A properly sterilized device is what turns a well-designed product into one that’s truly ready for patients. Pro-Tech Design manages the full sterilization process for our customers, from cycle development and validation to EO, gamma, and steam sterilization. Our in-house ISO 17665 certified steam sterilizer is paired with trusted third-party partners for EO and gamma, so you get the right method for your device without sacrificing quality or control.
Every sterilization program we manage is backed by real, specialized expertise. Our team of microbiologists brings deep experience in medical device sterilization, reviewing cycles and sterility data so you can move forward with full confidence. We also bring decades of relationships with trusted third-party sterilizers, giving our customers reliable access to sterilization capacity even when it's in high demand.
Quality is a discipline we apply to every cycle, every report, and every partner we work with. Our Quality Assurance group audits all our sterilization contractors biannually, tracking performance with detailed scorecards to hold every partner to the same high standard. We also provide ongoing regulatory support and give customers 24/7 access to cycle data and certificates through our online portal.
With decades of experience in medical device packaging and sterilization, we know the process must be both compliant and efficient. We design programs around your product's specific needs, from materials and density to sterilization method. Often, we can leverage our foundation of existing, validated work to speed you to market and reduce costs. There's no need to start from scratch or pay for sterilization capacity you don't need.
We sterilize implantable and non-implantable medical devices using ethylene oxide, gamma radiation, or steam, so you choose the method that fits your product.
At Pro-Tech, we’ve refined our EO process to balance efficacy, cost, and turnaround, so you get a program built on real, applied experience. We run mixed loads through our iPCD-based product family, so customers can adopt into existing data and pay a fraction of the cost of running a dedicated cycle. Adoption studies follow recognized standards such as ISO 11135 and AAMI TIR 28, supplemented by product-specific testing, including bioburden, LAL, comparative resistance, and EO residual studies per ISO 10993-7.
We sterilize medical devices using both gamma and e-beam, working with experienced sterilization partners across the country to reduce shipping costs and minimize the risk of damage in transit. Radiation sterilization offers fast turnaround and leaves no chemical residuals, making it a strong option for devices that can tolerate the dose. Our team guides you through the full process, from establishing your product family to performance qualification of your dose, with ongoing dose audit support along the way.
Our Santa Fe Springs, CA facility is an ISO 17665 certified steam sterilizer, giving you added speed and control over your timeline with sterilization performed entirely in-house. Our 6 and 56 cubic foot chambers run clean steam, GMP cycles, with Air-Over-Pressure (AOP) capability for liquid products like filled containers, tubes, vials, and syringes. Our 6-cubic foot chamber also offers Steam-Air-Mix (SAM) for high-pressure exposure and cool down. It’s one more way we can support your device from packaging through final sterilization, all under one roof.
Find answers to frequently asked questions or contact us to start a conversation.
Sterilization is a critical process that occurs after the medical device has been assembled and placed in its final packaging. At this point, the device and its packaging may be contaminated with microorganisms, which can compromise the sterility of the device and potentially harm the patient. That’s why sterilization methods, such as ethylene oxide, gamma radiation, and steam, are used to eliminate any potential microbial contamination and ensure the safety and effectiveness of the device.
Sterilization comes with some of the following benefits:
Packaging requirements for sterilization depend on the specific method of sterilization being used and the type of medical device being sterilized. However, there are some general packaging requirements that apply to most sterilization methods.
First, the packaging must be compatible with the sterilization method being used. For example, ethylene oxide sterilization requires gas-permeable packaging materials, while radiation sterilization may require different types of packaging materials.
Second, the packaging must be designed to protect the medical device from damage during sterilization and transportation. This may involve using cushioning materials or designing the packaging to withstand certain levels of pressure or vibration.
Third, the packaging must be designed to maintain the sterility of the device after sterilization. This may involve using sterile barriers or double-wrapping to prevent contamination during storage and transportation.
Fourth, the packaging must be clearly labeled with all necessary information, including the sterilization method used, the date of sterilization, and any relevant regulatory or compliance information.
At Pro-Tech Design, our team of experts works closely with clients to design customized packaging solutions that meet the specific requirements of their medical devices and the sterilization method being used. Our goal is to ensure that the packaging is optimized for both the sterilization process and the transportation and storage of the medical device while maintaining sterility and complying with regulatory requirements.
We offer both in-house and third-party sterilization services, depending on the specific needs of our clients.
We are an ISO 17665 registered steam sterilizer and provide in-house steam sterilization services at our facility in Santa Fe Springs, CA. This helps us reduce leads times, control costs, and enhance flexibility.
We also work with 3rd party sterilizers who are experts in EO and Gamma Sterilization. FDA and EPA regulators have specific requirements that guide the health and safety of these sterilization techniques. As a result, we recommend working with experts in these forms of sterilization. We have strong relationships with EO and Gamma sterilizers and we are able to bundle different customer’s devices into single pallets. This reduces costs and timing for each customer and helps get them access to sterilizers, which can be difficult.
Choosing the right partner for medical device sterilization is crucial to ensure that products are effectively sterilized, compliant with regulatory requirements, and delivered to the market in a timely and cost-effective manner. Pro-Tech offers a range of contract sterilization services, and working with us offers several benefits, including:
Ethylene oxide (EO) cycle validation is a critical step in the sterilization process for medical devices using ethylene oxide gas. EO cycle validation is the process of verifying that the sterilization cycle is capable of effectively sterilizing medical devices and achieving the desired level of sterility assurance.
The EO cycle testing process typically involves the following steps:
EO cycle validation is a critical step in ensuring the safety and effectiveness of medical devices that are sterilized using ethylene oxide gas. It is also required by regulatory agencies such as the FDA to demonstrate compliance with regulatory requirements.
Medical devices require effective sterilization to ensure that they are free from harmful microorganisms before use. There are several methods for sterilizing medical devices, such as moist heat (steam), dry heat, radiation, ethylene oxide gas, and vaporized hydrogen peroxide. Other sterilization methods include chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.
Terminal sterilization is a process of sterilizing medical devices at the end of the manufacturing process, typically just prior to use. There are several benefits of terminal sterilization, including:
EtO and EO both stand for Ethylene Oxide, which is a colorless and flammable gas that is commonly used as a sterilization agent for medical devices. Ethylene oxide is a highly effective sterilant that is capable of penetrating the packaging and materials of medical devices to kill microorganisms such as bacteria, viruses, and fungi.
To learn more about EO sterilization and how it’s used in medical device packaging, visit this page.
