Packaging & Sterilization
Ready for Market
Bringing a medical device to market involves far more than manufacturing.
Ensuring product integrity, sterility, and compliance throughout shipping, storage, and use is critical – and presents its own set of challenges for medical device companies.
At Harmac, our fully integrated Packaging and Sterilization services help customers navigate these complexities with confidence, delivering safe, sterile, and market-ready products every time.
How We Help
We collaborate closely with customers to develop packaging solutions that protect device integrity while optimizing costs and meeting regulatory requirements.
Our extensive experience includes both new packaging medical design and redesigns for existing products, with a focus on maintaining sterility, enhancing usability, and driving operational efficiency.
Through partnerships with leading thermoforming companies and sterilization providers, we offer a fully integrated, end-to-end solution that simplifies the entire packaging and sterilization process.
Medical Device Sterile Packaging Experience
Harmac’s packaging capabilities cover a comprehensive range of options to meet the diverse needs of single-use medical devices. We offer sterile barrier packaging solutions with finished device labeling, as well as high-speed, fully automated items for pouch sealing, tray sealing, form-fill-seal, and bulk packaging – all designed to maintain product safety and consistency through every stage of handling and distribution.
Automated Medical Device Packaging, Testing and Validation
To ensure every package performs reliably, we conduct extensive testing and validation, including tensile strength, burst testing, seal integrity, transportation simulation, and aging studies. These validations ensure that devices remain sterile, secure, and effective throughout their shelf life and supply chain journey.
Medical Device Labeling Services
Our packaging services extend to comprehensive device labeling solutions. We support label design, production, barcoding, logo placement, and printing, ensuring that every product is clearly identified, accurately labeled, and fully compliant with global regulations.
Sterile Barrier Packaging Solutions
Harmac also offers a full suite of medical device sterilization packaging solutions, including Ethylene Oxide (ETO), Gamma Radiation, and Electron-Beam (E-Beam) sterilization. We work closely with customers and sterilization partners to select the most appropriate method for each device, balancing regulatory requirements, material compatibility, and cost considerations.
By partnering with us, customers simplify the complexities of packaging and sterilization while ensuring that devices reach patients safely, are sterile, and ready for use.
Your Questions Answered
Q&A
We offer a comprehensive selection of medical packaging options configured to fit your automated throughput requirements and device shape. Our capabilities include precision heat-sealing of pre-formed pouches, custom rigid thermoformed tray sealing with Tyvek lidding, and high-efficiency form-fill-seal (FFS) automated web packaging. These solutions provide strong, reliable sterile barriers that stand up to the logistics loop. We can also assist with designing packaging systems that are ideal for the required sterilization modality in order to maximize sterilization efficiency.
We manage the end-to-end sterilization lifecycle loop for our customers by partnering with premier global sterilization providers and following state-of-the-start international standards. Our engineering teams handle full sterilization validations across multiple modalities, balancing material compatibility:
- Ethylene Oxide (EtO): Excellent for complex assemblies with internal lumens or heat-sensitive materials, and for products that are not compatible with radiation sterilization. We ensure the validations are compliant with ISO 11135.
- Gamma Radiation: Highly penetrative and efficient for uniform, high-density products and materials. We ensure the validations are compliant with ISO 11137.
- Electron-Beam (E-Beam) Radiation: Delivers rapid dosing cycles with minimal material degradation polymer implications. We ensure the validations are compliant with ISO 11137.
We design and coordinate full packaging validation protocols in compliance with ISO 11607 standards. Our evaluation loops include real-time and accelerated aging studies, combined with physical challenge testing such as dye penetration analysis, bubble emission testing, and tensile peel-strength measurements. These tests confirm that your device maintains its sterile barrier throughout its entire labeled shelf life. We are ready to also assist you with design verification or functionality testing to support that your device is compatible with the sterilization process and usable throughout the labeled shelf-life.
We partner with certified testing laboratories to subject packaged devices to rigorous transit simulations, including ASTM and ISTA distribution protocols. By exposing shipping configurations to controlled vibrations, drop tests, compressions, and extreme temperature variations, we verify that the primary sterile barrier and secondary packaging arrive at the clinical environment in pristine condition.
We manage dose auditing programs (for radiation-sterilized products) and product bioburden monitoring (for EtO sterilized products) following international standards like ISO 11137 and ISO 11737-1. We also perform viable environmental monitoring in our ISO Class 8 Cleanrooms to monitor and control contamination levels to add further confidence in our contamination control program. We routinely perform sterilization requalification assessments / annual reviews, requalifications, and adoption assessments to further support ongoing sterility assurance. We make sure that your sterility assurance records are audit/inspection ready.
Let’s work together
No matter where you are in your manufacturing process, we can help. If you need direct access to our engineering team, you are in the right place.
