Below you'll find a list of all posts that have been categorized as “Industry Updates”
An Introduction to Leachables and USP <1664> Leachables are chemical entities that migrate from one material matrix into another. In pharmaceutical development, leachables typically refers to chemicals from packaging or delivery systems which migrate into a drug product under normal storage conditions, potentially impacting the safety or efficacy of the …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
By now you are probably aware of the changes made to USP <661> in 2016 and the addition of USP <661.1> and USP <661.2> this year. In short, these changes required more in-depth analytical investigations on plastic packaging and materials. They also demonstrate how the USP is leading the charge …
