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Pharmaceutical Manufacturing and Packing Sourcer


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News and Press Releases

Turkish Cargo includes Sheremetyevo Airport near Moscow to its cargo flights network.

As the fastest growing brand among the global air cargo carriers with its extensive flights network, Turkish Cargo included Sheremetyevo Airport (SVO), known as being the most important airport in Russia in terms of cargo activities, to its direct cargo flight destinations network.
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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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Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDAs Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the worlds largest conference on this subject
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