USP <788> Particulate Matter Injections
Ensuring patient safety is paramount in the pharmaceutical industry, and managing subvisible particulates is a critical aspect of this commitment. Subvisible particulates, though tiny, can significantly impact patient health, potentially causing adverse reactions like inflammation or immune responses, and even compromising the efficacy of the drug. Consequently, it’s essential for drug manufacturers to conduct thorough subvisible particulate testing to confirm the safety of their products for patient use.
Ensuring Injection Safety with USP 788
Subvisible particulate testing is an important aspect of drug development and manufacturing. These tests are designed to detect and quantify particles in pharmaceutical formulations that are too small to be seen with the naked eye, but could still cause harm. Subvisible particulate testing typically involves using specialized instruments and techniques like light obscuration, light microscopy and micro-flow imaging. By testing for subvisible particulates, manufacturers can ensure that their products meet regulatory requirements and are safe for patient use. These tests can also help identify potential issues with manufacturing processes or formulation, allowing manufacturers to make necessary adjustments and improve their products.
Defining Excellence in Injectable Drug Safety
USP 788 is a widely recognized standard for testing particulate matter in injections. It provides guidelines for testing the amount of particles in injections to ensure they meet certain safety standards. The standard outlines various tests and acceptance criteria for particulate matter in injections, including limit tests, light obscuration tests, and microscopic particle counting. These tests help ensure that injections are safe and effective for patients.
Ensuring Injection Safety with USP 788
Subvisible particulate testing is an important aspect of drug development and manufacturing. These tests are designed to detect and quantify particles in pharmaceutical formulations that are too small to be seen with the naked eye, but could still cause harm. Subvisible particulate testing typically involves using specialized instruments and techniques like light obscuration, light microscopy and micro-flow imaging. By testing for subvisible particulates, manufacturers can ensure that their products meet regulatory requirements and are safe for patient use. These tests can also help identify potential issues with manufacturing processes or formulation, allowing manufacturers to make necessary adjustments and improve their products.
Early-Phase Development
Container Closure
Integrity Testing
Particulate
Analysis
Medical Device
Analysis
Extractables
& Leachables
For comprehensive subvisible particulate testing services, turn to Gateway Analytical. Our advanced testing capabilities and expertise ensure that your pharmaceutical products meet the highest standards of safety and quality.