Undergoing tests is a critical step in the process of transforming an innovative design into a reliable and marketable product

BIOLOGICAL, PHYSICAL AND CHEMICAL TESTING

Our Commitment to Quality

At Nubeno Healthcare, we pride ourselves on delivering the highest quality products to our customers. Our state-of-the-art Product Testing Laboratory is the cornerstone of our commitment to excellence, ensuring that every product meets the rigorous standards of safety, efficacy, and reliability that our customers expect.

  • Cutting-Edge Technology: Our laboratory is equipped with the latest technology and advanced instrumentation, allowing us to conduct comprehensive testing and analysis. From chemical /Physical & performance to microbiological safety, our facilities are designed to handle a wide range of testing requirements.
  • Experienced Professionals: Our team of experienced analyst and technicians brings a wealth of knowledge and expertise to our testing processes. Their dedication to accuracy and precision ensures that every product is thoroughly evaluated and meets all regulatory and industry standards.

 

  • Commitment to Compliance: Nubeno Healthcare adheres to stringent regulatory requirements and industry best practices. Our laboratory operations comply with international standards, including ISO, GMP, and FDA guidelines. This commitment to compliance ensures that our products not only meet but exceed the expectations of our customers and regulatory bodies.
  • Innovation and Continuous Improvement: We are dedicated to continuous improvement and innovation. Our laboratory constantly evaluates and implements new methodologies and technologies to enhance our testing capabilities. This proactive approach allows us to stay ahead of industry trends and provide our customers with the most reliable and advanced products available.
  • Sustainable Practices: At Nubeno Healthcare, we are committed to sustainability and environmental responsibility. Our laboratory practices are designed to minimize environmental impact through efficient use of resources, waste reduction, and adherence to eco-friendly protocols.

Physical evaluations generally involve tests for the physical strength of a device (such as tensile strength and elongation) and physical performance characteristics (including force at break and resistance to leakage), as well as tests for product shelf-life.

Biological evaluations address a device’s bio-compatibility, and can also include biological performance tests such as resistance to bacteriophage, impermeability to microorganisms and bacterial filtration efficiency.

The chemical analysis of a medical device generally includes a wide range of tests and product evaluations. Testing can include tests for chemical compositions as well as tests to determine the potential for extractable or leachable materials or residues that are not intended to be part of the chemical composition but are present as a result of manufacturing processes. Additional chemical tests can include performance requirements, such as resistance to corrosion, permeation rates for chemicals, and anticipated shelf-life studies.

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