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On-Demand Webinars

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LVP polyolefin solutions addressing different packaging and regulatory requirements

LVP can be packed in different packaging formats made from polyolefins: pouches, bottles produced in blow-fill-seal process or Injection stretch...

Video: An introduction to large volume parenterals (LVPs) as a pharmaceutical dosage form and an E&L challenge

Pharmaceutical dosage forms are differentiated primarily by their route of administration and secondarily by other dosing parameters. Parenteral dosage forms...

Primary and Secondary Packaging Materials as potential source of Nitrosamines: impact on E&L Study design

Recently there have been a number of drug product recalls due to the unexpected presence of N-Nitrosamines. While in most...

Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices

When Drug Products were submitted for approval, Regulatory authorities ask the question, “Are you submitting your Risk Assessment for the...

The Big Three: Cytotoxicity, Sensitization & Irritation Testing

Of all the tests manufacturers need to be prepared to conduct on their medical devices, none are more important than...