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 services for medical devices, including those requiring a sterile label claim for the human healthcare market.
* Conducts turnkey validations which encompass protocol development, study management, process challenge device establishment, bioburden testing, EO residual analysis, and final report generation.
* Offers a "mini" validation for single lots, suitable for animal or human clinical studies, allowing devices to be labeled as sterile for the specific lot processed.
* Supports sterilization for reusable medical devices requiring high-level disinfection or sterilization, with qualified cycles for devices with specific lumen dimensions.
* Provides sterilization for devices not intended for human use in healthcare settings, such as for labs, researchers, animal studies, or DNA-free requirements.
**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 services for medical devices, including those requiring a sterile label claim for the human healthcare market.
* Conducts turnkey validations which encompass protocol development, study management, process challenge device establishment, bioburden testing, EO residual analysis, and final report generation.
* Offers a "mini" validation for single lots, suitable for animal or human clinical studies, allowing devices to be labeled as sterile for the specific lot processed.
* Supports sterilization for reusable medical devices requiring high-level disinfection or sterilization, with qualified cycles for devices with specific lumen dimensions.
* Provides sterilization for devices not intended for human use in healthcare settings, such as for labs, researchers, animal studies, or DNA-free requirements.
**Reputation / proof points**
* ISO 13485 certified.
Additional information
Andersen Scientific's sterilization services are priced starting at $350 per run, with no hidden fees. Their process includes creating custom sterilization agreements, assigning unique control numbers, examining packaging, placing challenge devices or biological indicators, optional preconditioning, providing comprehensive sterilization records, and packaging the sterilized load. They also offer a "turnkey validation" for devices requiring a sterile label claim, which includes managing all aspects of the validation study from protocol to final report. For clinical studies, a "mini validation" for a single lot is available to permit sterile labeling for that specific batch.
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.
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.
Source
“A “mini” validation for a single lot of devices is usually used for animal or human clinical studies”
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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 provider.
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 new medical device sterilization processes.
- Companies requiring ISO 13485 certified sterilization and validation.
How engagement typically works
- Project-based sterilization runs.
- Comprehensive turnkey validation studies.
- Single-lot validation for clinical trials.
Typical deliverables
- Sterilization records and graphical printouts.
- Biological and Dosimetric results.
- Validation protocols and final reports.
- EO residual testing reports.
- Process specifications.
Good to know
- Best when a sterile label claim is needed for the human healthcare market or for specific clinical studies.
- Suitable for devices with specific lumen dimensions for reusable device sterilization.
- Not intended for devices to be used on humans in a healthcare setting if only a basic sterile device is needed without a 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
