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SmartEO™ Ethylene Oxide Brochure Subscribe to our Newsletter About Us

SmartEO™ Ethylene Oxide Brochure

SmartEO™ is the only program in the industry that provides high-value ethylene oxide sterility solutions and an integrative approach for the entire product lifecycle – from concept, design, and testing to packaging, validation, and…

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About Us

NUTEK Corporation is an FDA-registered sterilization facility that provides reliable Electron Beam and Ethylene Oxide services for healthcare products and medical devices. All services meet, or exceed, ISO 13485, 11137, 11135, and SLA requirements.

NUTEK’s unique system design ensures precise dose control with no over or under dosing of …

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Welcome to Nutek!

Nutek provides Electron Beam and Ethylene Oxide irradiation and sterilization services.

Our philosophy is very simple:  Provide the highest standards in the industry – from R&D and testing, to dose mapping and validation, through production and beyond.  All of Nutek’s E-beam and EtO sterilization services meet, or exceed, all ISO 13485, 11137 & 11135 standards, SLA Requirements, and our strict QA and QC ISO compliant processes… period.  So, whether you need high-volume, on-demand, or custom services for R&D, testing, validation or production, we make sure your high standards are met using our high standards… every step of the way.

SmartDose™ ELECTRON BEAM STERILIZATION - Sterilizes materials and combination devices that others can’t at prices they charge for basic processing.  Use it for R&D, testing, high-volume or low-volume production – saves time, saves money, and best of all… helps get your products to market quicker.*
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SmartEO™ ETHYLENE OXIDE STERILIZATION – includes the quickest standard turnaround and all the bells and whistles at a price the competitors charge just for basic processing.*
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STERILIZATION VALIDATION – Choosing your validation method and approving the protocol: mapping, bioburden, verification, and evaluation.
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RADIATION TOLERANCE STUDY – Determines the effect of irradiation on materials and packaging.  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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DEPTH-DOSE PENETRATION STUDY – Uses multiple dosimeters to monitor high-low density areas of a speci­fic product/package configuration for routine irradiation and allows a surface dose speci­fication in order to deliver the minimum dose throughout the product/package.
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PRODUCT DOSE MAPPING – Determines optimum packaging to minimize variability and processing costs, recommends a target surface dose and process limits, and provides a three dimensional map of the dose received throughout the product/package during irradiation.
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VERIFICATION DOSE AUDIT – Verifies existing bioburden.Samples are irradiated at a dose that is a fraction of the production dose and the samples are then checked for sterility. Successful dose audits provide a safety factor.
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VERIFICATION DOSE DISTRIBUTION STUDY – Maps the maximum and minimum doses delivered to the product in a single layer and optimizes the verification dose.
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PRE-QUALIFIED PACKAGING PROGRAM – Nutek has created a unique service with pre-qualified packaging options for its e-beam irradiation processing, which allows you to know your materials are sterile but time is the limiting factor.
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NUTEK TAILORED VALIDATION SERVICES – Irradiation process verification that is matched to each specific client need. Under certain circumstances, we recommend modification of the ISO and AAMI standards using our pre-verified packaging methods and completion of the verification activities at lowest cost.All methods meet requirements based on the intended use of the product, while providing the benefit of balancing time, cost, and required documentation for each unique situation.
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CROSSLINKING & SCISSIONING – Using irradiation to strengthen and/or enhance material qualities.
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CONSULTING – Consulting and turnkey sterilization validation programs for each client’s special need. We work with all major microbiological testing laboratories and can help you choose the best validation program to meet your requirements. From on-site seminars and turnkey validation programs to friendly technical advice, our technical services team provides an extraordinarily broad array of service for each client.
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MICROBIOLOGICAL TESTING – Includes bioburden determination, verification dose calculation and irradiation, and sterility testing to verify that the resident bioburden meets the requirements of the standard.
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 *SmartDose™ and SmartEO™ include the following at no additional charge:

 1.  Fastest standard turnaround in the industry for all R&D, batch, and routine production:  48-hours for E-beam; 72-hours for Ethylene Oxide; our standard turnaround beats the industry average of up to one week. We also offer several expedite options.

2.  Prices that are among the lowest in the industry, even with premium services included.  Our 100% customer-driven culture and operationally efficient business model allows us to offer this level of exceptional value to our customers.   

3.  Use of our R&D Innovation Center – utilize our E-beam and EO sandbox in Silicon Valley to design, test, and innovate to help ensure your products give you a competitive advantage.

4.  Ability to schedule our sterilization experts to help with R&D, compliance, design, test, packaging, protocols, validation, and production.

5.  Ability to utilize any of Nutek’s proprietary optimization methods specifically for your products to reduce costly product re-designs, save money, and get your product to market faster.          

6.  Protection and elimination of sterility risks for your entire product life cycle from concept through production; receive turnkey sterilization and validation to ensure you meet – or exceed – all ISO 11137, ISO 11135, and SAL protocol requirements… guaranteed.

7. TRUST – don’t believe us, believe our customers:

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Nutek Corporation… Sterilization By Design