Identifying & Mitigating Errors in Organic Extractables & Leachables Screening

Previously Aired on June 17th, 2020

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The discipline of Organic Chromatographic “Screening” to discover, identify and (semi-)quantify organic compounds in an extract (from a pharmaceutical container closure system or from a medical device) or in a drug product is a relatively new concept to both the Pharmaceutical and Medical Device Industries.

Typically, a combination of chromatographic techniques is used to cover a broad range of organic compounds with a wide variety of physicochemical properties and chemical functionalities. A combination of Headspace G/MS (Volatile Organic Compounds), GC/MS (Semi-Volatile Organic Compounds) and LC/MS (Non-Volatile Organic Compounds) is applied in Screening processes. While the Chromatographic Screening process is the best solution to cover the three functions is should serve (discovery, identification and quantification), each function of the screening process is prone to errors that are inherent to the screening methodology.

In this webinar you’ll learn:

• The risk of omission: omitting a compound in chromatographic screening is a fatal error, as the assessment of the extractables or leachables profile is irreversibly compromised by committing the error

• The risk of inexact identification: if the wrong identity for a compound is secured, then clearly the substance’s impact on the devices suitability cannot be assessed as the link between the extractable and its relevant toxicological information cannot be established.

• The risk of inaccurate and imprecise quantitation in chromatographic screening processes.

The presentation will explain these errors in detail and will address the issue on what can be done to minimize the occurrence of these errors or how to mitigate their impact on the final screening outcome.

Who should attend:

• Manufacturing/Processing  • Clinical

• Clinical Research                       • QA/QC

• Regulatory                              • Compliance

• Drug Safety                            • Engineering

• Packaging                                • Drug Delivery

• R&D                                            • Validation

• Supply Chain


Piet Christiaens, PhD
Scientific Director
Nelson Labs Europe
View Biography
Mike Auerbach
American Pharmaceutical Review