Pulse Sterile

Pulse Sterile

Your Simply Sterile Solution Provider

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Sterilization Service Provider

We provide third party sterilization services for a variety of clients big and small.  We work with you to get your products sterilized in the simplest way possible for you.

Cutting Edge Technology

Our Digital Sterilization Tracker validates every package treated with our system ensuring the highest level of tracability.

Rapid treatment times

Our high speed treatments mean you no longer are waiting days, weeks or months to get your devices to market.

Making the Transition

We work hard to design and implement FDA Compliance


Thinking about changing sterilization service providers? Designing a new product for market? Tired of the delays associated with your current Sterilization Service Provider? Pulse Sterile is here to help. Compatible with almost all plastics, metals and organic materials, Pulse Sterile’s next generation advanced electron beam sterilization is fast, reliable, economical, it’s Simply Sterile. From our real time article level dose tracking to our advanced logistics, we make getting your devices sterilized and to market as simple as possible. We are familiar with the challenges of adopting a new sterilization modality. We are here to help get your product safely sterilized and to market with as little pain for the Quality Assurance department as possible.  Working with the FDA, and embracing the newest simulation assisted product certification, Pulse Sterile’s in house QA/QC and Regulatory Compliance departments are here to help. We provide below our operational roadmap to guide your product through the process to market.


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We are here to help you transition

We have a simple roadmap to help you transition from your existing sterilization service provider to our Simply Sterile Solution

Step 1 Step 2 Step 3 Step 4 Step 5 Step 6

New Article Review

Send us your item that you desire to be sterilized. We will conduct a review of the article, materials, packaging, and dosimetry needs. Need cleaning, preparation, packaging? We will review those needs and recommend packaging solutions to fit your product.


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Video Review


We will schedule a video conference call between your QA people and our QA people. Feel like visiting the plant in person, we will be glad to have you come tour the treatment plant and distribution center. Following the review and completion of our product questionnaire, we will specify the details pertinent to your product lines. Customers are encouraged to review our ISO 9001, 13485, 11137, 11607 and other calibration/certification documentation at this time.


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Modeling and Simulation

We will model your medical device and packaging and optimize a treatment solution for your specific product. Our advanced modeling and simulation can predict Sterility Assurance Levels, material changes, product lifetimes, chemical changes, and many other parameters of interest.

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Procedure Development

We will develop a specific treatment procedure for your medical devices for our machines. We will develop a pre and post treatment solution which maximizes the efficacy of our treatment and value for your bottom line. 

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Process Validation

We will proceed to treat your product and establish the required statistical data needed to validate the SAL has been achieved. Our in house QA department has NIST Traceable dosimetry solutions on hand to validate our Real Time article level dose verification. 

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Product Testing

We maintain an entire NIST traceable testing lab capability for both biological, chemical, and physical testing. If necessary, In house product materials testing is available to our customers including physics parameter measurements, chemical leaching, yellowing, and advanced aging testing.

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