clean room manufacturing environments that meet the strict quality and contamination control requirements of regulated industries. We support medical device manufacturers who require documented, validated converting processes for wound care, wearable diagnostics, surgical components, and skin-contact adhesive products, as well as aerospace, electronics, automotive, and industrial customers that need strict particulate control.
Our ISO 13485 and ISO 9001: 2015 quality systems support traceability, lot documentation, and regulatory submission support.
From materials handling to finished parts, our controlled processes are designed to minimize airborne particulates, static, humidity, and temperature fluctuations—reducing rejections and assembly risk.
Industries Served Include:
Clean Room Die-Cutting Benefits Quality. Consistency. Control.
A cleanroom is about control, and through this control, the elimination of potential failure modes brought by the manufacturing environment itself. We effectively control the air quality, humidity levels, static charge, and temperature of our ISO 8/ Class 100,000 clean room, and as a result, we’re able to repeatably produce, package, and assemble large volumes of high-quality, sensitive die-cut parts and components.
Our Cleanrooms Feature...
Rotary Die-Cutting
Precisely die-cut complex parts to tight tolerances in a controlled cleanroom environment. Ideal for medical and electronic applications where accuracy and low particulate levels are essential to product integrity and performance. Our high-end presses also feature automatic defect detection.
In-line Lamination
Bond multiple materials together and produce complete multi-layer die-cut components in a single pass. We match the production environment to your application requirements — including cleanroom processing for projects where contamination control is critical.
Island Placement
Deposit discrete adhesive segments or die-cut components at exact locations across the web, placing material only where it is needed. Ideal for wearable devices, wound care products, and skin-contact components where placement accuracy and adhesive integrity directly impact performance and patient safety.
Packaging
Finished parts and products can be packaged directly within our cleanroom environment, eliminating the risk of contamination between production and shipment. This is a critical step for medical, wearable, and electronic applications with strict cleanliness requirements.
Ask An Engineer: Clean Room Die-Cutting FAQs
We have certified ISO Class 8 clean rooms. These are maintained and monitoring by following our established processes and procedures in accordance with ISO and FDA regulations.
An ISO 8 Cleanroom delivers a controlled manufacturing environment designed to limit airborne particulate contamination. It is ideal for products that require moderate cleanliness, such as many FDA Class I medical device components and other non‑sterile assemblies.
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Up to 3,520,000 particles per m³ ≥ 0.5 μm
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Up to 29,300 particles per m³ ≥ 5.0 μm
We have a lot traceability process that is customized and implemented on a part-by-part basis. COC and COA are generated based on the quality requirements of the customer.
Any 'clean' type of material that doesn't generate a lot of external particulate and debris. Most medical grade materials and adhesives are common.
This is dependent on the material and the geometry of the subject part, but generally speaking we can see tolerancing around the +/- 0.03125"(1/32") mark. We can hold tighter than that, but there are some dependencies to do so.
Yes, we offer clean room packaging as well as converting to support some of the post processing needed for some of these clean applications.
Yes we offer a variety of kitting support within the clean room, whether it's as simple as kitting or as complicated as highly customized packaging.
Following standard ISO procedures plus some to ensure quality parts. A quality plan for every part is developed, documented, and implemented based on the risk of the part in question. The quality systems we use, and the inspection/detection plan are assigned upon risk assessment on the initial part setup.
JBC Technologies Clean Room A Controlled Manufacturing Environment
JBC Technologies is a leader in providing the highest-quality die cutting and material converting solutions for industries including medical, electronics, automotive, and more. If your project requires parts that are free of foreign particles, contact JBC to discover how our clean room capabilities can help.