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Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
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News and Press Releases

Leading pharma packaging companies commit to supply for Covid-19 fight

The CEOs of Gerresheimer, Stevanato Group, and SCHOTT are committed to ensuring ample supply of pharmaceutical containers for any Covid-19 vaccine and treatment that is developed, and that no patient shall be left behind, no matter what region of the world they live in. Also, the companies will make every effort to support the pharma industry’s’ priorities for overall medication supply in addition to Covid-19 drugs. Each of the three companies manufactures billions of type-1 borosilicate glass vials, the most proven and most widely available material used to store and deliver vaccines around the world. They are making the statement to provide confidence in the global pharmaceutical supply chain in times of uncertainty.
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White Papers

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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