beforehandThe importance of controlling trace amounts of particulate matter in injectable drugs is describedThis article describes the microscopic detection method. Common Standards for Regulated Injectable DrugsUSP 788The standard stipulates that two methods can be used for inspection, one is the light-obscuring particle counting test and the other is the microscopic inspection method.
Among them, the microscopic detection method mainly focuses on the analysis of emulsions, gels, lipids and other liquids with higher viscosity or lower transparency, and there is a clear specification of the relevant standards and test methods.
Recognition of blank values
Particulate matter of injectable drugs can be categorized into internal and external sources. Intrinsic sources are mainly insoluble particles that exist in various types of preparations, while extrinsic sources may be insoluble particles or air bubbles caused by packaging or re-dissolution steps.
Therefore, at the outset, it is necessary to confirm that the ambient blank value is suitable for the test. Make sure that the environment, vessels and membranes are clean enough to ensure that the source of the detected particles is from the liquid to be tested.
TestingEvaluation of Results
A single package larger than 100 ml is considered a large volume parenteral, while a single package smaller than 100 ml is considered a small volume parenteral. Depending on whether a large volume parenteral or a small volume parenteral is being handled, the criteria for determining the labeling will be different.
| Number of ≥10 µm particles | ≥25 µm particle count | |
| Large Volume Parenteral | 12 per ml | 2 per ml |
| Small Volume Parenteral (SVP) | 3000 per container | 300 per container |
The USP 788 microscopy method is suitable for both large and small injectable doses, but there are specific requirements for the microscope specifications, such as sufficient magnification to ensure clear detection of 10µm particles; and because the USP 788 standard regulates the total number of particles, the choice of an automatic scanning counter is not an option.MicroscopeIt is also a good way to minimize the error of personnel operation.
In the medical field, the standards USP788 and USP789 for pharmaceuticals and ASTM F3127 and ASTM F2847 for medical devices are used to detect insoluble particles. If you are in need of testing equipment or services, please contact Yuanli Instruments for a complete solution to meet international standards.
Author:Cleanliness LaboratoryEngineer YEUNG Sing-hoi/EditorEditor: Yeung Nga Tong
