Good quality practices (and ISO 11137) dictate that the response of a medical device’s existing bioburden be checked during both initial process validation and periodically thereafter. Samples are irradiated at a dose that is a fraction of the production dose and the samples are then checked for sterility. A successful verification dose experiment therefore assures a safety factor in routine sterilization. NUTEK will deliver a dose within 10% of the target or within 0.5 kGy, whichever is larger, to comply with the current regulatory requirements.
One of our customers came to us with an E beam sterilization requirement for their product and suggested Nutek, a company that we didn't have any previous relationship with. In addition, this was our first product using this type of sterilization method and we needed a lot of technical guidance. I called Nutek and right from the first phone call they've been tremendous. They were able to make us feel comfortable about our project and quickly gave us a very comprehensive quote and a good understanding of the process, including help with protocols that saved us time. Excellent customer service is what we live by here at ProMed so I really appreciated the level of customer service from Nutek. Just this morning, our engineer that is working on this project walked into my office and said "boy are those guys good". A lot of times I wouldn't spend the time to give a testimonial, but because working with Nutek was so enjoyable, easy and much better than I ever expected, I am willing to go the extra mile.
President, ProMed Pharma
One of our customers came to us with an E beam sterilization......more
Nutek’s dosing system is outstanding. They put dosing sensors all over the box and also inside the box so I know what the dosages are everywhere. We make orthopedic devices that aren’t that dense, so the radiation gets through, but Nutek is so conscientious they even put sensors in the middle of the box. So, I have a good feeling that everything is being zapped and that all of the locations of every device are getting the same equal dose. I’ve been working with Nutek since the early 1990’s, way before our current start up. With this start up, they walked us through the validation process and helped us know what we’re looking at for FDA, ISO, and even helped us have a clear idea moving forward of the space we need for production. And not once has Nutek been off schedule. They deliver on time and if they say it’s done, it’s really done.
CEO, Aleeva Medical
Nutek’s dosing system is outstanding. They put dosing......more
Other contract sterilizers don’t have the controls in place that Nutek does and some lack on the regulatory side. Nutek has the right systems in place, as well as the ability, and desire, to do custom work that is critical in nature. I’m doing things with Nutek that I’ve never done before, with anyone. Nutek provides support, answers, and knowledge; they work with me and they know their field. Nutek is the best I’ve worked with. Nutek is my chosen partner for sterilization projects and I recommend them to all of my clients.
Dr. James Forsell
Dr. Forsell, a past President of the American Association of Tissue Banks, has broad-based experience in tissue and eye banking, as well as in organ procurement organizations. Having 30 years of experience, Dr. Forsell is well versed in the sterilization of tissues. He has published many scientific articles in peer reviewed journals and has authored works published in various books. Dr. Forsell consults to the transplant and tissue industry throughout the United States and internationally, including the sterilization of biologics and allograft tissues. He recommends sterilization solutions for...
Other contract sterilizers don’t have the controls......more
Nutek is a lot better than other contract sterilizers. We've worked with them on products, like drug filled stents on catheters. Nutek does extra things like helping with prototyping, working out test plans, and fine tuning packaging configurations... which makes design and validation a lot easier. Not only is Nutek reliable, efficient, and supportive, but they have great turnaround times, too. The bottom line is that Nutek helps us save time from design and validation all the way through to production.
Medical Devices Process Engineer
Nutek is a lot better than other contract sterilizers.......more
When we first started the sterilization part of our project, I was amazed at the personal attention and direct interaction we received directly from Larry Nichols, the Nutek CEO. Nutek satisfied their deliverables within the promised timeline with minimal interaction from us. They give great customer service while certifying sterility of product. I don’t worry about being an expert in sterilization because I trust Nutek to have it covered for me. I count on Nutek to be my sterilization partner.
Product Development Manager
When we first started the sterilization part of our......more
Nutek has shown itself to be reliable, flexible, and knowledgeable of E-beam sterilization. I’ve worked with numerous sterilizers and know the critical nature of sterility assurance levels, it’s reassuring to know that with Nutek’s knowledge and ability to work with certified laboratories to establish and monitor these critical parameters to maintain safe and sterile products. Nutek has a robust validation process and a thorough understanding of ISO 11137 standards. They’ve been informative with best approaches for compliance and routine monitoring.
Program Manager, Tautona Group
TauTona Group is a venture capital fund and incubator, and invests in projects across all medical specialties. As with any endeavor in the medical industry, costs, risks, and time to market are always important. Time is money. Therefore, TauTona moves forward very aggressively with timelines and cost. Tony Gipson, a program manager at TauTona, is responsible for the successful management of these programs and timelines from concept through commercialization, including testing, sterilization, and validation for production. Since Electron Beam (E-beam) irradiation provides quick-turn opportunities, leaves no harmful residuals and is an environmentally friendly technology, it is a preferred sterilization method.
Nutek has shown itself to be reliable, flexible, and......more
E-beam Sterilization: more materials, faster, and less cost than our competitors.DOWNLOAD NOW!
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