Tissue & Other Biologics Sterilization
Sterilization for Proteins & Advanced Regenerative Products
From life-saving tissue grafts to next-generation biologics, every product has one thing in common: there is no room for compromise.
For more than 40 years, E-BEAM Services has helped medical innovators safely sterilize complex products with precision electron beam technology. We are proud to innovate with tissue processors, biologics developers, medical device manufacturers, and researchers to develop consistent sterilization solutions tailored to each product’s unique requirements.
Whether you’re bringing a new therapy to market or scaling commercial production, our teams are here to partner with your teams and deliver reliable and redundant electron beam services.
E-Beam Sterilization Steps
Product is received and checked in
Boxes are loaded in a single layer on the conveyor
Product passes through a curtain of electrons and is sterilized
Product is released per ISO 11137/13485 and FDA guidelines
Product is promptly returned to you
While some biologically derived materials, including certain collagen-based products, tissue grafts and select lyophilized protein formulations, may be compatible with ambient temperature irradiation, many simply can’t tolerate conventional sterilization methods.
These highly sensitive formulations which include some peptides can benefit from refrigerated or frozen processing conditions. Cold-chain irradiation capabilities, including refrigerated and dry-ice processing, help minimize thermal exposure and support product integrity throughout processing.
In this process, the electron beam is killing pathogens without significant degradation. Our facilities are designed to support refrigerated, frozen, and specialty logistics so product quality is maintained from arrival through shipment.
E-beam cold sterilization is a safe, effective, and efficient processing technology used to sterilize a wide variety of tissue products.
Electron beam sterilization is an ideal solution for many soft tissue applications where precision and product integrity matter.
We process products including:
- Dermal allografts and decellularized dermal matrices
- Extracellular matrix (ECM) products
- Amniotic membrane and placental tissue products
- Dermal allografts
- Organs for decellularization
- Collagen matrices and grafts
- Wound healing and regenerative medicine products
- Corneal tissue
- Connective tissue products
- Other biologic and tissue derived products
Every application is evaluated individually to determine the appropriate dose and processing parameters.
Our team also supports manufacturers and tissue processors working with hard tissue products requiring dependable sterilization.
Applications include:
- Demineralized Bone Matrix (DBM)
- Cortical and cancellous bone allografts
- Structural bone grafts
- Bone tissue products
- Cartilage allografts and cartilage-derived products
- Bone void fillers
- Orthopedic tissue-derived implants
- Joint preservation and reconstructive grafts
- Other hard tissue and regenerative orthopedic products
Because every material responds differently to radiation, our specialists work with customers to optimize the process before production begins.
Strategic Electron Beam Expertise
Most customers don’t come to us because they’re experts in electron beam technology. They come because we are. Our scientists and engineers work alongside your team to determine:
- Is electron beam the right technology?
- What dose is appropriate?
- How will the material respond?
- What validation is required?
- How can we scale from R&D to commercial production?
That’s why many of our customers consider E-BEAM Services an extension of their own engineering and regulatory teams.
How does E-Beam Sterilization Work?
The e-beam inactivates microorganisms either by causing microbial death as a direct effect of the destruction of a vital molecule or by an indirect chemical reaction. Advanced electronics precisely control the use of electrons in the sterilization of medical devices and pharmaceuticals.
The process involves accelerating a beam of electrons to near light speed where it passes through a scan chamber and then transitions into a curtain of electrons.
Materials moving through the chamber on a conveyor system are showered with these high-energy electrons, which penetrate the material with a precise, predetermined dose.
As the largest contract electron beam provider in the U.S., we offer capacity for large volume processing and provide a team of experts to deliver support.
Why E-BEAM Services?
For more than four decades, we’ve built our reputation on solving complex processing challenges that many providers simply can’t.
Our customers choose E-BEAM because of our:
Whether it’s improving material performance, ensuring sterility, or helping bring a breakthrough therapy to market, electron beam technology changes products for the better.
At E-BEAM Services, we’re proud to be the partner behind those transformations.
Speak with our team and enter to win a free experiment!
Single dose material exposure less than 100kgy