The quick answer is NO!Unlike other sterilization methods, such as EtO and gamma, the e-beam process unloads pallets and places cases of product onto conveyer carts in a single layer.
The EtO sterilization method loads pallets of product into a chamber and that specific pallet configuration must conform to the validated process. In gamma sterilization, either a specific pallet configuration must be provided or a specific product “carrier” configuration must be arranged by the sterilizer. Customers with small volumes (who may not have enough product to fill a chamber or a number of carriers) or customers who have multiple sterilization parameters for a different products in a shipment, may face extra charges with these other technologies.
When you qualify your product with e-beam, a dosemap is done on a single case of product, and that specific packaging configuration is validated. Products with similar densities and packaging orientation can be grouped into “families” to reduce the number of dosemaps required.
E-BEAM Services customers typically separate their products by product code or family, and palletize them accordingly. One pallet of a specific product may vary in count from shipment to shipment. For e-beam processing, the specific amount of product on a pallet doesn’t matter since we break down the pallets. This flexibility that the e-beam process affords allows medical device manufacturers to process small to large batches based on their current needs and practice just-in-time inventory methods.
Have more questions? Give us a call, or ask Karen!