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Technical Articles

1. SMARTDOSE™ ELECTRON BEAM STERILIZATION – SENSITIVE MATERIALS ROUTINELY PROCESSED
NUTEK Corporation has special facilities and processes for the validation sterilization of sensitive materials. Sensitive materials include mammalian tissues (allografts), polymers used in advanced wound closure or tissue bonding systems and other materials that show unacceptable degradation when exposed to radiation at room temperatures.
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2. CHANGING FROM GAMMA TO E-BEAM
Ordinarily, changing from a validated gamma sterilization process to E-beam Sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit.
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3. E-BEAM VS. GAMMA STERILIZATION
APPLES n’ APPLES: Many of the sterilization issues concerning gamma and electron beam radiation are the same; 1) the mechanism by which living organisms are destroyed is the same, 2) both enjoy parametric release after processing, and 3) both utilize the same dosimetry and indicator systems. This point is supported by the fact that both technologies are governed by the same ISO standards when applied to medical device sterilization, ISO 11137 and ISO 13409. Both technologies have been proven effective at sterilization and are accepted world wide. APPLES n’ ORANGES: There are, however, significant differences between the two forms of sterilization radiation processing.
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4. IRRADIATION SERVICES
Radiation Tolerance Study (1-015-85) – Nutek sets up and delivers a specified dose to a sample of your packaged devices to determine the effect of irradiation on the materials and packaging. The resultant samples are analyzed by the client or test laboratories to determine the physical effects of radiation. This test is frequently paired with a Depth-Dose Penetration study to determine if there are adverse physical effects at the highest dose expected in routine irradiation. It may also be used to determine the effect of re-sterilization on a returned device, or to establish the upper limit for dose in a radiation-sensitive device.
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5. ROUTINE STERILIZATION VALIDATION WITH NUTEK
Choosing the Validation Method and Approving the Protocol The Client and NUTEK agree on a validation method that suits the production volume and expected contamination level of the device. Some large volume manufacturers use Method I of ISO 11137-2:2006, Sterilization of health care products-Radiation – part 2: Establishing Sterilization Dose but it requires a minimum of 140 samples. For smaller production, NUTEK recommends using Method VDmax from ISO 11137-2:2006, Sterilization of health care products – Radiation – part 2: Establishing Sterilization Dose. It can require as few as 27 samples and a dose of the product as it will be sterilized in production form. The manufacturer, NUTEK, or a 3rd party writes a customized experimental protocol for the device that carries out the following four steps:
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6. STERILIZATION OF MEDICAL DEVICES
This is a brief guide to sterilization validation for Medical Device Manufacturers who plan to use E-beam or Gamma Radiation to sterilize their product. FDA, ISO, and AAMI guidelines are now harmonized so a single strategy can ensure regulatory compliance with all applicable standards.
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7. SMARTEO™ ETHYLENE OXIDE STERILIZATION SERVICES
SmartEO™ Ethylene Oxide Sterilization is the only program in the industry that provides high-value ethylene oxide sterility solutions and an integrative approach for the entire product life cycle – from concept, design, and testing to packaging, validation, and high-volume production.  SmartEO™ integrates some of the lowest ethylene oxide prices in the industry… with high-end benefits… at no additional charge.

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8. E-BEAM VS. ETO STERILIZATION
I had just joined a small start-up company. My first major assignment was to validate the sterilization process for our products. Having completed several validations at other companies using E-beam, EtO, and Steam I was fully prepared for the task. Like any other small start-up, I was on a very tight schedule and budget and knew I had to get it right the first time! I had two totally different product lines to complete the sterilization validation on. One was a simple configuration consisting of “one product”, the second having a “family” line of products. I started by evaluating the materials that comprised each product line. Could they tolerate E-beam, would they pass EO residual requirements, could E-beam or EtO penetrate the product and packaging? I reviewed the short and long term forecast, of which was very minimal input for our new, innovative product and company. Where is the sterilization facility located? Could we afford a 2-3 week turnaround time for EtO sterilization once manufacturing was up and running or did we need (or want) the capability of sterilizing the product (using E-beam) in as little as 4 hours? What potential design changes may occur that would require justifying the validation is acceptable if a change were made?
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9. NUTEK TAILORED VALIDATION SERVICES
Nutek offers irradiation process verification that is matched to each specific client need. For routine sterilization of commodity products where the lowest dose and continuing cost is important, we follow the requirements of ISO 11137-1:2006, Sterilization of health care products –Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ISO 11137-2:2006, Sterilization of health care products-Radiation – part 2: Establishing Sterilization Dose, for validation method VDmax25. The complete validation requires somewhat higher initial testing costs but provides the most economical solution overall for commodity goods that have inherently low bioburdens. For more typical medical device production runs, we recommend the VDmax method that allows somewhat lower testing and verification costs but requires that the product can tolerate somewhat higher radiation doses and maintains a bioburden below 1000 CFU/item.
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10. WHY A VERIFICATION DOSE ENSURES STERILITY
All recognized technical standards for radiation sterilization recommend using a “verification dose experiment” rather than a product sterility test to verify sterility of a product. It isn’t immediately obvious, however, why taking a small number of product samples to perform a verification dose experiment is so much better than simply checking the final batch for sterility using about the same number of samples.
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