Routine Processing at NextBeam’s North Sioux City Facility
What Is “Routine Processing”?
Routine processing at NextBeam involves shipping any product already validated for processing at our facility for processing via the previously validated process.
How Do I Get Setup for Routine Processing?
Getting setup for routine processing at NextBeam is a straightforward process:
3 steps to routine processing
Obtain a NextBeam Processing Specification (PS)
A PS provides technical detail as to how NextBeam will process a defined product (or, in some cases, a family of defined products).
There are several paths to finalizing a NextBeam PS:
For products marketed as sterile:
Complete a sterilization validation process per the ISO 11137 standard. This process along with basic logistical details on pallet loading is all that is needed to create a PS.
For products not marketed as sterile:
The customer may choose to validate per the ISO standard, use some subset of it, or nothing at all (e.g. a surface dose).
The candidate product is (typically) dose mapped to set the carrier loading pattern and parameters used for routine processing. The goal is to find the best overlap between efficiency and processing the product within its min and max dose specifications. The outputs of dose mapping are a Test Report (TR) describing the configuration used, as well as a Process Specification (PS) with instructions for receiving product, required storage conditions, carrier loading configuration, beam parameters, and post-processing steps.
Execute a Processing Agreement
Our sales team works with customers to understand and deliver the service the customer needs: volumes, turn times, guarantees, etc – and formalize this along with pricing in a short, customer-friendly agreement.
Ship Routinely
Once the above two items are in place, we are ready to process in volume! Validation and contracting together can be completed in as little as 2-3 weeks, depending on the customer’s ability to supply test product and ability to provide information and complete documentation quickly.
Once I Am Setup, How Do I Request Routine Processing?
Step 1
Contact Customer Service via phone or email to specify product type(s), quantities, and verify desired dates of service are available.
Step 2
Schedule shipping with your carrier of choice
Step 4
Customer Service will advise when the shipment is ready for pickup. Our standard turn time is 5 days.
Routine Processing FAQs
NextBeam’s North Sioux City facility by the numbers:
- State-of-the-art 10MeV linear accelerator
- Horizontal beam orientation
- Fully integrated chain-driven live roller (CDLR) conveyance system boasts excellent process interrupt recovery capability (E.g. in the event of machine interruption for any reason, product is still successfully dosed within limits.)
- Minimum dose: no practical limit
- Maximum dose: no practical limit
- Logistics capabilities: 50,000 ft2 of high-bay warehouse, 8 fullsize loading docks, and a location less than 1 mile from I-29
Conveyance system details:
- Carrier-based conveyance: products ride on stainless steel / polyethylene carriers that are conveyed into the radiation shield, through the processing area, and out again.
- The beam is horizontal – a box or boxes stacked on the carrier will be scanned as shown below
- Max product dimensions for standard operations: 48” x 48” x 30” (some larger objects are possible; contact us for details). In general, products designed to “cube out” a standard North American (GMA) pallet fit well in our carrier system.
- Carrier modification via non-recurring engineering work is possible when this makes sense for certain projects.
When the product has a Process Specification (PS) approved by both the customer and NextBeam, and applicable business agreements are complete. Our Sales or Customer Service team will advise you when this is completed.
Once a product is released for production, any changes must be evaluated and approved before implementation. Some minor changes are possible without repeating testing and only require updates to change product codes in existing documentation. More significant or complex changes will usually require performing a new dose map. Contact lab@nextbeam.com to determine the impact of a product modification.
We provide a Certificate of Irradiation containing traceability information along with data on the dose delivered to the product.
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