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Cleanroom Assembly Companies

Last updated: January 2026

This directory lists 83 cleanroom assembly companies across the United States, from contract manufacturers specializing in high-volume medical disposables to precision integrators for aerospace components.

Buyers leverage these facilities to solve critical challenges where product integrity is paramount. This includes preventing contamination in sensitive medical devices, safeguarding microelectronics from ESD damage during intricate assemblies, and ensuring sterility for pharmaceutical packaging components. The fundamental problem addressed is the need for an environment where particulate contamination, ESD events, and bioburden are stringently controlled below acceptable thresholds, often requiring specific ISO 14644 classifications and humidity regulation.

The cleanroom assembly landscape features diverse supplier types, each with distinct specializations. Some excel in high-volume, automated assembly lines for single-use medical products within an ISO Class 7 environment, while others focus on low-volume, high-mix precision integration of optics or semiconductors in an ISO Class 5 cleanroom. Distinguishing factors often include their core end-market expertise (e.g., medical, aerospace, defense, pharma), their capability for advanced Validation Master Plans, and their internal tooling and molding support for vertically integrated solutions.

83 companies·57 emails·75 phones

Company Directory

83 companies nationwide

Santa Ana, CA

Based in Santa Ana, CA, Abtech Inc. manufactures, designs, builds, and installs prefabricated and custom modular cleanrooms. They provide hardwall and softwall solutions with precise temperature and humidity control, meeting ISO Class 1-8 standards. Abtech serves the precision manufacturing, biological, semiconductor, aerospace, and food processing industries.

ACH Engineering delivers cleanroom solutions for the biotech industry, specializing in creating controlled environments for biotech research and manufacturing. The company provides services to establish and maintain high-performance biotech cleanrooms, ensuring adherence to strict industry standards for quality and safety requirements.

Clayton, NC

Based in Clayton, NC, AdvanceTEC specializes in design-build integrated project delivery for biotech cleanrooms. The company delivers cGMP cleanrooms for various clients, continually driving innovation and growth in the cleanroom sector. They recently unveiled a new innovation center.

Charlottesville, VA

Based in Charlottesville, VA, Afton Scientific provides end-to-end aseptic manufacturing and fill-finish services for pharmaceutical products. Specializing in sterile filling and processing of biologics and small molecules, the company ensures product integrity and robust regulatory compliance from its FDA-inspected facilities.

Garden Grove, CA

Based in Garden Grove, CA, Airborne Assembly provides mechanical and sub-assembly services for aerospace, aviation, and defense industries. Capabilities include riveting, helicoil and threaded fastener installation, bushing installation, and bearing installation. The company emphasizes quality clean work and quick turnaround for both complex and simple assemblies.

Houston, TX

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer of medical devices and components. The company operates a state-of-the-art manufacturing facility, offering vertically integrated solutions to shorten time to market.

Orange, CA

Allied Cleanrooms provides modular cleanroom solutions designed to meet compliance standards for various industries. They serve sectors like pharmaceutical, aerospace, healthcare, food and beverage, animal health, semiconductors, and medical devices nationwide.

Sarasota, FL

Based in Sarasota, FL, American Photonics provides cleanroom assembly services for sensitive optics. The company operates a dedicated cleanroom facility, using specialized tools to minimize damage risk during assembly. They focus on ensuring precision and quality for critical photonics components, delivering reliable optical assemblies.

San Carlos, CA

American Prototype & Production, Inc., based in San Carlos, CA, provides precision manufacturing for science and industry. Specializing in scientific instrumentation, R&D, and semiconductor capital equipment, they offer machining, part marking, and clean room packaging. Their services support medical devices and life sciences.

Rochester, NY

Based in Rochester, NY, ArcWorks provides precision Class 7 cleanroom assembly services, operating advanced ISO 7 cleanrooms. The company offers ISO 9001:2015 certified contract manufacturing and packaging, including poly bagging and Amazon FBA prep, for industrial and commercial clients.

Carolina Components Group provides cleanroom assembly services, specializing in single-use assemblies for critical fluid projects. They operate state-of-the-art cleanroom facilities, offering solutions for ultra-pure applications. The company also delivers design, consulting, hose labeling, and asset management to biotech, pharmaceutical, and personal care manufacturers.

Rancho Santa Margarita, CA

Based in Rancho Santa Margarita, CA, Class One Cleanroom Systems, Inc. designs, manufactures, and installs prefabricated and modular cleanrooms. They produce cleanroom wall systems, fan filter units, HEPA filters, and LED lighting, offering comprehensive services like layout, construction, testing, and ISO certification to meet specific project requirements.

Canton, MI

Based in Canton, MI, Clean Air Technology provides turnkey design, engineering, fabrication, and installation of ISO Class 1 to 9 modular cleanrooms. They also build dryrooms, softwall cleanrooms, and custom HVAC equipment, serving pharmaceutical, aerospace, medical, defense, and biotech industries.

Costa Mesa, CA

Clean Packaging Solutions LLC, based in Costa Mesa, CA, offers cleanroom assembly services, specializing in medical device assembly and kitting. Within ISO-certified cleanrooms, they provide contract manufacturing support, including sterile barrier packaging and quality inspection for medical, pharmaceutical, and high-tech industries.

Chino, CA

Based in Chino, CA, Cleanroom Logic designs, builds, and installs modular and structural cleanrooms. The company provides high-quality cleanroom construction for pharmaceutical, semiconductor, food processing, manufacturing, medical, and research and development industries.

Corona, CA

Based in Corona, CA, Cleanrooms By United specializes in designing, manufacturing, and installing custom modular and prefab cleanrooms. They provide ISO classes 5-8 cleanroom solutions, including those for electronics assembly, compliant with ISO 14644-1 standards. Services encompass engineering, manufacturing, and nationwide installation for industrial applications.

Solon, OH

Swagelok Cleveland | Columbus | Charleston Sales and Service Center provides ISO-certified clean room fabrication services for high-purity component assembly. They specialize in custom fluid system solutions and fluid management, offering expertise to build complex fluid system assemblies to meet unique industrial challenges for their customers.

Menlo Park, CA

Control Plastics, Inc., based in Menlo Park, CA, provides custom plastic injection molding, metal components, and comprehensive assembly services. Specializing in medical, military, and electronics industries, they offer prototyping and production with ISO 9001, ISO 13485, and FDA registration. Capabilities include injection molds, casting, and metal shaping for complex parts.

Elk River, MN

Cretex Medical offers contract manufacturing and engineering services for the medical device industry. They provide comprehensive assembly and kitting capabilities, taking projects from components to finished devices. With robust quality systems, ISO 13485 certification, and FDA registration, Cretex ensures reliable production from launch to scale.

Fort Worth, TX

Based in Fort Worth, TX, DesignPlex Biomedical LLC provides contract manufacturing services for FDA Class II and III medical devices. Specializing in precision prototyping, design development, and GMP cleanroom manufacturing, the company utilizes cleanroom workstations and ISO 13485-compliant labs. They offer comprehensive device engineering and assembly capabilities.

Paso Robles, CA

Based in Paso Robles, CA, Eagle Medical Inc. specializes in contract manufacturing, assembly, and packaging services for medical products. They provide sterilization solutions and new product introduction support, adhering to ISO 13485:2016 standards for prototypes and clinical trial units.

Tustin, CA

Based in Tustin, CA, EXPERT-EMS provides comprehensive contract electronic manufacturing (CEM) services. They specialize in PCB assembly, cable and wire harness manufacturing, and box build for complex electronic assemblies. Serving industries such as aerospace, medical, life sciences, military, and electric vehicles, EXPERT-EMS offers high-quality solutions from prototypes to medium-volume production.

College Station, TX

Based in College Station, TX, G-CON Manufacturing specializes in delivering prefabricated POD® Cleanrooms and modular cleanroom components. They provide scalable and sustainable environments essential for critical manufacturing processes across various industries, ensuring high-quality and controlled production facilities.

Mequon, WI

Based in Mequon, WI, GMI Solutions specializes in electro-mechanical assembly and embedded computing for application-critical products. The ISO 13485 certified company serves OEMs in healthcare, life sciences, oncology, automation & controls, and test & measurement markets.

San Jose, CA

Based in San Jose, CA, Green Circuits provides rapid prototyping, NPI, and production manufacturing for high-density PCB assembly, BGA rework, and complete system builds. They operate in ESD-controlled environments, holding certifications including AS9100D, ISO 13485, and J-STD-001 for space and military applications.

Buffalo, NY

Harmac provides fully integrated packaging and sterilization services for customers needing safe, sterile, and market-ready products. The company's operations support product delivery in controlled environments, ensuring compliance and quality standards for various industries.

Innovent Technologies specializes in cleanroom assembly services, adhering to stringent SEMI standards for high-quality production. From initial testing to final packaging, the company provides comprehensive solutions for demanding projects. Based in Peabody, MA, they partner with clients requiring advanced cleanroom manufacturing capabilities.

Gardena, CA

Based in Gardena, CA, Intelligent Optical Systems (IOS) specializes in the assembly and integration of complex optical and photonic systems. The company provides precision alignment, bonding, packaging, and testing services utilizing cleanroom environments for sensitive operations, serving defense, aerospace, and medical industries.

New Richmond, WI

Based in New Richmond, WI, Isometric Micro Molding offers ultra-precision micro automation and assembly services. With over 15 years of expertise, they specialize in producing micro medical devices and micro automated assemblies. The company capably handles micro-sized parts and larger components requiring intricate micro features and tight tolerances.

Holland, MI

JR Automation specializes in high-precision, high-speed assembly and inspection of small, micro, and nano components. With advanced automation expertise, the company provides comprehensive assembly services for complex parts, serving industries that demand strict environmental control and accuracy for critical applications.

Costa Mesa, CA

Based in Costa Mesa, CA, Lambda Research Optics specializes in critical opto-mechanical assembly services. The company operates a 10,000 class clean room, providing precision assembly capabilities for sensitive optical components and systems. They cater to industrial clients requiring high-standard, controlled environment manufacturing.

Saint Charles, MO

Based in Saint Charles, MO, Logic Material Handling designs, equips, and installs custom pre-engineered cleanroom buildouts. They provide turnkey engineered solutions for industrial structures, material handling, and automation systems, serving manufacturing, distribution, and warehousing. The company enhances productivity and material flow efficiency for businesses nationwide.

Minneapolis, MN

Based in Minneapolis, MN, MDI offers contract medical device assembly and kitting services for the healthcare sector, including OEM manufacturers. The company is ISO 9001 and ISO 13485 certified, and FDA-registered, providing flexible, quality-certified production solutions essential for sensitive medical products.

Somerset, NJ

Based in Somerset, NJ, MICRO is an FDA and ISO 13485 certified contract manufacturer specializing in finished medical devices and complex handheld assembly. They provide full-service product development and manufacturing, including ISO Class 8 cleanroom assembly and R&D engineering solutions.

Denver, CO

Based in Denver, CO, Modular Cleanrooms offers various designs for modular, softwall, and hardwall cleanrooms. The company provides complete cleanroom solutions, including HEPA filters, components, furniture, and supplies for diverse industries, with specialized designs like the Micro-Clean for medical applications.

Norman Noble, Inc. provides advanced contract manufacturing for medical implants and components. They offer final cleaning, assembly, welding, and packaging services within an ISO Class 7 cleanroom, certified to ISO 14644-1. Specializing in challenging nitinol and orthopedic designs, their capabilities include laser processing, micro milling, and turning.

Oakwood Village, OH

Oakwood Labs, an FDA-approved cGMP manufacturing facility, specializes in aseptic manufacturing of clinical and commercial products. They provide full capabilities from R&D through GMP for projects like long-acting injectables, utilizing a patent-protected manufacturing process.

Roanoke, VA

P1 Technologies, based in Roanoke, VA, is a contract manufacturer with 75+ years of experience. They offer comprehensive in-house capabilities including cleanroom and sterile barrier packaging. The company provides custom cable assemblies, precision molding, and rapid prototyping for medical, defense, and audio industries.

PEKO Precision Products offers class 1000 (ISO 6) cleanroom assembly services for OEMs, ensuring high technical accuracy in contamination-free environments. This full-service contract manufacturer specializes in complex mechanical and electromechanical assemblies, custom machinery, and turnkey equipment. PEKO supports the medical, semiconductor, and defense industries.

Redlands, CA

Based in Redlands, CA, Precision Hermetic Technology engineers and manufactures high-quality glass-to-metal seal hermetic products and reliable connectors. Since 1989, PHT has supported diverse applications for aerospace, defense, and medical industries, providing mission-critical leak-proof solutions.

Precision MicroFab LLC delivers micro-manufacturing solutions for medical, life sciences, microelectronics, and aerospace industries. They offer micro-device design, build, and R&D for assembly of micro-manufactured parts. Capabilities include precision laser cutting, drilling, micro-molding, welding, and soldering, ideal for sensitive applications requiring controlled environments.

Santa Fe Springs, CA

Pro-Tech Design & Manufacturing offers comprehensive medical device contract assembly and packaging services. An FDA & ISO 13485 registered company with over 40 years of experience, they provide end-to-end solutions. Services include sewn medical products, laboratory, and sterilization from facilities in California, Minnesota, and Texas.

Lake Mary, FL

Based in Lake Mary, FL, Quality Manufacturing Services is a full-service electronics manufacturing provider specializing in PCB assembly and prototyping. The company holds ISO 13485 certification for medical devices, demonstrating a commitment to stringent quality management and frequently operating cleanroom environments for sensitive product assembly.

Henrietta, NY

Rochester Precision Optics (RPO) is a US-based manufacturer specializing in advanced optical and electro-optical assembly, operating over 40,000 sq. ft. of Class 10,000 cleanroom space. RPO provides design, engineering, precision glass molding, diamond turning, machining, and thin film coating services for various applications.

Fremont, CA

Based in Fremont, CA, Sonic Manufacturing Technologies is a contract manufacturer specializing in PCBA, box build, and system integration services. The company operates a Class 10,000 / ISO Class 7 Cleanroom facility, dedicated to the assembly of medical devices and other sensitive electronics, ensuring contamination-sensitive projects meet strict quality and environmental standards.

Yorba Linda, CA

Based in Yorba Linda, CA, SpecialTeam is an ISO 13485:2016 registered facility specializing in comprehensive assembly and testing of medical devices. The company provides specialized manufacturing capabilities within controlled environments, ensuring quality and regulatory compliance for critical applications in the medical sector.

Kalamazoo, MI

Based in Kalamazoo, MI, Sterling Industries is a medical device contract manufacturer. They offer end-to-end development, manufacturing, and Class 7 cleanroom assembly services for medical devices and components. The company ensures consistent quality and regulatory compliance, managing everything from design to final packaging for its clients.

Rochester, NY

Syntec Optics, based in Rochester, NY, offers certified clean room assembly services. They specialize in precision electro-optical, opto-mechanical assembly, and photonics packaging. Their expertise covers products from simple lenses to complex integrated circuit boards and actuated tunable lenses, catering to B2B clients.

Franklin, OH

Based in Franklin, OH, Tech-Way Industries provides expert cleanroom production services. The company specializes in manufacturing components crucial for medical device companies, adhering to strict standards for critical applications within a controlled environment.

Claremont, CA

Based in Claremont, CA, Therapak provides comprehensive cleanroom kitting solutions for the drug development, medical device, and diagnostic industries. Their ISO 5 certified cleanrooms adhere to ISO 14644 standards, ensuring sterile and efficient assembly for various healthcare products. Therapak is part of Resonant Clinical Solutions.

Springboro, OH

Western Environmental, a division of Controlled Environment Systems, specializes in designing and constructing custom cleanrooms, metrology labs, and CMM enclosures. They offer turnkey design and build solutions for precise environmental control. Services include cleanroom construction for aerospace, pharmaceutical, medical, and technological industries, plus testing and maintenance.

WHK BioSystems offers contract device manufacturing and assembly in Class 7, ISO 13485 certified, FDA registered cleanroom facilities. They specialize in single-use process components, custom tube kits, and medical device overmolding for biopharma, life science, and cell therapy industries.

Woodstock, IL

Woodstock Sterile Solutions provides aseptic manufacturing for sterile solutions and complex liquid projects. They utilize blow-fill-seal technology for container forming, filling, and sealing. Offering development to commercial production, they serve ophthalmic and respiratory applications within controlled cleanroom environments.

San Jose, CA

Based in San Jose, CA, Applied Engineering, Inc. is a high-tech contract manufacturer specializing in precision electromechanical manufacturing solutions. They offer turnkey and custom manufacturing, including complex sub-assemblies and integrated capital equipment, with cleanroom assembly in Class 10,000 to Class 1,000 environments. Services support clean energy, medical devices, and semiconductor industries.

Flowery Branch, GA

As a contract manufacturer, GRI-USA provides clean room manufacturing and conversion services for a variety of components and finished products. They offer customized product solutions for the Healthcare and Industrial markets, focusing on strategic partnerships.

Brookfield, CT

HQ Pack specializes in designing, manufacturing, and servicing tailored packaging solutions for sensitive technologies. Utilizing in-house cleanrooms and manufacturing facilities, they ensure valuable parts arrive in pristine condition. The company provides an all-encompassing solution, supporting sustainability goals through circularity in packaging and offering cleaning and storage services.

Hayward, CA

Ultra Clean Holdings Inc. specializes in designing, manufacturing, and assembling critical subsystems for the semiconductor and advanced technology markets. Based in Hayward, CA, their comprehensive services include ultra-high-purity component cleaning, precision machining, welding, and advanced cleanroom assembly and integration, serving B2B customers.

Fremont, CA

Based in Fremont, CA, A&D Precision Inc. is a contract manufacturer offering clean room assembly services in Class 1,000 and 10,000 environments. They specialize in assembling equipment for the medical, life science, and semiconductor industries, providing comprehensive services including precision machining and design assistance.

Based in the USA, AES Clean Technology designs, manufactures, and installs cGMP modular cleanrooms. The company provides expertise to secure the success of new cleanroom builds or upgrades for various industries, establishing itself as a standard in cleanroom solutions.

Carlsbad, CA

Argonaut Manufacturing Services provides contract manufacturing solutions for life sciences and IVD companies. They specialize in aseptic and non-aseptic drug fill-finish, lyophilization services, and drug-device combination product manufacturing. The company also offers comprehensive analytical and quality control support for pharmaceutical products.

Indianapolis, IN

Astropak provides precision assembly services, utilizing state-of-the-art facilities and expertly trained technicians. The company ensures that components are assembled with a high degree of precision and cleanliness, meeting stringent requirements for various industrial applications. They focus on delivering meticulously crafted assemblies for their clientele.

Based in Sterling, MA, BMP Medical offers custom medical plastics manufacturing and assembly services for OEMs. Specializing in injection molding and precision medical manufacturing, the company provides cleanroom assembly for medical and diagnostic components. With over 45 years of experience, they support product development and scale-up.

Plexus is a general contractor providing design-build, pre-construction, and self-perform trade work. The company specializes in delivering projects for various sectors, including Life Sciences and Healthcare, where specialized facilities like cleanrooms are often constructed. They offer technical expertise, preconstruction know-how, and project management to meet client objectives.

Tampa, FL

Based in Tampa, FL, Cleanroom Design LLC specializes in comprehensive cleanroom solutions. The company provides expert consultation, design, engineering, and the construction of turnkey cleanroom installations. They offer build and certification services for various industries that require precisely controlled environments.

Gilroy, CA

Flowstar Corporation, based in Gilroy, CA, manufactures and supplies high-performance cleanroom equipment and solutions. The company offers custom-built, turn-key, portable, and modular cleanrooms, including softwall and hardwall designs. They also provide HEPA filter workstations and laminar flow modules from their 23,000-square-foot facility.

Forum Contract Manufacturing provides ISO Class 7 cleanroom assembly and molding services, capable of producing 100,000-200,000 parts monthly. With over 30 years of experience, the company specializes in injection molding, including micro, insert, and over molding for the medical industry, plus prototyping and printing.

Grand Rapids, MI

Based in Grand Rapids, MI, Grand River Aseptic Manufacturing (GRAM) is a contract development and manufacturing organization (CDMO). They specialize in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges, serving pharmaceutical and biotechnology partners.

Keller Technology Corporation specializes in designing and building electromechanical assemblies, equipment, instruments, and turnkey systems. They provide build-to-print services within controlled environments, demonstrating capabilities for high-precision cleanroom assembly. The company serves industrial and commercial B2B clients requiring sophisticated custom solutions.

Chantilly, VA

MFG One is a US-based electronic contract manufacturer offering cleanroom assembly services. They specialize in catheter drilling, precision tube cutting, RF welding, and box-build assembly. Supporting design to fulfillment, MFG One serves medical devices, biotechnology, and electronics industries.

South Windham, CT

Based in South Windham, CT, Micro Precision Group specializes in precision machining and assembling critical components. Serving demanding industries like the US Navy and nuclear sectors, they ensure no room for error under rigorous conditions. The company is ISO 9001:2015 certified, holding NAVSEA approval for high-standard assemblies.

Salem, NH

Micro-Precision Technologies (MPT), based in Salem, NH, specializes in cleanroom assembly for high-temperature electronics and power semiconductors. The company provides hybrid assembly, die attachment, wire bonding, and semiconductor packaging services. MPT operates a Class 10,000 Cleanroom, offering contract manufacturing for both prototype and production volumes.

Millar, Inc. delivers customized OEM solutions, specializing in sensor technology for medical devices and industrial applications. The company operates an ISO Class 7 Clean Room to ensure high manufacturing precision and cleanliness. They support OEM customers with expert cleanroom assembly capabilities, bringing visions to life.

Ascential Medical & Life Sciences specializes in cleanroom manufacturing for sterile, compliant medical products, serving the life sciences and medical device industries. They offer comprehensive services from product development and prototyping to scaled production. This includes advanced manufacturing, complex automation integration, and ensuring quality compliance for all product phases.

Primo Medical Group provides comprehensive medical device development, manufacturing, and assembly services. The company offers ISO Class 7 cleanroom assembly and packaging for quality medical devices, supporting products from concept to commercialization. They produce devices for diagnostics, treatment, and patient care across multiple specialties.

Longmont, CO

PTA Plastics is an employee-owned custom plastic injection molder specializing in high-precision components. They operate certified cleanrooms with advanced technology, ensuring products meet exact specifications. Offering comprehensive DFM, in-house moldmaking, and value-added services, PTA Plastics delivers high-quality plastic parts for diverse industrial applications.

Danbury, CT

Based in Danbury, CT, RK Manufacturing operates a 15,000 square foot ISO Class 8 (100,000) clean room. The company provides cleanroom assembly services utilizing state-of-the-art environmental controls and is certified to ISO 14644-1, ensuring high-quality, controlled manufacturing environments for various clients.

Sur-Seal provides custom manufacturing for engineered components and materials, utilizing clean rooms for services including die cutting, CNC cutting, lamination, and assembly. The company manufactures precise die-cut, molded, formed, and extruded products, holding AS9100 and ISO9001 certifications.

Tualatin, OR

TEK Centers of Excellence is a contract manufacturing company specializing in cleanroom assembly services. They operate an in-house certified ISO Class 7 Clean Room, performing sterile hose assemblies, manifolds, packaging, and inspections for various applications.

Shelbyville, IN

Based in Shelbyville, IN, Thunderbird Molding specializes in custom plastic injection molding and contract manufacturing. They provide comprehensive services including mold design, prototyping, engineering, and production. Their facility includes a clean room approved for assembly, ideal for high-precision medical parts production.

Indianapolis, IN

Based in Indianapolis, IN, Paragon Medical specializes in cleanroom assembly and packaging services for the medical industry. The company provides precision metal components with assembly in a Class 8, ISO 100000-certified clean room, offering comprehensive manufacturing solutions for medical device development and production.

Patheon specializes in providing flexible sterile fill-finish services across its global facilities. They accommodate a variety of molecules and parenteral dosage formats, crucial for pharmaceutical and biologic products. These operations inherently involve cleanroom environments for the precise and sterile assembly and packaging of sensitive materials.

Porta-King manufactures modular and preassembled building systems, including cleanrooms and controlled environmental rooms, since 1969. They provide contamination-free environments essential for sensitive manufacturing, scientific research, and laboratory work. Their adaptable structures ensure peak performance and output for industries requiring precise environmental control.

Viant Medical specializes in comprehensive medical device manufacturing, encompassing design, development, fabrication, and assembly. The company produces reliable and efficient interventional and inhalation devices to cater to diverse healthcare requirements. With robust manufacturing capabilities, Viant Medical supports the MedTech industry.

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How to Choose a Company

  • Mandate a clear ISO 14644 cleanroom classification and review their particulate monitoring data. Don't just accept 'Class 7'; verify they regularly monitor and report against the specific airborne particulate count limits for your application, especially for critical zones like laminar flow benches where unidirectional airflow is crucial.
  • **Scrutinize their Process Validation capabilities (IQ, OQ, PQ) and demand evidence of a robust Validation Master Plan (VMP).** For medical device or pharmaceutical applications governed by ISO 13485 or cGMP, a supplier merely having a cleanroom is insufficient; they must demonstrate a documented, auditable process for installation, operational, and performance qualification of all assembly equipment and processes.
  • **Verify their bioburden control protocols, especially for sterile or aseptic products.** Ask about their environmental monitoring program, sanitization agents, and how they manage microbiological growth. An ISO Class 7 cleanroom without stringent bioburden controls is inadequate for an implantable device.
  • **Assess their gowning protocol and material compatibility within the cleanroom.** Ensure their cleanroom garments, tooling materials, and cleaning agents are non-shedding and won't introduce contaminants or react negatively with your product components—a common oversight that can lead to unexpected contamination.
  • **For electro-sensitive assemblies, confirm their integrated ESD protection strategy.** This goes beyond grounding wrist straps; inquire about ionizers, conductive flooring, cleanroom-compatible ESD-safe tooling, and their documented ESD control plan within the controlled environment, potentially requiring adherence to standards like ANSI/ESD S20.20.

Frequently Asked Questions

What's the real difference between an ISO Class 7 and an ISO Class 8 cleanroom for my product?

The primary difference lies in the allowable airborne particulate count per cubic meter at specified particle sizes. An ISO Class 7 permits significantly fewer particles (e.g., 352,000 particles ≥0.5 µm) compared to an ISO Class 8 (3,520,000 particles ≥0.5 µm). For buyers, this translates directly to the level of contamination risk. Delicate microelectronics or non-sterile medical devices might be suitable for Class 8, whereas more sensitive medical components or ophthalmic products often necessitate Class 7 or higher due to their lower tolerance for contamination and bioburden.

Beyond the cleanroom itself, what 'hidden costs' should I budget for with a cleanroom assembly supplier?

Many first-time buyers focus solely on the cleanroom's hourly rate but overlook substantial ancillary costs. The biggest 'hidden' expenses often stem from Process Validation (IQ, OQ, PQ) requirements, especially for FDA-regulated products. This can involve significant engineering hours, documentation, and specific testing. Other costs include specialized gowning protocol supplies, environmental monitoring fees, specialized packaging materials compatible with the cleanroom, and dedicated tooling or fixtures designed to be non-shedding and cleanroom-friendly.

How do I ensure a cleanroom assembly supplier's *ESD protection* protocols are sufficient for my sensitive electronics?

Don't rely just on verbal assurance. Request their documented ESD control plan, which should detail grounding procedures, static dissipative surfaces, ionization equipment deployment, and employee training. Crucially, ask about their cleanroom-compatible ESD-safe tooling and how often they audit their ESD controls within the clean environment. Some suppliers might have excellent cleanrooms but a weaker understanding of integrated ESD management.

What role does environmental monitoring play, and what should I expect from a supplier?

Environmental monitoring is critical for continuous verification of cleanroom performance. A robust supplier will have a detailed program covering airborne particulate count, temperature, humidity, and microbiological monitoring (for bioburden control). You should expect regular reporting on these metrics, evidence of alarm protocols for excursions, and corrective actions taken. This monitoring data is crucial for demonstrating ongoing compliance and product integrity, especially for ISO 13485 or cGMP environments where audit trails are paramount.

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