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Understanding the Evolution of USP 661 and Pharmaceutical Plastics Testing

This post is a shortened version of a longer article available on our website. Why Test Pharmaceutical Plastics? The United States Pharmacopoeia (USP) has set analytical standards to ensure polymer materials do not impact human health regardless of how or when those materials come in contact with a pharmaceutical product. Plastics …

Nitrosamine structures

Nitrosamine Impurity Guidance

In February 2021, the FDA released a guidance document “Control of Nitrosamine Impurities in Human Drugs” with a stated goal of emphasizing the importance of reducing and mitigating nitrosamine impurities in APIs and drug products. The guidance discusses nitrosamine formation and the “vulnerable” processes and materials that may produce nitrosamine …

An Introduction to the Analytical Evaluation Threshold

What is an Analytical Evaluation Threshold (AET)? An important concept in extractables and leachables analysis, and specifically in medical device chemical characterization, is the analytical evaluation threshold or AET. AET is defined by the International Organization for Standards (ISO) as “a threshold below which the analyst need not identify or quantify leachables …

BPOG Extractables and Leachables

Are your BPOG protocols up to date?

What is a BPOG protocol? The BioPhorum Operations Group (BPOG) is a collection of companies encompassing approximately 80% of the global commercial biopharmaceutical capacity. Collectively, in 2014, they published “Best Practices Guide for Evaluating Leachables Risk from Polymeric Single-Use Systems Used in Biopharmaceutical Manufacturing” and “Standardized Extractables Testing Protocol for …

Biocompatibility for Medical Devices and Combination Products

The Updated ISO 10993-18

In January 2020, the International Organization for Standardization (ISO) released their updated guidance ISO 10993 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process. This update provides ongoing clarity into worldwide expectations for medical device biocompatibility assessment, though the document is still a …

Biocompatibility for Medical Devices and Combination Products

An Overview of ISO 10993 and Biocompatibility

What is Biocompatibility? According to the FDA, biocompatibility “is the ability of a device material to perform with an appropriate host response in a specific situation” (Source: FDA Use of International Standard ISO-10993-1). Put more simply, this means the materials (or their degradants, leachables, or residuals) that make up a …

USP and - The ABCs of E&L

USP 1663 and 1664 – The ABCs of E&L

Two crucial USP chapters include USP <1663> “Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems” and USP <1664> “Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems”. These chapters are for informational purposes, but discuss practical and technical aspects for assessing extractable/leachable risk and designing appropriate experiments to monitor …

Organic Impurities

USP 476 – Expanding Regulations on Organic Impurities

In January 2018, the United States Pharmacopeia (USP) finished receiving comments on proposed chapter <476> Control of Organic Impurities in Drug Substances and Drug Products. This chapter was developed as a part of the USP’s periodic review identifying gaps in current standards. There are several USP chapters that already provide …

BPOG Extractables and Leachables

BPOG and the USP – Mitigating Leachable Risk in Biopharmaceutical Manufacturing

Single-Use Systems (SUS) in Biopharmaceutical Manufacturing Smaller batch sizes and ambient processing conditions have led to a rapid increase in single-use systems (SUS) and SUS components in biopharmaceutical manufacturing. These systems often improve cost effectiveness, operating efficiency, and the environmental sustainability of processes. However, as many of these components are …