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
**Who they are**
Andersen Scientific is an ISO 13485 certified provider specializing in Ethylene Oxide (EtO) sterilization and validation services for medical devices. They focus on supporting small to medium volume clients and R&D projects.
**Expertise & scope**
* Offers ISO 13485 certified Ethylene Oxide sterilization and validation.
* Provides sterilization for reusable medical devices requiring high-level disinfection or sterilization, including those with specific lumen dimensions.
* Conducts turnkey validation for devices intended for the human healthcare market, encompassing protocol development, study management, process challenge device establishment, bioburden testing, EO residual analysis, and final reporting.
* Performs "mini" validations for single lots, suitable for animal or human clinical studies, allowing devices to be labeled as sterile for the study duration.
* Services include creating custom sterilization agreements, assigning control numbers, examining packaging, and incorporating external process challenge devices (ePCDs) or biological indicators (BIs) into sterilization loads.
* Provides optional preconditioning at no charge.
* Delivers comprehensive sterilization records, including graphical printouts, summary data, biological and dosimetric results, and packaging of the sterilized load.
* Offers validation protocol development, detailing objectives, process descriptions, equipment, device specifications, loading configurations, bioburden analysis, resistance studies, and lethality demonstrations.
**Reputation / proof points**
* ISO 13485 certified.
Andersen Scientific is an ISO 13485 certified provider specializing in Ethylene Oxide (EtO) sterilization and validation services for medical devices. They focus on supporting small to medium volume clients and R&D projects.
**Expertise & scope**
* Offers ISO 13485 certified Ethylene Oxide sterilization and validation.
* Provides sterilization for reusable medical devices requiring high-level disinfection or sterilization, including those with specific lumen dimensions.
* Conducts turnkey validation for devices intended for the human healthcare market, encompassing protocol development, study management, process challenge device establishment, bioburden testing, EO residual analysis, and final reporting.
* Performs "mini" validations for single lots, suitable for animal or human clinical studies, allowing devices to be labeled as sterile for the study duration.
* Services include creating custom sterilization agreements, assigning control numbers, examining packaging, and incorporating external process challenge devices (ePCDs) or biological indicators (BIs) into sterilization loads.
* Provides optional preconditioning at no charge.
* Delivers comprehensive sterilization records, including graphical printouts, summary data, biological and dosimetric results, and packaging of the sterilized load.
* Offers validation protocol development, detailing objectives, process descriptions, equipment, device specifications, loading configurations, bioburden analysis, resistance studies, and lethality demonstrations.
**Reputation / proof points**
* ISO 13485 certified.
Additional information
Andersen Scientific's sterilization services are available seven days a week, with pricing starting at $350 per run, emphasizing transparency with no hidden fees. They handle the entire validation process for medical devices intended for the human healthcare market, which includes managing the study, establishing challenge devices, and coordinating various tests such as bioburden, EO residuals, and LAL testing. For R&D or clinical studies, they offer a "mini" validation for single lots, enabling devices to be labeled as sterile for the study's purpose. Their validation protocols are designed to provide documented evidence that a specific process consistently produces a product meeting predetermined specifications and quality attributes, referencing relevant standards and equipment qualification studies.
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 supporting small to medium volume clients and R&D.
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 "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... 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 and early-stage device development requiring sterilization.
How engagement typically works
- Turnkey validation services for market-ready devices.
- Single-lot validation for clinical studies.
Typical deliverables
- ISO 13485 certified sterilization cycles.
- Comprehensive validation reports and process specifications.
- Sterilization records including biological and dosimetric results.
- Custom sterilization agreements.
Good to know
- Best when requiring Ethylene Oxide (EtO) sterilization.
- Not intended for devices to be used on humans in a healthcare setting if not part of a formal validation process for sterile label claim.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: Starting at $350 per run
Notes:
Based on publicly listed information; final fees depend on scope and specific validation requirements.
“Sterilization fees start as low as $350 per run (with no hidden fees).”
HQ:
Research Triangle Park, US
Languages:
English
Timezones:
EST
Claim 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
Sample Return Policy:
Dispose
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 testing
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
<$10k
Pricing Model
Fixed package
