Andersen Scientific
Andersen Scientific, Inc.
Andersen Scientific offers ISO 13485 certified Ethylene Oxide sterilization and validation services for medical devices, specializing in small to medium volume clients and R&D support.
Andersen Scientific provides specialized Ethylene Oxide (EO) sterilization and validation services for medical device companies, with a particular focus on supporting start-up and small to medium-sized businesses. As an ISO 13485 certified facility, they are registered with the FDA and are committed to high standards of quality and customer service, aiming to be the go-to professionals for Ethylene Oxide sterilization needs. They position themselves as an extension of their clients' research and development teams, working closely with regulatory personnel to facilitate market entry. Andersen Scientific is recognized for its environmentally friendly processes, having received awards for reducing EO emissions and an EO permit exemption from North Carolina. Their services include turnkey validation for devices requiring a sterile label claim, mini-validations for clinical studies, and standard sterilization cycles. They offer flexible options, including 24-hour turnaround times and custom sterilization agreements, ensuring efficient, professional, and cost-effective solutions. Their validation services encompass establishing documented evidence that a specific process consistently produces a product meeting predetermined specifications. This includes detailed protocols covering objectives, process and equipment descriptions, device and packaging details, loading configurations, bioburden analysis, resistance studies, and multiple test cycles to ensure process capability and sterility assurance. They also provide comprehensive reporting and quality control checks.
About
**Andersen Scientific** provides ISO 13485 certified Ethylene Oxide (EtO) sterilization and validation services, focusing on medical devices. They cater to small to medium volume clients and offer support for R&D projects.
**Expertise & Scope**
* Offers ISO 13485 certified Ethylene Oxide (EtO) sterilization and validation services.
* Specializes in sterilization for reusable medical devices requiring high-level disinfection or sterilization, including those with specific lumen dimensions.
* Provides turnkey validation services for devices intended for the human healthcare market, encompassing protocol development, study management, process challenge device coordination, bioburden testing, EO residual analysis, and final reporting.
* Offers a "mini" validation for single lots, suitable for animal or human clinical studies, allowing devices to be labeled as sterile for the study duration.
* Supports sterilization for labs, researchers, animal studies, and DNA-free requirements where a sterile label claim is not required.
* Validation protocols include detailed process descriptions, device and packaging information, bioburden estimation, resistance studies, and cycle lethality demonstrations.
**Reputation / Proof Points**
* ISO 13485 certified.
**Expertise & Scope**
* Offers ISO 13485 certified Ethylene Oxide (EtO) sterilization and validation services.
* Specializes in sterilization for reusable medical devices requiring high-level disinfection or sterilization, including those with specific lumen dimensions.
* Provides turnkey validation services for devices intended for the human healthcare market, encompassing protocol development, study management, process challenge device coordination, bioburden testing, EO residual analysis, and final reporting.
* Offers a "mini" validation for single lots, suitable for animal or human clinical studies, allowing devices to be labeled as sterile for the study duration.
* Supports sterilization for labs, researchers, animal studies, and DNA-free requirements where a sterile label claim is not required.
* Validation protocols include detailed process descriptions, device and packaging information, bioburden estimation, resistance studies, and cycle lethality demonstrations.
**Reputation / Proof Points**
* ISO 13485 certified.
Additional information
Andersen Scientific's sterilization services are priced starting at $350 per run, with no hidden fees. They offer a range of included services such as creating custom agreements, assigning unique control numbers, examining packaging, placing challenge devices, optional preconditioning, providing detailed sterilization records, and packaging the sterilized load. Shipping costs are limited to the courier's quoted rate or client's own account. For validation, their process involves establishing documented evidence to ensure a specific process consistently produces a product meeting predetermined specifications. This includes developing a protocol with objectives, process and equipment descriptions, device and packaging details, bioburden analysis, resistance studies, and multiple cycle validations.
Key Highlights
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ISO 13485 certified Ethylene Oxide sterilization and validation services.
Source
“Andersen Scientific offers ISO 13485 certified Ethylene Oxide sterilization and validation services for medical devices”
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Specializes in small to medium volume clients and R&D support.
Source
“specializing in small to medium volume clients and R&D support.”
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Offers turnkey validation for devices requiring a sterile label claim in the human healthcare market.
Source
“For devices requiring a sterile label claim used in the human healthcare market. We will perform a turnkey validation”
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Provides a 'mini' validation for single lots for clinical studies, allowing devices to be labeled as sterile.
Source
“A “mini” validation for a single lot of devices is usually used for animal or human clinical studies where the device is still in its evaluation phase of development. The small lot release allows devices to be labeled as sterile.”
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Sterilization fees start as low as $350 per run with no hidden fees.
Source
“Sterilization fees start as low as $350 per run (with no hidden fees).”
Certifications & Trust Signals
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ISO 13485 certified.
Source
“Andersen Scientific offers ISO 13485 certified Ethylene Oxide sterilization and validation services”
Buyer Snapshot
Best for
- Small to medium volume medical device sterilization needs.
- R&D support for sterilization and validation.
- Companies requiring ISO 13485 certified EtO sterilization.
How engagement typically works
- Turnkey validation services.
- Custom sterilization agreements.
- Support for clinical study device processing.
Typical deliverables
- Sterilization validation reports.
- Sterile label claim for clinical studies.
- Sterilization records and graphical data.
- EO residual testing reports.
Good to know
- Best when a sterile label claim is needed for clinical studies or the human healthcare market.
- Not intended for devices to be used on humans in a healthcare setting if only a basic cycle is used without full validation.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: Starting at $350 per run
Notes:
Based on publicly listed information; final fees depend on scope.
“Sterilization fees start as low as $350 per run (with no hidden fees).”
HQ:
Research Triangle Park, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Sterilization + Microbiology Validation
Industries:
Medical Devices
Pricing model:
Custom pricing
Sterilization Methods Supported:
EtO (Ethylene Oxide)
Validation Types Offered:
Full validation (IQ/OQ/PQ), Other
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL)
Standards Supported:
ISO 11135 (EtO), ISO 11737-1 (Bioburden), ISO 11737-2 (Sterility)
Is Accredited:
Yes
Accreditation Body:
FDA
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Nda Support:
Yes
Minimum Project Size:
<$10k
Additional sterilization_microbiology_testing Details
Sterilization Methods Supported
EtO (Ethylene Oxide)
Validation Types Offered
Full validation (IQ/OQ/PQ), Revalidation, Single-lot-release studies
Microbiology Tests Offered
Bioburden, Sterility, Bacterial Endotoxin (LAL), EO residual
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Return
Minimum Project Size
Custom
Pricing Model
Per project
