ETO Sterilization-Plant #2
ETO Sterilization-Plant #2 offers specialized sterilization and microbiology testing services, leveraging EPA resources for environmental compliance and safety.
ETO Sterilization-Plant #2 is a provider focused on sterilization and microbiology testing, aligning with the 'sterilization_microbiology_testing' directory. While specific operational details are not provided, the provider's engagement with EPA resources suggests a commitment to environmental standards and regulatory compliance. The EPA website offers extensive information on environmental topics, laws and regulations, and contact points for inquiries, which can be valuable for understanding and adhering to industry best practices. This includes resources on chemical safety, waste management, and air quality, all crucial for sterilization facilities. The EPA's commitment to public health and environmental protection, as highlighted on their official .gov website, underscores the importance of rigorous testing and sterilization protocols. For further information on EPA regulations and services, their 'Contact EPA' page and 'About EPA' sections provide valuable insights into the agency's mission and operational framework.
About
**Who they are**
ETO Sterilization-Plant #2 provides specialized sterilization and microbiology testing services. They focus on leveraging electron beam (E-Beam) technology for product safety and material enhancement.
**Expertise & scope**
* Electron beam (E-Beam) sterilization for minimizing contamination and maximizing product safety.
* Processing volumes ranging from a fraction of a pallet to multiple full truckloads.
* Material compatibility testing to assess performance benefits and potential outcomes within two weeks.
* Services include E-Beam Process Overview, Validation + Dose Mapping, Routine Processing, and Crosslinking.
* Support for industries including Medical Device and Food & Consumer.
**Reputation / proof points**
* ISO 13485, 9001, and 11137-compliant quality standards.
* Track record of sterilizing over 5 million pounds of product since inception.
ETO Sterilization-Plant #2 provides specialized sterilization and microbiology testing services. They focus on leveraging electron beam (E-Beam) technology for product safety and material enhancement.
**Expertise & scope**
* Electron beam (E-Beam) sterilization for minimizing contamination and maximizing product safety.
* Processing volumes ranging from a fraction of a pallet to multiple full truckloads.
* Material compatibility testing to assess performance benefits and potential outcomes within two weeks.
* Services include E-Beam Process Overview, Validation + Dose Mapping, Routine Processing, and Crosslinking.
* Support for industries including Medical Device and Food & Consumer.
**Reputation / proof points**
* ISO 13485, 9001, and 11137-compliant quality standards.
* Track record of sterilizing over 5 million pounds of product since inception.
Additional information
NextBeam's E-Beam sterilization process is designed for efficiency and sustainability. They offer a rapid assessment of material compatibility, providing analysis and recommendations within two weeks of receiving a product sample. This allows clients to quickly understand if E-Beam technology is suitable for their materials and potential outcomes. Their services extend to validation and routine processing, supporting a range of product volumes. Clients can expect a focus on enhancing material performance, durability, and functionality.
Key Highlights
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Offers rapid material compatibility assessment within 2 weeks.
Source
“Know if E-Beam will work on your product within 2 weeks.”
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Processes product volumes from a fraction of a pallet to multiple truckloads.
Source
“We process volumes ranging from a fraction of a pallet to multiple full truckloads of product.”
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Operates under ISO 13485, 9001, and 11137-compliant quality standards.
Source
“Quality: ISO 13485, 9001, and 11137-compliant”
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Has sterilized over 5 million pounds of product since inception.
Source
“Track Record: 5 million+ pounds of product sterilized since inception”
Certifications & Trust Signals
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Adheres to ISO 13485, 9001, and 11137 quality standards.
Source
“Quality: ISO 13485, 9001, and 11137-compliant”
Buyer Snapshot
Best for
- Companies seeking E-Beam sterilization services
- Product manufacturers requiring material compatibility testing
- Businesses needing validation and routine processing for sterilization
How engagement typically works
- Sample-based material assessment
- Process validation and routine services
- Direct expert consultation
Typical deliverables
- Material compatibility analysis
- E-Beam process validation reports
- Routine E-Beam sterilization processing
- Crosslinking services
Good to know
- Best when material compatibility with E-Beam is a primary concern.
- Suitable for clients needing to process varying product volumes.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Industries:
Medical Devices
Sterilization Methods Supported:
EtO (Ethylene Oxide)
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ), Revalidation
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11135 (EtO), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
E-Beam
Validation Types Offered
Validation + Dose Mapping, Routine Processing
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Pricing Model
Per project
