Sterigenics Expands with New X-Ray Facility
Exciting News in Sterilization
Here at Quantum EBX, we're always excited to see advancements and growth in the sterilization industry. That's why the recent announcement from Sterigenics about their new X-ray sterilization facility in Haw River, North Carolina, caught our eye.
This development, expected to be operational in late 2025, is great news for medical device manufacturers, pharmaceutical companies, and other industries in the Southeast US. The new X-ray facility will be located next to their existing gamma facility, expanding their capabilities and helping to meet the increasing demand for sterilization services in the region.
Why is it important?
X-ray sterilization is a powerful and effective method for ensuring product safety. It's particularly well-suited for a variety of products, including:
- Medical devices
- Pharmaceuticals
- Biopharmaceutical single-use-systems
- Commercial applications
Sterigenics highlights that their new facility will feature innovative technology designed for high-throughput processing and flexibility, accommodating a wide range of product configurations.
The Quantum EBX Advantage
While we congratulate Sterigenics on their expansion, it's also a good time to remember the specialized expertise Quantum EBX offers in the realm of e-beam and X-ray sterilization. As a consulting company, we focus on providing comprehensive services to ensure your sterilization processes are efficient, compliant, and tailored to your specific needs.
Whether you are considering X-ray sterilization for the first time, or looking to optimize your existing processes, Quantum EBX can help. Our services include:
- QMS Design & Implementation:
We develop robust Quality Management Systems that meet stringent FDA QSR and ISO 13485 requirements. This includes creating quality manuals, procedure development (SOPs), work instructions, and establishing document control.
- Product Validation:
Quantum EBX can guide you through the entire product validation process for e-beam and X-ray sterilization. This critical step involves defining product and packaging specifications, bioburden determination, dose mapping, and determining minimum sterilization and maximum allowable doses.
- Dosimetry System Services: Precise dose measurement is key to effective sterilization. We help with dosimetry system selection, implementation, qualification, and procedure development. We also offer calibration services and can assess your current dosimetry system for accuracy and reliability.
- Regulatory Compliance & Auditing:
Navigating the regulatory landscape can be complex. To help you through, we provide gap analyses, support for internal audit programs, and assistance with certification processes.
The expansion of X-ray sterilization capacity is a positive trend for the industry, offering more options and flexibility for manufacturers. At Quantum EBX, we're here to help you leverage these technologies effectively and ensure your products meet the highest standards of safety and quality.
Thinking about e-beam or X-ray sterilization for your products?
Contact Quantum EBX today
to learn how our expert consulting services can benefit your business!
