5blzlsxcqdifip9e2zbo aps

APS Biocompatibility Testing

Minneapolis, Minnesota, US

American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you benefit from:

  • A Team of professionals that understand the clinically indicated use of medical devices and assist in defining the appropriate biocompatibility testing required for your device and developing any necessary custom techniques to allow for reliable testing of even the more complex medical devices.
  • A variety of custom extractions to meet your device needs.
  • A focus on minimizing the number of devices used through extraction and test assay planning.
  • Biocompatibility testing according to ISO, USP, and JMHLW guidelines.
  • USDA-registered facilities that are accredited by ISO 17025 and the American Association for the... Show more »

American Preclinical Services offers a full biocompatibility testing program. Here at APS, we take the time to understand the specifics of your medical devices and we take a clinically relevant approach to designing and implementing your panel of biocompatibility assays. At APS you benefit from:

  • A Team of professionals that understand the clinically indicated use of medical devices and assist in defining the appropriate biocompatibility testing required for your device and developing any necessary custom techniques to allow for reliable testing of even the more complex medical devices.
  • A variety of custom extractions to meet your device needs.
  • A focus on minimizing the number of devices used through extraction and test assay planning.
  • Biocompatibility testing according to ISO, USP, and JMHLW guidelines.
  • USDA-registered facilities that are accredited by ISO 17025 and the American Association for the Accreditation of Laboratory Animal Care (AAALAC).

Standard & Custom Protocols

APS offers both standard (ISO10993, USP <87>, USP <88> & JMHLW) and custom biocompatibility testing protocols for material and component evaluations, in-vivo and in-vitro testing.

« Show less

APS Biocompatibility Testing has not listed any services.

Lot Release Testing
Price on request
Request a quote for more information about this service.
Drug Release Studies/In Vitro Release Testing (IVRT)
Price on request
Request a quote for more information about this service.
Biocompatibility Testing
Price on request

In-vivo Testing

APS offers an array of in-vivo testing. We have both large and small animal capabilities with numerous study designs that can be used for biocompatibility evaluations. Let our experienced staff help you select or design the right in-vivo tests to meet all of your requirements.

Sensitization Testing

-... Show more »

In-vivo Testing

APS offers an array of in-vivo testing. We have both large and small animal capabilities with numerous study designs that can be used for biocompatibility evaluations. Let our experienced staff help you select or design the right in-vivo tests to meet all of your requirements.

Sensitization Testing

  • Guinea Pig Maximization
  • Buehler
  • Murine Local Lymph Node Assay (LLNA)

Irritation Testing

  • Intracutaneous Reactivity*
  • Vaginal Mucosal Irritation
  • Systemic Toxicity Testing
  • Materials Mediated Pyrogenicity
  • Acute Systemic Toxicity
  • Sub-acute Toxicity
  • Sub-chronic Toxicity
  • Chronic Toxicity

Implantation Testing

  • Subcutaneous Implant
  • Intramuscular Implant

In-Vivo Thrombogenicity Testing

  • Canine, Porcine, Ovine, Bovine
  • 4hr, 72hrs
  • Standard and Custom Designs

Not all in-vivo thrombogenicity studies are created equal.

As the designs of medical devices continue to become more advanced, the overall placement of the device challenges traditional methods. Currently, devices subject to a standard thrombogenicity test are typically placed into the jugular vein with minimal concern as to the impact of blood flow, fit or placement. In reality the traditional design lacks the ability to ensure a proper placement of a device and it is not possible to confirm that proper blood flow has been maintained prior to starting the four-hour indwelling period.

The in-vivo thrombogenicity studies are especially challenging tests for many labs to conduct, given the required equipment, in-house technical expertise and implantation methodologies needed. APS offers you these services, plus superior surgical and interventional deployment techniques using fluoroscopy, which makes the test more reliable and reproducible.

In-vitro Testing

American Preclinical Services has a broad range of in-vitro testing services. We offer multiple methodologies that can be used for the evaluation of biocompatibility, toxicology and lot-release testing. Depending on your regulatory requirements, our in-vitro services offer tests that meet ISO 10993, USP <87>, and JMHLW guidelines.
We are passionate about offering alternative methods that can be used for the evaluation of your product. If you have a specific test methodology that may not be in our current scope, please contact us today to discuss availability and/or a validation plan to meet all of your testing needs.

Cytotoxicity Testing

  • Agar Overlay
  • Direct Contact
  • MEM Elution
  • Neutral Red Uptake
  • MTT
  • Limulus Amebocyte Lysate (LAL)

Hemocompatibility Testing

  • Hemolysis (ASTM, USP and JMHLW)
  • Complement Activation C3a and SC5b Assay
  • Partial Thromboplastin Time (PTT)
  • Prothrombin Time Assay (PT)
  • Platelet and Leukocyte
  • In-vitro Blood Loop

Genotoxicity Testing

  • AMES (Bacterial Mutagenicity)
  • Chromosome Aberration
  • Mouse Lymphoma Assay
  • Mouse Micronucleus Assay (Peripheral Blood Method)
« Show less
Medical Devices & Diagnostics
Price on request
Request a quote for more information about this service.
Formulation Services
Price on request

Formulation & Manufacturing Services

Formulation & Manufacturing Services

« Show less

APS Biocompatibility Testing has not received any ratings.

Be the first to endorse APS Biocompatibility Testing

Endorse this lab