Based in Charlottesville, VA, Afton Scientific provides comprehensive aseptic manufacturing and sterile fill-finish services for pharmaceutical companies. They specialize in ensuring product integrity and sterility for biologics and small molecules through expert aseptic processing, quality assurance, and advanced laboratory testing within FDA-inspected facilities.
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Sterilization Services Companies
Last updated: January 2026
This directory lists 58 sterilization services companies across the United States, from specialized ETO facilities to multi-modality providers offering Gamma, E-beam, and X-ray.
Buyers typically engage these services to achieve a validated Sterility Assurance Level (SAL) for medical devices, pharmaceuticals, or other regulated products, often struggling with material compatibility challenges or the complexities of revalidation for product line extensions. They seek partners who can navigate stringent regulatory submissions, particularly concerning methods like ETO, and provide robust dose mapping data.
Suppliers in this space range from focused, regional ETO chambers ideal for sensitive polymers, to large, international players with vast Gamma Irradiation and E-beam accelerators capable of high-volume processing and rapid turnaround. Some offer comprehensive sterilization validation support, while others focus purely on execution based on client-provided protocols.
Buyers should come prepared with detailed product specifications, material data sheets, desired Sterility Assurance Levels, and any pre-existing bioburden data. Suppliers expect clear understanding of your product family and its specific sterilization requirements, including proposed process parameters and packaging configurations to facilitate accurate quoting and protocol development.
A significant trend is the increasing demand for alternatives to ETO sterilization, driven by environmental concerns and stricter emission regulations, leading to greater investment in E-beam, X-ray, and low-temperature vaporized hydrogen peroxide (VHP) solutions, alongside a critical need for suppliers who can support material science evaluation for these newer modalities.
Company Directory
58 companies nationwide
Andersen Scientific, Inc., based in Morrisville, NC, offers custom small-to-medium volume Ethylene Oxide (EO) contract sterilization services. Supporting start-up and small/medium medical device companies, their ISO 13485 certified and FDA registered facility (Est. No. 1064858) emphasizes quality, customer service, and environmentally friendly practices.
Based in Fort Worth, TX, Anubis SceneClean, Inc. specializes in biohazard and crime scene cleanup. Their certified professionals provide thorough decontamination and disinfection for incidents involving blood, bodily fluids, decomposition, or hazardous substances. They also offer medical waste disposal, meth lab cleanup, and odor abatement services.
BioServ, Inc., based in Prospect, CT, provides comprehensive sterilization services and biomedical waste management for medical and industrial clients. Utilizing state-of-the-art autoclaving facilities, the company specializes in the safe and effective destruction of biohazardous waste, ensuring all regulated medical waste meets federal and state regulations for non-infectious disposal.
Based in San Antonio, TX, BioTechs Crime & Trauma Scene Cleaning provides specialized biohazard, hoarding, and crime/trauma scene cleanup services. The family-owned company also offers mold remediation, serving San Antonio and surrounding areas with discreet, 24/7 emergency response since 2002.
Based in Novato, CA, Blue Line Sterilization Services, LLC is an independent contract EO/EtO sterilization company. They specialize in fast, compliant ethylene oxide (EtO) processing for small loads, serving medical device manufacturers. The company offers responsive and reliable 24/7 sterilization services to expedite product market entry.
Boulder Sterilization, located in Boulder, CO, offers quick-turn ethylene oxide (EO) and chlorine dioxide (CD) sterilization services for medical devices and in-vitro diagnostic products. They provide fast turnaround times, measured in weeks, along with clean room final assembly, packaging, and in-house biological testing capabilities.
Based in Solana Beach, CA, Centerpiece Holdings LLC provides comprehensive Ethylene Oxide (ETO) sterilization services, including cycle development and optimization for high and low volumes, with world-class emissions control. They also offer contract manufacturing, packaging, and sterile product warehousing, serving the medical device supply chain with integrated solutions.
Cretex Medical provides contract manufacturing and engineering services to the medical device and pharmaceutical industries. Based in Elk River, MN, their offerings include assembly, kitting, packaging, and sterilization services. The company serves as a reliable partner throughout the product lifecycle, utilizing robust quality systems and industry certifications.
Based in Temple, TX, Steri-Clean Central Texas offers professional biohazard and trauma scene cleanup services nationwide. They specialize in crime scene, suicide, decomposition, and traffic accident cleanup, along with comprehensive infection control. The company provides thorough environmental sterilization and decontamination solutions for various commercial clients.
Crothall Healthcare provides essential sterile processing services for healthcare facilities, utilizing disciplined protocols to enhance safety and efficiency. With over 30 years of experience, the company focuses on minimizing errors and reducing operational costs within hospital environments.
Based in Paso Robles, CA, Eagle Medical Inc. offers sterilization solutions and contract packaging for medical products. The company specializes in identifying efficient sterilization methodologies and is certified to ISO 13485:2016 for its services.
Based in Lubbock, TX, GermBlast provides high-level disinfection and sterilization services. They utilize a patented multistep program for bacteria and virus removal, including mobile disinfection for hospital equipment, killing 99.999% of microorganisms. GermBlast serves businesses, schools, healthcare, dental care, and offers indoor air quality solutions.
Based in Los Angeles, CA, Germ Control Services offers comprehensive disinfection and sanitation solutions for various environments. They provide specialized services including scabies cleanup, immunodeficiency sanitation, air filtration, odor removal, and rodent dropping cleanup, ensuring germ-free and healthy spaces for their clients.
Harmac Medical Products provides fully integrated packaging and sterilization services for medical devices. They assist customers in ensuring their products are safe, sterile, and ready for market. With facilities in Buffalo, NY, they offer comprehensive solutions for quality medical product delivery.
Based in Ithaca, NY, iFyber, LLC provides customized sterilization validation services for organizations using supercritical carbon dioxide (scCO2) systems. As a preclinical CRO, they offer research expertise, regulatory consulting, and custom method development. Their capabilities also include material characterization and antimicrobial efficacy testing.
Instrumentum offers offsite surgical instrument sterilization services for hospitals, OEMs, and supply chain departments. They manage the complete instrument set lifecycle, from picking up soiled trays to thorough sterilization and timely delivery of vendor loaner trays. This innovative approach optimizes reprocessing and enhances patient safety.
Midwest Sterilization Corporation provides contracted Ethylene Oxide (EO) sterilization services for the medical device industry. With state-of-the-art facilities and over 55,000 cubic feet of sterilization capacity across two U.S. locations, they customize cycles or use validated ones.
Nelson Labs provides comprehensive sterilization validation solutions to ensure product quality and regulatory compliance for various industries. The company specializes in laboratory testing and validation services, helping clients meet stringent requirements for sterile medical devices and other regulated products. They offer expert analysis and support for sterilization processes.
NovaSterilis offers medical device sterilization services, specializing in supercritical CO2 technology. They provide an eco-friendly, cost-effective solution for complex devices, novel biomaterials, and liquid formulations. The company helps achieve Sterility Assurance Level 10-6, preserving material properties and accelerating R&D timelines.
Based in El Cajon, CA, Pacific Sterilizer, Inc. provides comprehensive service and maintenance for sterilizers, autoclaves, medical/lab washing equipment, and other infection-control equipment. With over 30 years of experience, their factory-trained technicians serve operating rooms, sterile processing departments, outpatient surgery centers, dental clinics, and various healthcare and lab facilities.
Based in Carson, CA, Parter Medical Products Inc. provides contract Ethylene Oxide (EO) sterilization services. The company is ISO & EN certified and also manufactures quality, single-use, plastic laboratory products. It serves the healthcare, medical, and pharmaceutical research markets with items like petri dishes and specimen containers.
Based in Southern California, Parter Sterilization Services provides contract sterilization for medical device manufacturers. The company utilizes Ethylene Oxide and Electron Beam technologies to ensure product safety and compliance. PSS is FDA registered and maintains ISO certified quality systems for precise, reliable operations.
Based in League City, TX, Patho-Gen, LLC provides onsite biological decontamination services using a proprietary dry fog system. They specialize in hydrogen peroxide vapor for rapid and effective treatment of controlled environments, serving healthcare, pharmaceutical, biotech, and research industries.
Based in Santa Fe Springs, CA, Pro-Tech Design & Manufacturing provides complete medical device sterilization services, including validation and cycle development. The FDA & ISO 13485 registered company also specializes in contract packaging, assembly, and custom sewn medical products, offering comprehensive end-to-end solutions with over 40 years of experience.
Based in Macungie, PA, Sharp Services provides sterile manufacturing for clinical and small-scale commercial drug products. They offer terminal sterilization of products and diluents utilizing ventilator (air-over-pressure) autoclaves. This ensures the delivery of safest sterile solutions, supporting clients from preclinical development to market launch.
Spaulding Decon provides professional biohazard and crime scene cleanup services across the USA. Their certified technicians restore properties with discreet, compassionate support for accidents, deaths, property damage, and hoarding situations, offering same-day response.
SpecialtyCare, based in Brentwood, TN, provides clinical services to hospitals, focusing on surgical equipment management. They offer comprehensive sterile processing department (SPD) services, including decontamination, inspection, maintenance, and sterilization of surgical tools, ensuring the safety and efficiency of operating rooms.
Based in Long Beach, CA, SPSA (Sterile Processing Services of America) offers offsite surgical instrument sterilization services. They manage the entire instrument lifecycle, from soiled tray pickup to proper sterilization and timely delivery of vendor loaner trays, providing an innovative solution for hospitals and medical vendors.
SteriTek, Inc. provides high-volume E-beam and X-ray contract sterilization, R&D, microbiology, and cross-linking services. Specializing in sensitive materials, the company serves the medical device, biotech, pharmaceutical, and tissue product industries with facilities in Fremont, CA, and Lewisville, TX.
Stericycle provides end-to-end management and disposal of regulated medical waste streams for healthcare facilities, including local clinics, surgery centers, and hospitals. Based in Morton Grove, IL, the company focuses on ensuring workplace safety and compliance through its specialized services.
Andersen Sterilizers, Inc., based in Haw River, NC, provides in-house and contract ethylene oxide (EO) sterilization services for manufacturing clients. They utilize FDA-cleared EO-Flexible Chamber Technology for efficient terminal sterilization. Andersen also supplies EO sterilizer equipment to healthcare, veterinary, and research facilities.
Based in Mentor, OH, STERIS AST offers global contract sterilization and microbial reduction services for medical device and pharmaceutical manufacturers. They use diverse radiation and gas technologies like X-ray, E-Beam, Gamma, Ethylene Oxide, and VHP Steam, alongside comprehensive laboratory and packaging testing.
Based in Mentor, OH, STERIS provides comprehensive sterilization solutions for medical device, pharmaceutical, and biotechnology manufacturers. Services include contract sterilization via Gamma, Electron Beam, X-ray, Ethylene Oxide, and Vaporized Hydrogen Peroxide. They also offer sterile processing equipment, instrument cleaning chemistries, and sterility assurance products.
Based in Deer Park, TX, USA DeBusk provides comprehensive industrial decontamination and cleaning services for process equipment. They utilize advanced technologies and trained experts to mitigate waste and restore optimal efficiencies across various sectors, including heavy oil, light oil, and alkylation industries.
Komet Medical provides comprehensive packaging solutions, including labeling, for medical devices. They ensure compliant, sterile, and ready-to-sell products, supporting clients from initial concept to market. The company also manages complete documentation and assumes the role of Legal Manufacturer, offering full end-to-end services.
Based in Broadview Heights, OH, Sotera Health provides sterilization solutions, lab testing, and advisory services for the healthcare industry. Through its businesses like Sterigenics, it offers outsourced terminal sterilization and irradiation for medical devices, pharmaceuticals, and food safety across various technologies.
Based in Aurora, IL, Aftermath Services provides comprehensive biohazard cleanup and environmental remediation services. They specialize in crime scene, unattended death, suicide, hoarding, and narcotics cleanup, serving commercial, industrial, law enforcement, and residential clients across the US.
Based in Carlsbad, CA, Argonaut Manufacturing Services delivers contract manufacturing for life sciences, IVD, medical device, and combination products. They specialize in terminal sterilization, aseptic and non-aseptic fill-finish, and lyophilization. The company also offers analytical and quality control support for diverse product needs.
C.G. Laboratories, Inc. provides medical device sterilization validation, testing, and decontamination services. With over 40 years in business and ISO/CLIA certifications, they also offer contract packaging for sterile and non-sterile products. Consultants are available to assist with sanitization needs and ensure FDA compliance.
Based in Billerica, MA, ConSteril provides specialized validation services. The company assists clients in complying with current USA and International Standards for steam sterilization, specifically ISO 17665. These essential services ensure that sterilization processes meet stringent regulatory and quality requirements for various industries.
Fikes Infection Control Inc., based in Arlington, TX, provides services focused on preventing infection spread. They specialize in handling infectious materials and offer High Contact Surface Disinfection Service (HCSDS) and Equipment Disinfection. The company implements strict protocols to ensure safe environments and mitigate disease transmission.
Based in Hercules, CA, Pacific BioLabs is a Contract Research Organization (CRO) that provides gamma irradiation and other sterilization services. They assist clients with projects for pharm/biopharm manufacturing, drug development, and medical device testing. The company is FDA registered and ISO 17025 accredited, ensuring quality support.
PCI offers cleaning, sterilization, and process validation services for the pharmaceutical, biotech, and medical device industries. They also provide comprehensive technical support, including calibration, laboratory instrument services, and engineering consulting, to ensure compliance and operational excellence for clients.
Based in Pine Brook, NJ, Prince Sterilization Services, LLC provides contract sterilization for pharmaceutical and medical device industries. Their services include moist heat steam, low temperature vaporized hydrogen peroxide, dry heat sterilization, and depyrogenation. The company is FDA Registered, ISO 13485 certified, and cGMP compliant.
Based in Alpharetta, GA, Remington Medical operates as a full-service contract manufacturer specializing in medical devices. The company offers comprehensive solutions, including medical sterilization and packaging, to support device production for its clients.
SMC Ltd specializes in sterilization services for pharmaceutical and medical device products. The company assists clients with all sterilization validation processing activities, handling both standard and custom containers. They also provide sterile filling and analytical services, delivering custom solutions for single-use medical devices.
Sterigenics provides comprehensive industrial sterilization solutions for critical industries. Specializing in medical device, pharmaceutical, advanced applications, commercial, and food sectors, the company ensures product safety from conception to commercialization. Sterigenics U.S., LLC operates from Oak Brook, IL, delivering essential sterilization services.
Based in Seguin, TX, Texas Decon LLC provides comprehensive decontamination and bio-hazard removal services. They specialize in cleaning and disinfecting for businesses, manufacturing plants, and medical facilities, using licensed protocols and commercial-grade germicidal cleaners with fogging applications for thorough sanitation.
Vapos, LLC specializes in organic pasteurization services for nuts, spices, grains, food, and pet food products. Utilizing both steam and dry heat methods, the company provides essential sterilization to reduce pathogens for commercial and industrial clients. Based in Newman, CA.
Based in Imperial, PA, BGS US LLC provides radiation sterilization services, utilizing beta rays and e-beam technology. They specialize in sterilizing medical devices, medical and pharmaceutical packaging, and bioprocessing products. With over 40 years of experience, BGS US offers efficient, environmentally friendly sterilization solutions for diverse industries.
Based in Dallas, TX, Controlled Contamination Services (CCS) specializes in technical cleaning and disinfection for controlled environments. They provide comprehensive services for contamination control, particulate reduction, and microbial management in cleanrooms. CCS serves critical sectors like pharmaceuticals, biotechnology, and medical device manufacturing, ensuring adherence to stringent industry standards.
Infinity Laboratories provides high-quality, fast turnaround contract EO sterilization and validation services. With eight state-of-the-art facilities, they support pharmaceutical and medical device customers with product testing, cleanroom, and sterilization services. The company offers comprehensive solutions with an emphasis on communication and on-time delivery.
MedWaste Management provides comprehensive services for the safe and compliant collection, transportation, and treatment of regulated medical waste. They specialize in handling biohazardous materials, often employing various sterilization methods to ensure proper disposal for healthcare facilities and other generators.
STERIS IMS offers surgical device and instrument management services, including comprehensive repair for surgical devices, scopes, and instruments. They specialize in sterile processing and flexible scope solutions, ensuring infection prevention and operational readiness for medical equipment. The company also provides certified pre-owned devices to healthcare facilities.
Steritrans Corp, based in Humble, TX, is a provider of medical device sterilization services. They specialize in Ethylene Oxide (EO), Gamma Irradiation, and E-Beam sterilization. The company also offers laboratory services, including sterilization and packaging validation, along with microbiology testing, from its US facilities.
Based in Santa Ana, CA, VPT Rad LLC provides convenient and low-cost gamma sterilization services. Specializing in supporting small product research and development, the company caters to biomedical product sterilization needs and validation. VPT Rad offers high-quality sterilization solutions for products requiring radiation effects research.
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How to Choose a Company
- Verify Modality Expertise: Confirm the supplier's proven track record and facility accreditation for your required sterilization modality, whether it's ISO 11135 for ETO, ISO 11137 for Gamma Irradiation or E-beam, or specific requirements for moist heat sterilization, ensuring their process parameters align with your product's material compatibility.
- Assess Sterilization Validation Capabilities: Go beyond mere execution; evaluate their in-house or partner expertise in developing and executing sterilization validation protocols (e.g., PQ, OQ, IQ) and providing robust dose mapping data that will withstand regulatory scrutiny (e.g., FDA, notified bodies).
- Demand Specific Quality System Certifications: For medical devices, insist on ISO 13485 certification and, for contract sterilizers subject to FDA oversight, verify their FDA registration status and inspection history. Ensure their quality management system directly addresses control of the sterilization process.
- Scrutinize Sterility Assurance Level (SAL) Strategy: Understand their approach to achieving your target SAL (e.g., 10^-6) and how they manage bioburden reduction. Question how they handle worst-case scenarios and routine monitoring for consistent assurance.
- Evaluate Capacity and Redundancy: Confirm their actual chamber capacity, throughput, and their strategy for business continuity, including redundancy across multiple facilities or lines, especially critical for high-volume products or those with tight inventory windows.
- Red Flag: Lack of Transparency on Process Deviations: Be wary of suppliers who are vague about their process deviation handling, non-conformance reporting, or root cause analysis procedures. A robust quality system involves transparently addressing and resolving issues, not burying them.
- Insist on Robust Material Compatibility Testing Support: For novel devices or changes, ensure they can either perform or actively support third-party material compatibility assessments specific to the chosen sterilization method, as improper selection can lead to product degradation or failure.
Frequently Asked Questions
How do I determine the right sterilization modality for my medical device?
Selecting the correct modality (e.g., ETO, Gamma, E-beam) depends heavily on your device's material composition, package integrity, and heat sensitivity. You'll need to consider material compatibility studies, maximum allowable dose or temperature exposure, residual limits (for ETO), and the required Sterility Assurance Level (SAL). Many contract sterilizers offer consultation to help with this assessment.
What is 'dose mapping' and why is it crucial for radiation sterilization?
Dose mapping is a critical process for radiation sterilization (Gamma, E-beam) where dosimeters are placed throughout the product load to measure the absorbed radiation dose distribution. It's crucial because it verifies that all parts of the product receive the minimum required dose for sterility, while ensuring no part receives an excessive dose that could degrade materials or functionality. Regulatory bodies like the FDA require robust dose mapping as part of sterilization validation.
What specific data should I provide to a sterilization services company for an accurate quote and protocol development?
To receive an accurate quote and facilitate efficient protocol development, provide detailed product specifications (dimensions, weight, materials), desired Sterility Assurance Level (SAL), target turnaround times, typical bioburden levels, primary and secondary packaging details, and any pre-existing sterilization validation data or material compatibility reports. Also, specify regulatory market requirements (e.g., FDA, EU MDR).
What are the primary regulatory considerations when outsourcing medical device sterilization?
For medical devices, key regulatory considerations include ensuring the contract sterilizer is FDA registered (if applicable) and compliant with 21 CFR Part 820 (Quality System Regulation). You must also confirm their adherence to ISO 13485 for quality management and ISO 11135 (for ETO) or ISO 11137 (for radiation) for process validation. Your quality agreement with the sterilizer is paramount for defining responsibilities.
How do I manage ETO residual limits and what impact do they have on product release?
ETO sterilization requires careful management of residual Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol. Regulatory bodies (e.g., FDA, ISO 10993-7) set strict limits for these residuals based on product contact time and body exposure. Suppliers must have validated aeration cycles to reduce residuals to acceptable levels, and you'll need a robust testing program (e.g., gas chromatography) and hold times to ensure compliance before product release.
What's the difference between routine processing and sterilization validation, and why do I need both?
Routine processing is the ongoing execution of a validated sterilization cycle for your product. Sterilization validation (IQ, OQ, PQ) is the documented process of establishing, through objective evidence, that the sterilization process consistently delivers a Sterility Assurance Level (SAL) appropriate for the product and its intended use. You need validation before routine processing to prove the process works and consistently achieves sterility, and then routine processing maintains that validated state through strict adherence to parameters.