NextBeam
NextBeam offers reliable, efficient, and sustainable electron beam sterilization services. They specialize in validating sterilization processes to ensure product safety and compliance with industry standards like ISO 11137.
NextBeam provides precise and reliable contract electron beam sterilization services, minimizing contamination and maximizing product safety. They process a wide range of volumes, from partial pallets to full truckloads. Their expertise extends to sterilization validation, ensuring that your sterilization methods, such as e-beam, gamma, or X-ray radiation, consistently achieve the required Sterility Assurance Level (SAL). This process involves rigorous testing, controls, and documentation to prove the effectiveness of your sterilization. NextBeam guides clients through establishing the minimum dose (Dmin), maximum dose (Dmax), and dose uniformity ratio (DUR) critical for production viability. They support various industries including Medical Device, Food & Consumer, and Pharma & Bio. NextBeam's facility is built to meet stringent medical device standards, including ISO 11137, ISO 13485, and 21 CFR Part 820, offering rapid turnaround times for product qualification, often within 5 business days.
About
**Who they are**
NextBeam offers electron beam sterilization services, focusing on reliability, efficiency, and sustainability. They specialize in validating sterilization processes to ensure product safety and compliance.
**Expertise & scope**
* Electron beam (E-Beam) sterilization for various product volumes, from partial pallets to full truckloads.
* Validation and dose mapping services.
* Routine processing.
* Crosslinking applications.
* Material compatibility testing to assess E-Beam suitability within two weeks.
* Support for customers using radiation for medical devices and food & consumer products.
**Reputation / proof points**
* ISO 13485, 9001, and 11137-compliant.
* Sterilized over 5 million pounds of product since inception.
NextBeam offers electron beam sterilization services, focusing on reliability, efficiency, and sustainability. They specialize in validating sterilization processes to ensure product safety and compliance.
**Expertise & scope**
* Electron beam (E-Beam) sterilization for various product volumes, from partial pallets to full truckloads.
* Validation and dose mapping services.
* Routine processing.
* Crosslinking applications.
* Material compatibility testing to assess E-Beam suitability within two weeks.
* Support for customers using radiation for medical devices and food & consumer products.
**Reputation / proof points**
* ISO 13485, 9001, and 11137-compliant.
* Sterilized over 5 million pounds of product since inception.
Additional information
NextBeam provides a streamlined process for determining E-Beam suitability. By sending a small product sample, clients can receive an analysis of material compatibility, potential performance benefits, and outcomes within two weeks. This allows for informed decisions before committing to larger validation or processing runs. Their services are designed to enhance material performance, durability, and functionality, offering a competitive edge. They process a wide range of product volumes, accommodating needs from small batches to large shipments.
Key Highlights
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Offers electron beam sterilization services.
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“Minimize contamination and maximize product safety with reliable, efficient, and sustainable electron beam sterilization.”
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Specializes in validation and dose mapping.
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“Validation + Dose Mapping”
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Provides material compatibility testing within 2 weeks.
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“Know if E-Beam will work on your product within 2 weeks.”
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Compliant with ISO 13485, 9001, and 11137 standards.
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“ISO 13485, 9001, and 11137-compliant.”
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Has sterilized over 5 million pounds of product.
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“Track Record: 5 million+ pounds of product sterilized since inception”
Certifications & Trust Signals
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Operates under ISO 13485, 9001, and 11137 compliance.
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“ISO 13485, 9001, and 11137-compliant.”
Buyer Snapshot
Best for
- Companies seeking efficient and sustainable sterilization solutions.
- Manufacturers requiring validation and routine processing of medical devices and consumer goods.
- Businesses needing to assess material compatibility with E-Beam technology.
How engagement typically works
- Consultative approach for material compatibility testing.
- Process-oriented for validation and routine sterilization.
- Responsive communication for expert guidance.
Typical deliverables
- E-Beam sterilization processing.
- Sterilization validation and dose mapping reports.
- Material compatibility assessment reports.
- Crosslinking services.
Good to know
- Best when material compatibility is confirmed or can be assessed.
- Suitable for products that can withstand electron beam irradiation.
HQ:
North Sioux City, US
Languages:
English
Timezones:
CST
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Countries:
United States, Asia
Industries:
Medical Devices
Sterilization Methods Supported:
E-Beam
Validation Types Offered:
Full validation (IQ/OQ/PQ), Revalidation, Other
Standards Supported:
ISO 11137 (Radiation)
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
No
Lead Time Band:
Start in 0-2 weeks
Rush Available:
Yes
Sample Requirements:
Send us a small sample of your product, and we’ll examine material compatibility, performance benefits, and potential outcomes and provide you with summary analysis and recommendations for next steps as applicable.
Nda Support:
No
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
E-Beam
Validation Types Offered
Validation + Dose Mapping
Microbiology Tests Offered
Sterility
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
