Feasibility studies provide basic information regarding a product’s radiation compatibility. They are utilized often at the design/engineering stage of product development to ascertain whether radiation will enhance or adversely affect a product or its components. These studies are less costly than other more extensive types of testing and frequently can be completed more rapidly.

Specific dose studies are undertaken to determine the effects of radiation upon products at various tightly-controlled dose ranges. Normally, the dose range is designated as a “specific” dose plus or minus 10% (for example 25 kGy +/- 10%). Tighter dose tolerances are product-dependent and require evaluation prior to processing.

Maximum dose tests are performed to determine the highest dose of radiation to which a product can be exposed without losing its essential functional and cosmetic properties. These tests are usually run at several different high doses to pinpoint as closely as possible the highest acceptable processing dose. Many manufacturers also perform testing at double their normal production maximum dose to analyze whether they can re-sterilize products should re-work situations occur in the manufacturing process which would result in double the normal sterilization dose.

Verification dose testing establishes the routine production minimum sterility dose for a new product or re-validates an established product’s minimum dose. The appropriate minimum dose is determined by an electron beam dose challenge to a bioburden analysis performed at a microbiological laboratory. This testing is performed in accordance with accepted AAMI/ANSI/ISO standards for establishment of the minimum dose (Method 1, Method 2, VDMax, etc.)

Quarterly dose audits are performed to assure that the Verification Dose established for a product through the testing method above is still appropriate and effective in eradicating inherent bioburden. It assures that product is appropriately sterilized at the minimum dose established in the Verification protocol and that the inherent product bioburden has not changed in the manufacturing process.

Dose mapping is accomplished using full cases of product to establish critical routine processing parameters. The first task it to determine the most efficient and consistent method of orienting cases of product on the BeamOne carrier system. This orientation must result in dose delivery to the product which is equal to or higher than the minimum required dose for sterility and lower than or equal to the maximum allowable dose in order to protect product integrity. The second task of a dose map is to establish the mathematical relationship between doses of radiation received inside the product box and the dose received at a routine monitoring position outside of the product case(s).

Electron beam processing has been employed to impart a variety of commercially valuable physical property enhancements to many industrial, medical and consumer products. This process, known as crosslinking, increases the molecular weight of the polymer. Typical improvements can include increased tensile strength, increased impact strength, increased heat deflection and increased solder iron resistance. Electron beam is thus a proven means for improving the performance properties of thermoplastics, elastomers, and other materials, thereby extending their utility.

The Regulatory and Quality Assurance Management team at BeamOne offers decades of combined experience in the areas of materials analysis, product validation, special processing requirements and protocols, FDA/regulatory compliance, pre-market filings, and manufacturing challenges. Our industry experts are able to assist customers with all phases of product development related to electron beam sterilization and can serve as consultants every step of the way in bringing new products to market or working through issues with existing products. Please call for specific information and price quotations for our consulting services.

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