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    Cleanroom Manufacturing Services

    Cleanrooms filter out contaminants to maintain a controlled environment for applications that require extreme cleanliness. These rooms control variables such as humidity, temperature, and airflow critical for the safe manufacture of medical devices, pharmaceuticals, and electronics. Partnering with a US-based cleanroom-capable manufacturer can help you avoid costly import or export tariffs and complicated logistics while promoting a more transparent and easy-to-monitor process.

    At HARBEC, we manufacture precision parts with tight tolerances in a decentralized ISO Class 8 cleanroom for flexible production. We also specialize in additive manufacturing and 3D printing, CNC machining, injection molding, mold making, and quality assurance for the medical market.

    Partnering With Cleanroom Manufacturing Service Providers

    Installing and operating a cleanroom requires extensive logistical planning, expertise, and resources. However, by partnering with HARBEC, you can:

    Maintain Low Energy Consumption and Expenditures

    You no longer need to design your cleanroom around your operation as you can now separate the two.

    Save on Costs Associated With Building a Cleanroom

    A high-quality custom cleanroom can cost $2 million or more to build. Having HARBEC provide such services eliminates the need to worry about maintenance costs, finding or establishing production space, hiring or training dedicated staff, or obtaining necessary certifications.

    Enable Flexible Configuration

    Our open floor plan cleanroom allows reconfiguration to meet your current or future needs. In addition, taking an on-demand approach to manufacturing services affords you greater versatility.

    Lower Staff Needs

    Our team will carefully monitor and control particulate levels and air exchanges per hour. This ensures that your manufactured components meet the highest quality standards without requiring trained cleanroom operators on your team.

    Reduce Manufacturing Time

    It takes time and planning to construct a working cleanroom. However, partnering with HARBEC can reduce your startup investments and help get your product to market more efficiently.

    Here are additional advantages of choosing HARBEC as your cleanroom manufacturing service provider:

    • No need to validate your facility.
    • No large capital expenditures.
    • No maintenance costs.
    • No need to hire skilled employees.
    • Allows the customer to focus on product development and growth.
    • Capable of expanding up to six injection molding presses for high-volume applications.

    Decentralized Cleanroom Model Overview

    Decentralized systems are beginning to overtake centralized systems due to their effectiveness and cost advantages. In a centralized cleanroom model, the injection molding machine is inside the room. When it needs maintenance, all cleanroom processes are interrupted. However, in a decentralized model, production equipment, such as injection molding machines, are located outside the cleanroom. The only operations within the room are processing, handling, inspecting, and secondary procedures. If mold maintenance is required, it can take place without interrupting these other functions.

    HARBEC’s decentralized cleanrooms include high-efficiency particulate air (HEPA) units, on the injection molding machine(s), an encapsulated conveyor, and a pass-through. The decentralized setup is easier to reconfigure in the future because it uses standard cleanroom openings for part conveyance. It also offers improved cleanliness control and lower operating costs whereas hybrid cleanrooms may have a lower initial cost but are less efficient and can be more difficult to use and adapt.

    Benefits of Decentralizing Cleanroom Manufacturing

    Decentralized cleanrooms have been popular in Europe for years. HARBEC recognizes many of the advantages, including the following:

    Reduce Contamination Concerns

    Having the machine outside the clean room removes unnecessary particulates and heat within the clean room in turn requiring less energy for operation. In addition, maintenance and operations of molding machines are conducted outside the clean room further reducing contamination risks and concerns.

    Handle Processes on Multiple Lines

    Decentralized cleanroom manufacturing can reduce downtime. If one line fails, it does not necessarily affect the others. Furthermore, having multiple lines means faster turn times and lower labor costs. If your job requires a larger or smaller molding machine, we simply swap it out with an existing machine or add it to our clean room without creating downtime for other products in production.

    Enhance Energy Efficiency

    An essential energy efficiency concept for cleanroom systems or components is to achieve the most productive work for the least amount of energy (lowest energy cost). In general, decentralized cleanrooms use less energy than centralized ones. 

    Choose HARBEC as Your Trusted Manufacturing Partner

    When your components require manufacturing and assembly in a highly controlled environment, choosing the right partner is critical. HARBEC is an award-winning ISO 13485 and a 9001-certified company that proudly practices sustainable manufacturing services. We serve customers across the US and indeed, around the world. 

    Our processes save resources and energy, with a focus on minimizing negative environmental impacts. Our ISO 50001 certification means the company is dedicated to continuous improvement and long-term sustainable manufacturing. By harnessing renewable resources such as wind, solar, and water, we operate a resilient campus designed to mitigate the risk of downtime associated with reliance on an increasingly unpredictable power grid. 

    Call us today to learn more about HARBEC’s manufacturing solutions, including secondary operations such as kitting, labeling, assembly, and packaging. 

    Contact us at (888) 521-4416 or request a quote for more information on our cleanroom capabilities.


    The Aviation Industry is highly regulated with demands and controls that ensure the safety and reliability of equipment and materials. Our aviation, space and defense customers can be confident that HARBEC retains a certified Quality Management System which is well implemented and designed to deliver increased customer satisfaction as a natural by-product of tracking key quality goals of on-time delivery and compliant product to our customers. Our processes are monitored to improve efficiency, ensure product safety and reliability while continually improving.

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    The Medical Industry is highly regulated with demands and controls that ensure regulatory requirements and customer expectations are met. Our medical device customers can be confident that HARBEC retains a certified Quality Management System which is well implemented and designed to deliver increased customer satisfaction as a natural by-product of tracking key quality goals of on-time delivery and compliant product to our customers. Our ISO 13485 management system adopts a risk management approach which, while having these controls in place, eliminates hazardous situations throughout the product realization process.

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    HARBEC is a registered ITAR company. International Traffic in Arms Regulations (ITAR) is a set of United States Government regulations on the export and import of defense related articles and services. Our Defense and Military customers can have complete confidence that HARBEC has an established and implemented ITAR compliance program and adhere to the strict guidelines set forth by ITAR and EAR statutes.

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