Tissue Sterilization
Interested in learning more about sterilizing your biopolymer and tissue products? We can help!
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.
E-Beam Sterilization steps
Product is received and checked in
Product is 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
E-Beam Sterilization Applications
Soft Tissue Products
Electron beam sterilization (e-beam sterilization) is a safe, effective, and efficient processing technology used to sterilize a wide variety of soft tissue products, including:
- Skin
- Membranes
- Organs
- And more
E-Beam’s sterilization and decontamination methods are the most efficient and proven solutions in the industry.
The E-Beam method of soft tissue sterilization uses a process that is precisely controlled by advanced electronics and monitored by advanced film dosimeters.
The rapid sterilization process and low cost pricing allows you to practice just-in-time inventory by scheduling shipments when you need them, as often as you need them.
E-BEAM Services prides itself on delivering solutions that provide safe, standardized, and effective processing while maintaining product integrity. With our experienced team of electron beam experts, we can guide you through the regulatory requirements needed to market your sterile soft tissue productsw. Validation is consistent with ANSI/AAMI/ISO guidelines, FDA Standards, and GMP Compliance.
Hard Tissue Products
Sterilization of today’s hard tissue products, including bones and tendons, is a delicate step in the production process.
E-BEAM Services prides itself on delivering solutions that provide safe, standardized, and effective processing to maintain product integrity. The quick dose rate, controlled precise dosing, and ability to sterilize temperature sensitive products efficiently, makes e-beam processing the preferred technology for hard tissue products.
The hard tissue sterilization process is precisely controlled by advanced electronics and monitored by advanced film dosimeters.
The rapid sterilization process and low cost pricing allows you to practice just-in-time inventory by scheduling shipments when you need them, as often as you need them. The E-beam hard tissue sterilization process is the fastest sterilization method available in the marketplace!
Refrigerated/Cold Sterilization
Cold sterilization enables low temperature molecular stabilization protection — for products that contain heat-sensitive ingredients and yet require sterilization or bioreduction.
Refrigeration can be provided at a range of 1° to 5°C, and frozen storage is offered at a range of -24° to -18°C. Additionally, same-day turnaround using the customer’s own refrigerated vehicles is available.
Our process 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 allows you to practice just-in-time inventory by scheduling shipments when you need them, as often as you need them.
The processing is completed in just minutes–this is only possible with e-beam! This means your product spends the least amount of time removed from cold storage as possible, so the temperature increase is minimal.
E-beam cold sterilization is a safe, effective, and efficient processing technology used to sterilize a wide variety of tissue products.
Why E-Beam Sterilization Matters to You
- Fast turnaround
- Greater mixed lot flexibility
- No residuals or quarantine
- Processed in original packaging
- Cost effective for low to medium density products
- Technical expertise and consultation services
- Less material degradation than gamma
- Uniform, precise, & controlled dosing
- Environmentally friendly
- Expedited processing available
- Refrigerated/frozen sterilization available
- Regulatory compliance (FDA, AAMI/ISO, GMP, EU GMP)
Are you ready to explore E-beam technology?
Contact us to speak with one of our Technical Services reps, or visit our extensive reference library to learn more E-beam sterilization.