E-BEAM Blog

Introducing STAT Sterilization Validation Services

Infographic displaying the new E-BEAM Services STAT Sterilization Validation optionsIn the world of medical device and pharmaceutical manufacturing, timely and accurate sterilization validation is crucial. However, the validation process often poses challenges, causing delays in getting products to market. That’s where E-BEAM Services’ STAT Sterilization Validation services come into play!

 Designed to expedite the validation process, these services offer medical device and pharmaceutical manufacturers a range of options to quickly and efficiently validate their products for sterilization using electron beam technology.

Expedited Processing Options

STAT Sterilization Validation services provide manufacturers with a variety of expedited processing options to meet their specific needs. With standard turnaround time set at two weeks, manufacturers now have the flexibility to choose from expedited options such as one week, three days, next day, and even same-day processing. This allows them to significantly reduce the time it takes to validate their products and get them safely on the market.

The Power of Electron Beam Technology

At the core of STAT Sterilization Validation services is the utilization of electron beam (E-beam) technology. E-beam sterilization is a safe, effective, and efficient method used to sterilize a wide range of disposable medical devices and pharmaceuticals. With its ability to penetrate packaging materials and rapidly sterilize products, E-beam technology offers a reliable and cost-effective solution for manufacturers seeking expedited sterilization validation.

Market Demand

The demand for expedited sterilization validation services has never been higher. Manufacturers are under pressure to swiftly bring their products to market while ensuring the highest level of safety for end-users. Traditional modalities like ethylene oxide gas and gamma sterilization can be time-consuming and present limitations. STAT Sterilization Validation services address these challenges by providing expedited options that prioritize both speed and safety, empowering manufacturers to meet market demand efficiently.

Gaining a Competitive Edge

By offering a range of expedited processing options, these services enable manufacturers to stand out in the market by reducing time-to-market while maintaining the highest standards of sterilization validation. With a streamlined process, manufacturers can confidently navigate the complex regulatory landscape and get their products into the hands of consumers in need, faster than ever before.

STAT Sterilization Validation services offer a lifeline to medical device and pharmaceutical manufacturers in their quest to bring safe and effective products to market quickly. By leveraging electron beam technology and providing expedited processing options, these services empower manufacturers to navigate the complexities of sterilization validation easily and efficiently. With STAT Sterilization Validation, you can be confident that your products will be validated promptly, allowing you to make a positive impact on the lives of consumers in need.

Want to learn more?

Ready to explore how STAT Sterilization Validation services can help expedite your product’s sterilization validation process? Contact us to learn more about our expedited options and discuss how we can support your specific needs.

Posted in E-Beam, Product Validation, Sterilization | Comments closed

Who Doesn’t Love A Philly Cheesesteak and Talking about the Science of Labware?

E-BEAM Services will be sharing sterilization expertise in Philadelphia in just a few weeks at Pittcon Ⓡ – the largest international laboratory science conference and exposition in March
18-22, 2023

E-BEAM is a great fit for sterilizing or bioreducing labware products. E-beam sterilization (or bioreduction) is a safe, effective, and efficient processing technology used to sterilize a wide variety of disposable medical devices. Processing at E-BEAM is the most cost-effective method for low to medium-density products.

We are pretty excited to see the latest advances in lab science and diagnostics that this show has to offer. We love science and partnering with our customers to create unique products that
make the world better (in this case the medical sector). Many of these revolutionary products have bioburdens that could cause problems with their end usage. E-BEAM Services provides
fast, effective, precision-controlled, e-beam bioreduction services designed to safely reduce or eliminate microbial organisms. This sterilization alternative requires less regulatory compliance
and is a good option for manufacturers who are not claiming terminal sterility, but who want the extra assurance of a cleaner product.

Products requiring a bioburden reduction are not subject to the same regulatory requirements as sterilization but are processed in the same manner as sterilization products, so you see the
same benefits. Our method of bioreduction uses a process that is precisely controlled by advanced electronics and monitored using state-of-the-art film dosimeters. We typically process products in their final packaging, giving us the ability to ship direct to customers, thereby saving you time and money.

The rapid sterilization process and low-cost pricing allow you to practice just-in-time inventory by scheduling shipments when you need them, as often as you need them. The E-beam technology provides quick-turn terminal sterilization with simple, clean, on/off technology. There is no carcinogenic gas needed and there are no residuals, so the product is able to be immediately released for distribution. E-BEAM Services is capable of handling any shipment size, from single boxes to multiple truckloads, and no expensive breathable packaging
is required.

As a company that prides itself in “giving back” another thing we really admire and support about Pittcon- proceeds from each and every Pittcon directly fund science education and
outreach. Over 90% of Pittcon’s net profit goes on to fund primary and secondary education, continuing education, scholarships, laboratory improvements, and outreach
activities. That can really drive innovation! Plus, as a bonus, it’s in Philly and who doesn’t love a good Philly cheesesteak?

If you are interested in learning more about how E-BEAM Services can support your labware sterilization needs: contact us

About Pittcon:
Pittcon is a dynamic, transnational conference and exposition on laboratory science, a venue for presenting the latest advances in research and scientific instrumentation, and a platform for
continuing education and science-enhancing opportunity. Our aim is to advance scientific endeavor through collaboration, bringing together a world of knowledge to impact, enrich, and inspire the future of science. Pittcon is a catalyst for the exchange of information, a showcase of the latest advances in laboratory science, and a venue for international connectivity. Over 90% of Pittcon’s annual net profit funds scientific grants, education, laboratory improvements, and outreach. pittcon.org

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How hot is my product going to get when it’s processed with e-beam?

How hot is my product going to get when it is beamed? A great question to be sure, and one that can be surprisingly difficult to answer…

Electron beam irradiation is a really fast process and delivers a lot of dose quickly. Dose being energy means there is a temperature rise in the product.

Let’s look at the theoretical part first, as that is the easy part.

The equation is ∆𝑇=1000 𝑥 𝐷 / 𝑐

ΔT is the change in temperature in °C

D is the dose in kilogray (kGy) = 1 kJ/kg; this has to be converted to Gray (J/kg) for the units to cancel and is therefore multiplied by 1000.

c is the specific heat of the material absorbing dose in J/(kg°C)

Now an example using data from engineeringtoolbox.com https://www.engineeringtoolbox.com/specific-heat-polymers-d_1862.html

For polycarbonate, a commonly sterilized polymer, using a 25 kGy dose, the math looks like:

1000 𝑥 25 𝑘𝐺𝑦 / 1100 𝐽/(𝑘𝑔 °𝐶)= 23°C

Another example is polyethylene that is commonly crosslinked, and using a 200 kGy dose, the math looks like:

1000 𝑥 200 𝑘𝐺𝑦 / 1550 𝐽/(𝑘𝑔 °𝐶)= 129°C

Wait! The melt point of polyethylene 135°C, how can polyethylene be dosed to crosslink it? Won’t it just melt? The answer is of course it would melt if it was dosed at 200 kGy in a single increment, therefore, when products are irradiated to “higher” dose levels, the dose is delivered incrementally or fractionally to the product. For example, we dose polyethylene parts at 20 kGy per pass for 10 passes. In between each pass is a delay of minutes before the next 20 kGy is delivered (which only takes a few seconds).

This time between passes allows for cooling, and a typical temperature that the parts may get to at 200 kGy may only be 75°C, a 50°C increase in temperature. How much cooling occurs and the ultimate temperature a product may reach is dependent on a number of factors, which makes it difficult to predict. It is also why we like to do qualification runs as close to what production settings will be to account for some of the factors beyond dose.

For sterilization applications, the maximum dose a product may receive within a case needs to be considered. With metals that may have a lower heat capacity, the temperature rise could be dramatic.

In special cases, different techniques of cold processing can be used involving refrigeration, freezing, or dry ice, but that is for another blog!

Posted in Crosslinking & Polymer Modification, E-Beam, Processing Capabilities, Processing Capabilities, Sterilization | Comments closed

Next Stop, The Foam Expo

Olivia RadcliffeNext stop, Michigan!

The Foam Expo provides the foam industry with solutions for end-user markets. Providing world-class contract electron beam processing so our customers can make great products is our jam. When it comes to foam, we use high-speed reel-to-reel equipment with the capability to handle (almost) all applications, ranging from films as thin as 5 mils (0.005”) to sheet as thick as 0.25 inches.

Read More »

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E-BEAM heads south to the IME South in Charlotte

 

E-BEAM is excited to be exhibiting at the inaugural MD&M South in Charlotte, North Carolina from June 14, 2022, to June 16, 2022– the Southeast’s most comprehensive medical design and manufacturing event. We’ll be in booth #1843– stop by and tell us about your latest project. We’d love to be a part of your success story! If you would like to request an appointment with our attendees below, please submit a request via the form to the right. Read More »

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We’re off to Dallas, y’all!

Dallas Texas Skyline

This week we will be in Dallas at the Wire Expo, talking about crosslinking and of course electrons (a favorite 😉). The WAI Operations Summit & Wire Expo is held biennially in a different industry hub within the U.S. for the wire and cable manufacturing industry. Read More »

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E-BEAM Tech Services Duo to Attend MD&M West

E-BEAM Services does Anaheim, CAThe E-BEAM Technical Services dynamic duo of Olivia Radcliffe and Dr. Gustavo Varca are hitting the road to answer any and all questions related to e-beam sterilization. This pair of experts will be at the Medical Device and Manufacturing (MD&M) West Show from April 12-14 in sunny Anaheim California. Read More »

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E-BEAM Services to Participate in Plastics Technology Expo 2022

PTXPO Logo

 

Our team of electron experts is excited to be heading to the Plastics Technology Expo (or PTXPO, as the cool kids say) March 29-31. As polymer product development and modification collaborators, this new tradeshow connecting the entire North American plastics market under one roof is definitely in our wheelhouse.

It has been a long time since we have been able to exhibit at a full-scale industry event of this size. Since polymer modification is our jam you can imagine how geeked up we are for a comprehensive plastics tradeshow. At E-BEAM Services, we modify polymers and other materials using electron beam technology (hence our name…) to help clients make great products that our world wants and needs. Read More »

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Q&A with Tech Services | E-beam Bioreduction and Food Processing

 

Join the E-BEAM Tech Services duo of Olivia Radcliffe and Dr. Gustavo Varca as they discuss e-beam bioreduction and food processing.

 

(TL;DR: E-beam technology can be used to sterilize or bioreduce food products such as beef and fresh produce. At E-BEAM Services, we don’t process fresh foods, but we do process some food products such as spices. Bioreduction essentially delivers a sterilization-level dose for product that does not need to be labeled as “sterile.” E-beam bioreduction is a good fit for food products because it offers fast turnaround time and a quick dose rate so as to minimize degradation to important qualities such as taste and smell.)

 

Olivia: Alright! Hey everyone, I’m Olivia Radcliffe. I’m the Marketing and Technical Services Specialist here at E-BEAM Services. That is Nola sleeping behind me. She will snore. We’ll see how much it gets picked up on the mic. Hopefully, Gustavo won’t be snoring. So I’ll let you can give your spiel about who you are, what you do for E-BEAM.  Read More »

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Q&A with Tech Services | Sterilization of Specialty Products

 

Join the E-BEAM Tech Services duo of Olivia Radcliffe and Dr. Gustavo Varca as they explore some of your FAQs about sterilizing specialty products.

 

(TL;DR: Beyond processing truckload quantities, e-beam technology is a good fit for specialty products that have small lots and vary from shipment to shipment, like 3D printed products and parts for bone replacements. E-beam is a good fit for 3 main reasons: 1. E-beam has the capability to deliver a very precise dose, 2. E-BEAM Services has temperature control systems in place that can be used for sensitive products, 3. E-BEAM has fast turnaround time options, which can be utilized in quick-turn scenarios, such as personalized products for surgeries, etc.)

 

Olivia: Alright! Hey everybody, I’m Olivia Radcliffe and I am here with Dr. Gustavo Varca. Gustavo, let you go ahead and introduce yourself a little bit here.

Gustavo: Hello everyone. Good morning. Good afternoon. Depends on where you are. I am Dr. Varca also known as Dr. V and I’m going to be speaking with you guys a little bit about radiation technologies.

And today I think we have a couple of questions again, that people send to us and I’ll be more than happy to answer them. Read More »

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