ACH Engineering delivers turnkey cleanroom design and installation services across Texas, USA. They specialize in GMP modular cleanrooms, HVAC, and lab furniture, meeting ISO, GMP, and FDA standards. Serving biotech, aerospace, semiconductors, EV battery, and data center industries, they ensure controlled environments for critical operations.
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Cleanroom Manufacturing Companies
Last updated: January 2026
This directory lists 96 cleanroom manufacturing companies across the United States, from specialized regional providers to large-scale national operations.
Buyers are primarily solving for stringent contamination control, aseptic manufacturing, or critical component assembly in controlled environments. This often involves mitigating risks associated with particulate shedding, microbial ingress, and cross-contamination, particularly for sensitive products like sterile medical devices, biologics, or microelectronics. Ensuring compliance with cGMP regulations and maintaining precise environmental parameters such as temperature, humidity, and differential pressure are common challenges.
The cleanroom manufacturing landscape includes contract manufacturers specializing in specific ISO classifications (e.g., ISO Class 7 for device assembly, ISO Class 5 for sterile filling), dedicated aseptic processing facilities, and those focused on precision cleaning or ultra-high purity component handling. Some offer vertically integrated services from mold making to sterile packaging, while others excel in discrete cleanroom operations, often distinguished by their primary market such as medical, pharmaceutical, aerospace, or semiconductor industries.
Buyers should arrive prepared with detailed specifications including required ISO 14644 cleanroom class, specific process flow diagrams indicating critical zones, desired bioburden limits, and any unique environmental monitoring parameters. Suppliers, in turn, expect a clear understanding of the product's intended use, regulatory pathway (e.g., FDA Class II, IVD), and anticipated production volumes to properly assess facility fit, resource allocation, and ensure compliance with relevant industry standards.
Company Directory
96 companies nationwide
Allied Cleanrooms manufactures and installs modular hard wall cleanrooms and environmental enclosures. With facilities in California, Texas, and Tennessee, the company offers custom, turnkey cleanroom solutions nationwide. They design and build cleanrooms to client specifications, ensuring no on-site construction mess.
Based in Webster, TX, Allometrics Inc. specializes in comprehensive cleanroom and lab solutions. They offer cleanroom design, construction, and cleaning services, along with customized solutions. Additionally, the company provides calibration and certification services, and equipment/supply sales for diverse cleanroom needs across the United States.
American Cleanroom Systems, based in Rancho Santa Margarita, CA, specializes in the design, manufacturing, and installation of modular and softwall cleanroom systems since 1976. They provide ISO5-ISO8 and Class 100-100k cleanrooms with environmental controls for pharmaceutical, medical device, and industrial clients, proudly made in the USA.
AMS provides contract manufacturing, specializing in ISO clean room production. Capabilities include injection molding, assembly, die casting, roto molding, and extrusions. They offer rapid prototyping, rapid bridge tooling, plus comprehensive warehousing and fulfillment. AMS manages the entire supply chain from manufacturing to delivery.
Advanced Technology Group Inc. provides cleanroom construction services for Class 1 to 10,000 environments. They build cGMP compliant spaces for clients in the microelectronics, semiconductor, pharmaceutical, biotechnology, healthcare, and telecommunications industries, leveraging proprietary processes and 30 years of experience.
AVM Group specializes in the design, engineering, and construction of turnkey cleanrooms and controlled environments. Their proprietary MatterGuard hardwall cleanrooms utilize HEPA filters and advanced airflow systems to precisely regulate particulates. AVM serves diverse industries, including pharmaceuticals, biotechnology, semiconductor, and medical device manufacturing.
NovoSci, located in Conroe, TX, is a medical device contract manufacturer specializing in single-use, sterile products. They provide Class 7 cleanroom manufacturing and assembly, utilizing methods like ultrasonic welding and adhesive bonding. The company is ISO 13485:2016 certified and FDA registered, serving cardiovascular and general surgery markets.
Based in The Woodlands, TX, Cellipont Bioservices is a Contract Development and Manufacturing Organization (CDMO). They offer cGMP-compliant cleanroom manufacturing services for advanced cell therapies, including bioreactor technology. The company supports large-scale commercial production for biopharmaceutical clients.
Based in Rancho Santa Margarita, CA, Class One Cleanroom Systems, Inc. manufactures prefabricated modular cleanrooms and related components. They produce wall systems, fan filter units, HEPA filters, and LED lighting. Services include design, construction, installation, testing, and certification, ensuring projects meet ISO requirements with over 40 years of experience.
Based in Canton, MI, Clean Air Technology specializes in the turnkey design, engineering, fabrication, installation, and testing of ISO Class 1 to Class 9 modular cleanrooms, dryrooms, and custom HVAC equipment. They serve pharmaceutical, aerospace, medical, defense, and electronics industries.
Clean Room Depot, based in Holbrook, NY, designs, constructs, and manufactures custom modular hardwall and softwall cleanrooms. With 35 years of experience, they offer single-source contamination control solutions, including enclosures, laminar flow products, and a range of accessories, alongside engineering and construction services.
Based in Placentia, CA, Cleanroom Film & Bags (CFB) manufactures custom cleanroom bags and sterile packaging solutions. The company operates ISO 9001:2015 certified cleanrooms, serving critical industries such as medical, electronic, aerospace, semiconductor, and food products.
Based in Chino, CA, Cleanroom Logic specializes in designing, building, and installing modular and structural cleanrooms. They provide custom and standard cleanroom solutions for pharmaceutical, semiconductor, food processing, manufacturing, medical, and research and development industries.
Based in Corona, CA, Cleanrooms By United specializes in the custom design, manufacturing, and installation of modular and prefab cleanrooms. They offer ISO classes 5-8 cleanroom manufacturing capabilities, ensuring direct compliance with ISO 14644-1 standards. Services are available nationwide.
Based in Costa Mesa, CA, Cleanroom Solutions provides mobile cleanrooms for the medical device manufacturing industry. They offer fully contained, ISO 5-8 certified semi-trailers, ideal for aseptic environments and temporary needs. These turnkey solutions support Class 1-3 medical devices, including full temperature and humidity control for quick deployment.
Based in Brownsburg, IN, Cleanrooms USA designs, constructs, and installs cleanroom facilities. They manufacture GRP and HPL partition systems, accessories, and offer turnkey modular cleanroom solutions. Services support industries like biologics, drug manufacturing, medical devices, semiconductors, and EV battery production.
Swagelok Cleveland provides ISO-certified cleanroom fabrication services, specializing in high-purity component assembly and custom fluid systems. Based in Solon, OH, this facility offers precise manufacturing solutions for demanding industrial applications, ensuring controlled environments for sensitive component production and assembly needs.
Based in San Diego, CA, Coastline International, Inc. provides cleanroom manufacturing services. The company operates multiple Class 8 clean rooms, encompassing over 9,000 square feet of dedicated space, specializing in medical equipment manufacturing and other precision applications for commercial clients.
Based in Menlo Park, CA, Control Plastics Inc. specializes in cleanroom manufacturing services, providing Class 8 injection molding and Class 7 assembly exclusively for medical parts and devices. They maintain stringent environmental controls, monitoring pressure, temperature, humidity, and particle counts daily. The company adheres to ISO 14644 cleanroom regulations.
Cortec Precision Manufacturing offers comprehensive fabrication services, including laser cutting, punching, forming, machining, welding, and assembly. The company operates cleanroom facilities equipped with CDA and N2 purge systems for sensitive packaging, along with electrical, mechanical, and electromechanical assembly capabilities across a 20,000 sq. ft. space.
Cypress Industries operates a Class 100K clean room to support contract manufacturing and value-added services for clients. It enables the packaging of materials in a controlled environment, preventing contamination before products enter other sensitive manufacturing cleanrooms. This ensures high-quality and integrity for manufactured components.
Based in Tipp City, OH, Danco Medical Systems designs and builds custom cleanrooms for medical and manufacturing industries. They offer modular solutions or outfit existing spaces to meet ISO-01 to ISO-8 and USP 797/800 compliance, including customized layouts and HEPA filter installation.
DesignPlex Biomedical LLC, based in Fort Worth, TX, is a contract manufacturer providing cleanroom and GMP manufacturing services. The company offers prototyping, design, and development from its state-of-the-art facilities. Committed to quality, they ensure pristine conditions for biomedical product production.
Based in Fort Collins, CO, Eldon James Corporation operates a 42,000 square foot, ISO Class 7 cleanroom. They specialize in manufacturing PVC-free tubing and fittings for life sciences, bioprocess, biomedical, and pharmaceutical applications. Products are double-bagged and sealed within the clean environment, ensuring readiness for critical-use applications.
Based in Orange, CA, Ezad Cleanrooms manufactures modular hardwall and softwall cleanrooms. They fabricate robust, free-standing units offering custom dimensions and various wall materials. Serving the semiconductor, medical device, pathology, and pharmaceutical research fields, Ezad Cleanrooms provides solutions compliant with ISO Class 5 through ISO Class 8 standards.
Filtration Technology Inc., based in Greensboro, NC, specializes in providing cleanroom environments for critical applications like medical device manufacturing. Services include cleanroom design, installation, certification, and support for ISO Class 7 and USP 797 compliance. They have been delivering controlled environments since 1971.
Based in College Station, TX, G-CON Manufacturing, Inc. provides innovative cleanroom manufacturing solutions. The company specializes in prefabricated cleanrooms designed to accelerate pharmaceutical and biotech facility development, offering efficient and high-quality environments for critical manufacturing processes.
Germfree is a company specializing in the design and manufacturing of mobile and modular cleanrooms, laboratories, and equipment. They provide turnkey aseptic processing and containment solutions for the pharmaceutical, healthcare, and biocontainment industries. Germfree offers end-to-end services including engineering, project management, and facility installation.
Based in Buena Park, CA, Hi-Tech Medical Products specializes in cleanroom converting and precision die-cutting of medical-grade materials. They perform manufacturing services for medical applications within certified cleanrooms, adhering to ISO 13485:2016 standards. As a 3M / Solventum Premier Converter, they leverage certified expertise.
Based in Rollinsford, NH, Janco Medical is an ISO 13485 certified, FDA registered contract manufacturer. They specialize in thermoforming and compression-molded services for medical and industrial markets. The company utilizes ISO 14644-1 Class 7 and Class 8 certified cleanrooms to produce secure, sterile medical packaging.
KS Group provides specialized contract manufacturing services, including plastic injection molding and cleanroom and white room assembly. They offer ultrasonic cleaning, UV bonding, and support from prototyping to finished goods. Based in San Leandro, CA, they serve highly regulated industries with expertise in product development and manufacturing.
Based in Salt Lake City, UT, Labs USA provides modular cleanroom systems, including HardWall, SoftWall, and RidgidWall constructions. Their durable cleanrooms meet ISO Class 8 to Class 5 requirements, featuring Class A fire-rated panels, tempered safety glass, and customizable airflow for various industrial applications.
Based in Saint Charles, MO, Logic Material Handling designs and installs pre-engineered ISO cleanrooms and quality control rooms. The company provides nationwide services, focusing on rapid and clean installation with an in-house project management and installation team for controlled environments.
Based in Lake Forest, CA, M4D LLC provides cleanroom manufacturing services, specializing in medical device design, development, and integration. They operate three dedicated ISO Class 8 cleanrooms totaling 12,000 sq. ft, supported by a robust quality system for GMP practices and California Department of Public Health certification.
Based in Stoughton, MA, Marver Med provides precision machining and cleanroom assembly services specifically for medical device manufacturing. The company maintains controlled environments to prevent contamination, ensuring patient safety and product efficacy. They adhere to strict regulatory standards including FDA QSR and ISO 13485:2016, delivering high-quality medical solutions.
Based in San Antonio, TX, Mentco, Inc. specializes in ultra-pure CNC machining and precision manufacturing, utilizing its in-house Class 100 cleanroom. They serve sensitive industries like semiconductor manufacturing, pharmaceuticals, and biotechnology, ensuring a pristine, particle-free environment for high-purity production needs.
Based in Somerset, NJ, MICRO is a full-service contract manufacturer specializing in precision medical devices, subassemblies, and components. The company maintains five ISO Class 8 and Class 9 cleanrooms, staffed by highly trained technicians. They produce a variety of minimally invasive surgical instruments, including scissors and biopsy devices.
Based in Denver, CO, Modular Cleanrooms, Inc. specializes in comprehensive hardwall and softwall modular cleanroom solutions. The company offers custom designs, essential components, filters, furniture, and supplies for various cleanroom applications, guiding projects from concept to realization.
Based in San Carlos, CA, Modulus Cleanrooms provides modular cleanrooms, offering both hardwall and softwall options. The company designs and supplies cleanroom solutions to suit various industries, ensuring tailored environments for specific manufacturing needs.
Based in Santa Barbara, CA, the UC Santa Barbara Nanofabrication Facility offers 12,000 sqft. of Class 100 and 1000 cleanroom space. It provides state-of-the-art equipment and expert staff for nanofabrication, process support, and hands-on fabrication services. The facility assists researchers and industry with industrial prototyping and advanced R&D.
Based in Knoxville, TN, National Partitions provides customizable modular cleanrooms, such as a 12x20x10-high unit. These cleanroom solutions are designed to meet strict industry standards for sensitive manufacturing operations, directly supporting companies requiring controlled environments.
Based in Norwood, NJ, Nicos Group, Inc. designs, supplies, and installs modular cleanrooms for various manufacturing and assembly areas. They provide turnkey cleanroom installation services, serving industries like pharma, life science, medical device, automotive, semiconductor, and biotech.
Based in Roanoke, VA, P1 Technologies is a contract manufacturer with over 75 years of U.S.-based experience. They offer vertically integrated capabilities including cleanroom and sterile barrier packaging, precision molding, and custom cable assemblies for medical, defense, and audio markets.
Based in Taylor, TX, Paradigm Metals specializes in cleanroom assembly within a Class 1000-6 environment, featuring constantly filtered air and multi-sensor particle monitoring. Their cleanroom operations are regularly audited by FDA and ISO registrars. The company also provides precision sheet metal, CNC machining, laser cutting, and powder coating services.
PEKO Precision offers ISO 6 (Class 1000) cleanroom assembly services, providing 12,000 square feet of certified space for clean-critical applications. They specialize in assembling functional mechanical, electromechanical, and optical systems for OEMs. Services include contract manufacturing, NPI, and prototyping for medical, semiconductor, and aerospace industries.
Based in Carpinteria, CA, NuSil Technology provides cleanroom contract manufacturing services. The company specializes in silicone compounding, with its facility opened in 2010. They process Active Pharmaceutical Ingredients (API) into silicones, serving pharmaceutical technology needs.
Based in Zeeland, MI, Plascore, Inc. specializes in modular cleanroom systems with over 40 years of experience. They provide solutions for the pharmaceutical and semiconductor industries. Their modular wall systems are designed to reduce onsite construction costs and installation time for various project sizes.
Based in Chesterfield, MO, PortaFab Corporation is a modular cleanroom manufacturer with over 40 years of experience. The company specializes in designing, engineering, and manufacturing custom cleanroom systems for various industrial applications.
Based in Santa Ana, CA, Precision Converting offers ISO Class 7 (Class 10,000) cleanroom manufacturing services. They specialize in custom cleanroom die-cutting, slitting, laminating, and assembly for demanding controlled environments. Serving industries such as medical, electronics, and aerospace, they provide precision converting solutions.
Based in Brenham, TX, Precision Polymer Engineering operates multiple clean rooms for manufacturing high-performance elastomer components. The company specializes in fully molded O-rings, wafer handling components, slit valve doors, and custom seals. These products serve critical sealing applications primarily within the semiconductor and food/dairy industries.
Based in Stoughton, MA, Primo Medical Group offers ISO 13485:2016 certified cleanroom manufacturing services. Their 30,000 sq ft ISO Class 7 facilities specialize in precision assembly, testing, and packaging of various medical devices. They handle medical implants, instruments, surgical tools, and electro-mechanical devices under strictly controlled conditions.
Pro-Tech Design & Manufacturing provides medical device contract manufacturing, packaging, and assembly services. Their FDA and ISO 13485 registered facilities feature Class 10,000/ISO 7-rated cleanroom spaces, ensuring controlled environments for critical production. They offer end-to-end solutions from multiple US locations.
Based in Yorba Linda, CA, SpecialTeam is an FDA registered and ISO 13485:2016 certified full-service Medical Device Contract Manufacturer. The company provides comprehensive cleanroom manufacturing services for medical devices, ensuring compliance and quality.
Starrco, based in Maryland Heights, MO, designs, engineers, and manufactures modular cleanroom systems. They provide fast, affordable, and customizable cleanroom solutions, crafting modules at their facility for quick on-site assembly. Their versatile systems offer rapid installation, adapting to evolving needs for critical cleanliness applications.
Based in Cedar Park, TX, Texas Technologies provides contract manufacturing and cleanroom packaging services for critical environments. They also supply cleanroom consumables, apparel, corrosion control, and ESD products. The company offers specialized packaging, sealing equipment, and moisture barrier solutions for diverse industries.
Based in Carlsbad, CA, Total Source Manufacturing operates as a contract manufacturer. The company specializes in producing cleanroom supplies and personal protective equipment (PPE), providing essential manufactured goods for industries that require stringent quality and environmental controls in their operational environments.
UFP Technologies, Inc., based in Newburyport, MA, provides cleanroom foam fabrication and packaging solutions. Their ISO Class 7 and 8 certified facility in El Paso, TX, offers intricate die-cutting, machining, and assembly services for medical, electronic, automotive, and optical device manufacturers, processing medical-grade foams.
NGS Cleanrooms US designs, develops, and installs modular cleanroom systems. They provide high-quality modular wall cleanrooms, tailored to specific client requirements, ensuring exacting standards. Their cleanrooms are designed for stringent operation and can be validated to EU and ISO standards.
Based in Trevor, WI, Vonco Products, LLC is an ISO 13485 certified contract manufacturer. They specialize in medical device cleanroom manufacturing, offering RF welding, heat sealing, assembly, and packaging within Class 7 cleanrooms for plastic products, including fluid bags and Class I, II, and III medical devices.
Based in Springboro, OH, Western Environmental specializes in the construction of cleanrooms, metrology labs, and other environmentally controlled enclosures. The company serves diverse industries, including aerospace and medical, leveraging over two decades of experience in technically complex projects.
WHK BioSystems provides custom device manufacturing and assembly services within Class 7 cleanroom facilities. The company is ISO 13485 certified and FDA registered, specializing in biopharmaceutical, life-science, and medical applications. Their capabilities include injection molding, RF welding, and medical tubing extrusion.
Based in Attleboro, MA, Unified Cleanroom Constructors specializes in complete cleanroom and dryroom envelope assembly and installation services. They offer turnkey modular cleanroom solutions, room modifications, preventive maintenance programs, and certification services. The company supports critical environments for pharmaceutical and semiconductor industries, ensuring compliance with ISO 14644 standards.
Performance Contracting, Inc. provides design assist construction services, specializing in custom cleanroom solutions. They partner with clients in the life science and microelectronic industries to deliver high-performance, controlled manufacturing environments tailored to specific operational requirements.
GRI-USA provides contract cleanroom manufacturing and conversion for various components and finished products. Specializing in FDA Class I and Class II medical devices, they offer extensive capabilities like film extrusion, injection molding, thermoforming, ETO sterilization, and sterile packaging. The company operates Class 100K cleanrooms.
Based in Attleboro, Hodess Cleanrooms designs, engineers, constructs, and supports Clean, Dry, and Environmental Rooms. They provide full lifecycle services from development and construction to operations and retrofits. The company serves diverse sectors including biotechnology, medical device, pharmaceutical, and semiconductor industries.
Based in Santa Clara, CA, Lumenous offers high-volume microforming, subassemblies, and final assembly services. They provide cleanroom manufacturing capabilities up to Class 10K or 100K, utilizing laminar flow hoods. The company specializes in laser processing, surface treatment, and contract manufacturing for precision components and devices.
Molded Devices, Inc. offers comprehensive cleanroom manufacturing and assembly services, adhering to ISO 13485 standards for medical device companies. They provide ISO 1-9 classified environments for processes including molding, extrusion, bonding, and sterile packaging. MDI specializes in producing medical balloons, catheters, cannulas, and various single-use medical devices.
Based in Okarche, OK, Nortek Air Solutions designs and fabricates modular, self-supporting cleanroom systems. They offer freestanding hardwall or softwall solutions in custom sizes, shapes, and materials, including individual workstations. Their cleanrooms meet various cleanliness levels, from ISO 4 to 9 and USP 797/800.
Based in Addison, TX, Precision BioMEMS operates an ISO Class 5 cleanroom facility for Micro-Electrical Mechanical Systems (MEMS) fabrication. They offer comprehensive foundry services to third-party companies, specializing in biocompatible microelectrode arrays and advanced micro mechanical sensing using photolithography, PECVD films, and polymer processing.
Based in Richmond, TX, Velentium Medical offers USA-based medical contract manufacturing for Class II and III devices like implantables and catheters. Their FDA Registered, ISO 13485 Certified, and cGMP Compliant facility provides prototype to commercial production, including sterile packaging, advanced testing, and various molding and welding processes.
Based in Fremont, CA, A&D Precision Inc. maintains multiple certified Class 1,000 and 10,000 clean rooms, providing over 6,000 sq ft for molding and assembly. They serve biomedical and other industries requiring stringent cleanliness, performing sonic welding, heat sealing, inspection, and final packaging.
Based in the USA, AES Clean Technology specializes in the design, manufacture, and installation of cGMP modular cleanrooms. The company offers comprehensive expertise for clients seeking to build or upgrade controlled environments. AES ensures secure and successful cleanroom operations for various industries requiring high-standard cleanroom infrastructure.
Based in Sterling, MA, BMP Medical provides ISO Class 8 cleanroom manufacturing services, specializing in plastic injection molding and assembly. They offer IVD contract manufacturing for point-of-care, molecular, and lab-based devices, producing custom-molded housings and sample prep components. The company supports diagnostic OEMs.
Based in Walnut, CA, Clarion Construction, Inc. specializes in the design and construction of custom clean rooms. They provide critical infrastructure for the pharmaceutical, biotech, and food industries, offering tailored solutions for controlled environments in Southern California.
Based in Grand Rapids, MI, MayAir Inc. specializes in designing, engineering, and manufacturing high-performance clean rooms. The company provides tailored solutions to meet stringent contamination control requirements for various industries, ensuring controlled environments for critical operations.
Based in Minneapolis, MN, Clean Air Products manufactures modular, softwall, and hardwall cleanrooms, plus a range of cleanroom equipment. They provide customizable, ISO-compliant controlled environments for demanding sectors. The company offers design, maintenance, and in-house replacement parts, serving life sciences, electronics, and optics industries.
Based in Tustin, Clean Rooms West, Inc. provides comprehensive cleanroom design, engineering, and construction services. The company offers a single-source solution for cleanroom development projects, overseeing implementation from concept to completion. They help organizations successfully manage projects on time and within budget.
CleanSpace Modular LLC, based in Doylestown, PA, designs and builds precision-engineered cleanrooms, cold rooms, and dry rooms. Their CleanFit process offers guaranteed costs and timelines, serving pharmaceutical, biotech, aerospace, electronics, and medical device manufacturing industries.
Based in Jackson, NJ, CleanZones, LLC manufactures and installs modular hardwall cleanrooms. They offer pre-designed, engineered systems for various applications, including electronic assembly and pharmaceutical use. Their cleanrooms effectively control air flow, pressure, temperature, humidity, and filtration, creating a contaminant-free environment.
Forum Contract Manufacturing is an FDA-registered company offering a full suite of assembly services in an ISO Class 7 cleanroom. They provide mechanical and manual assembly, packaging, serialization, adhesive processes, and tooling development, primarily serving medical device assembly needs.
Based in Hayward, CA, Gel-Pak provides cleanroom manufacturing services for innovative packaging solutions and films. Operating ISO Class 7 and Class 8 cleanroom facilities, the company specializes in contamination-controlled production for sensitive devices. They serve clients in the semiconductor, medical, and photonics industries.
Based in Fremont, CA, Ichor Systems provides contract manufacturing solutions. They offer precision machining, rapid prototyping, and assembly services within an extremely clean environment, including two certified Class 100 cleanrooms. The company serves demanding industries such as semiconductor capital equipment, handling ultra-high purity and exotic materials.
Kimball Electronics is a Contract Manufacturing Organization (CMO) specializing in medical device manufacturing, including Clean Room Assembly. They provide precision plastics injection molding, sterilization, and drug delivery device production. Focused on the medical market, they manufacture in vitro diagnostic test kits and surgical products, operating FDA Registered facilities.
Based in Irving, TX, Lasco Services designs and builds custom, modular, and portable cleanrooms. They specialize in USP <797> compliant cleanrooms and contamination control environments, assisting pharmacies and other facilities in meeting regulatory standards. The company also offers cleanroom audits and consulting services.
Based in Houston, Texas, Millar operates an ISO Class 7 cleanroom at its headquarters, supporting product manufacturing, sensor innovation, and rapid prototyping. The company handles engineering and product development for advanced sensors, collaborating with OEMs. Millar provides domestic customer service and technical support, serving U.S. and Latin American markets.
Ascential Medical & Life Sciences offers comprehensive cleanroom manufacturing services for the medical and life sciences sectors. They provide scalable production, product development, design, and advanced automation solutions. Expertise includes medical devices, implantables, diagnostics, and cell therapy, ensuring high-quality, compliant manufacturing processes.
Precision Environments designs and builds world-class cleanrooms for the manufacturing industry. They specialize in custom facilities, often ISO Class 7 or 8, engineered to withstand harsh industrial environments. These cleanrooms support the production of automotive components, among other applications, featuring modular wall systems and essential controls.
PTA Plastics specializes in cleanroom injection molding and assembly. They operate certified cleanrooms for medical device, pharmaceutical, and high-tech industries, focusing on medium-volume production. The company ensures contaminant-free manufacturing, holding ISO 9001:2015 and ISO 13485:2016 certifications.
Based in El Paso, TX, RexMed Health is a certified contract manufacturer specializing in medical devices. They provide full-scale manufacturing technologies, including ISO Class 7 & 8 cleanroom assembly, extrusion, packaging, and sterilization management. They offer end-to-end solutions from design to distribution for OEMs and healthcare.
Based in Salt Lake City, UT, Subzero Engineering designs, engineers, and manufactures hardwall cleanrooms and enclosures. They provide SIS 797 Hardwall Cleanrooms and AirLock Hardwall systems, suitable for all classes of cleanrooms and process isolation. The company also offers engineering, design, and installation services.
Sur-Seal provides custom manufacturing services within an ISO 8/Class 100,000 certified clean room environment. The company specializes in precision die-cutting, CNC cutting, molding, and extrusion for sensitive components and devices. They serve industries including avionics, medical devices, and electronics, ensuring contaminant-free production.
Based in Livermore, CA, Westec Plastics is an ISO 13485-certified contract manufacturer specializing in medical molding solutions. They offer cleanroom and non-cleanroom manufacturing, including two-shot and DNA-free injection molding. Services extend to in-house tooling and various secondary operations for complex plastic components in Microfluidics and other applications.
Based in San Jose, CA, Evolve Manufacturing specializes in contract manufacturing for complex medical and life sciences devices. Their 75,000 sq ft facility includes ISO 13485-certified Class 7 and Class 8 cleanrooms. They offer comprehensive production services, from prototyping to full-scale manufacturing, supporting critical healthcare and scientific innovations.
Flexan specializes in the cleanroom manufacturing of custom silicone, rubber, and thermoplastic components for medical device applications. Operating Class 7 and 8 cleanrooms across multiple US facilities, the company offers custom molding, extrusion, assembly, and packaging services to meet stringent industry requirements.
Based in Hayward, CA, Innovent Technologies specializes in cleanroom assembly services, adhering to SEMI standards. The company provides comprehensive manufacturing solutions, including testing and packaging, for various industrial projects. They focus on ensuring top quality throughout the entire cleanroom production process.
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How to Choose a Company
- Verify Cleanroom Classification and Monitoring: Demand current cleanroom validation reports (e.g., ISO 14644-1 certification) and detailed environmental monitoring data, including viable and non-viable particulate counts, differential pressure logs, and temperature/humidity records relevant to your specific ISO Class requirements (e.g., ISO Class 7 for medical device assembly).
- Assess Aseptic Processing Capabilities: For sterile products, evaluate their specific aseptic processing expertise, including media fill studies, validation of sterilization methods (e.g., EtO, gamma, e-beam), and their gowning protocols, ensuring alignment with EU GMP Annex 1 or FDA Aseptic Processing Guidelines.
- Examine Quality Management System for Regulatory Alignment: For medical devices, insist on a robust Quality Management System (QMS) certified to ISO 13485 and demonstrate compliance with 21 CFR Part 820. For pharmaceuticals, verify cGMP adherence and evidence of regulatory audits (e.g., FDA inspections) relevant to your product.
- Review Contamination Control Strategy (Red Flag): Scrutinize their contamination control strategy beyond just the cleanroom walls. A red flag is a lack of clear, documented procedures for material ingress/egress, waste disposal, personnel training on particulate generation, and robust preventive maintenance schedules for HEPA filters or airflow systems.
- Evaluate Scalability and Equipment Suitability: Confirm they possess the specialized cleanroom-compatible equipment (e.g., automated assembly, injection molding machines, solvent dispensers) necessary for your process and can scale production within the required cleanroom environment without compromising integrity or increasing risk of cross-contamination.
Frequently Asked Questions
How does the required ISO 14644 cleanroom class impact my product's manufacturing cost and lead time?
A higher (lower numbered) ISO cleanroom class, such as ISO Class 5 for aseptic filling, demands more rigorous environmental controls, increased air changes, specialized gowning, and more frequent environmental monitoring, all of which significantly increase operational costs and can extend lead times for validation and setup compared to, say, an ISO Class 8 general assembly. You must align the class precisely with your product's contamination risk profile and regulatory requirements to avoid over-specifying or under-protecting.
What specific documentation should I request to verify a cleanroom manufacturer's compliance for sterile medical devices?
Beyond their ISO 13485 certification, you must request cleanroom validation reports (IQ/OQ/PQ) demonstrating adherence to ISO 14644 standards, recent environmental monitoring data (particulate and microbial counts), equipment calibration records, documented gowning procedures, training logs for cleanroom personnel, and their internal audit reports specifically addressing 21 CFR Part 820 compliance, including any corrective actions.
What are common red flags when a cleanroom supplier discusses their contamination control strategy?
Be wary if a supplier primarily focuses on their cleanroom's physical infrastructure without detailing their operational contamination control plan. Red flags include vague answers about material transfer protocols, lack of documented gowning and degowning procedures, infrequent environmental monitoring schedules, or an inability to produce trend data for viable and non-viable particle counts within their critical zones, indicating a reactive rather than proactive approach to contamination management.
How do I ensure my specific product's unique bioburden and particulate generation characteristics are accounted for by the cleanroom manufacturer?
You need to provide the manufacturer with data on your product's inherent particulate shedding or potential bioburden, especially if it involves specific materials or processes. The supplier should then demonstrate how their cleanroom design, airflow patterns, cleaning protocols, and environmental monitoring plan are tailored to effectively manage and mitigate your product's specific contamination risks, potentially through specialized filtration, localized HEPA coverage, or adjusted cleaning frequencies for your product's process.