Sterilization of today’s pharmaceutical products, including drug / device combinations, 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 pharmaceuticals with complex ingredients.
The pharmaceutical sterilization process is precisely controlled by advanced electronics and monitored by advanced film dosimeters. We typically sterilize medical products in their final packaging, allowing the ability to ship direct to customers, thereby saving you time and money by reducing inventory and cutting down on shipping costs. 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 pharmaceutical sterilization process is the fastest sterilization method available in the marketplace!
Who Pharmaceutical Sterilization Is For:
E-beam pharmaceutical sterilization is a safe, effective, and efficient processing technology used to sterilize a wide variety of disposable medical devices and pharmaceuticals. Processing at E-BEAM is the most cost-effective method for low to medium density products, but not a good fit for extremely dense materials.
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.
- Class III controlled substances
- Active ingredients
- Drug/device comination products
- Ophthalmic products
- Proteins and enzymes
Advantages of e-beam over ETO (also referred to as EO, ethylene oxide, ethylene oxide gas):
- E-beam provides quick-turn terminal sterilization with simple, clean, on/off technology. There is no carcinogenic gas needed and there are no residuals, so 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.
- E-BEAM Services can provide step-by-step guidance for starting with e-beam, or the conversion from ETO to electron beam sterilization.
Advantages of e-beam over gamma:
- E-beam provides quick-turn terminal sterilization with simple, clean, on/off technology. There are no radioactive sources needed, so there are no security, transportation or disposal concerns.
- The supply of electrons will never be in danger of running out, unlike the source of gamma photons, Cobalt 60.
- E-beam has a faster dose rate than gamma, so there is a reduced risk of product damage. E-beam can even be used on sensitive products like pharmaceuticals and tissue products.
- E-BEAM Services can provide step-by-step guidance for starting with e-beam, or the conversion from gamma to electron beam sterilization.
Why it Matters to You:
|Fast turnaround||Less material degradation than gamma|
|Greater mixed lot flexibility||Uniform, precise, & controlled dosing|
|No residuals or quarantine||Environmentally friendly|
|Processed in original packaging||Expedited processing available|
|Cost effective for low to medium density products||Refrigerated/frozen sterilization available|
|Technical expertise and consultation services||Regulatory compliance (FDA, AAMI/ISO, GMP, EU GMP)|