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| home > white papers > Systems Engineering for Complex Portable Medical Device Development - Phillips-Medisize |
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 WHITE PAPERS |
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Phillips-Medisize
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Systems Engineering for Complex Portable Medical Device Development
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As the demand for complex, portable medical devices continues to grow,
reducing risk and increasing efficiency during the development of these
products should be paramount. Taking a systems-engineering (SE) approach
to development provides a holistic, organized, and deliberate method
for identifying as well as reducing both patient and business risks
early in the process. Furthermore, it facilitates efficient progression
throughout the entire product development life cycle.
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News and Press Releases |
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3P Biopharmaceuticals and Nordic Nanovector have extended partnership for Betalutin® late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment
The non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events |
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CPhI & P-MEC India
26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India
As the pharma industry looks increasingly towards India for high quality,
low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies
wanting to pick up on the latest trends and innovations the market has to
offer. At CPhI & P-MEC India, you will meet the movers and shakers from
India's pharma machinery, technology and ingredients industries, giving you a
competitive advantage that will help grow your business.
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