Particulate contamination is often the first indication of a broader quality issue. While many particles are non-viable, some originate from microbial sources or are associated with microbial contamination events. Distinguishing between these possibilities is critical to determining appropriate corrective actions.
We approach particulate analysis as part of a broader contamination assessment, integrating physical characterization with microbiological context.
What We Support
We support evaluation of visible and subvisible particulate matter in pharmaceutical products, medical devices, and manufacturing environments, particularly in cases where the origin of the particles is unclear.
Compendial Particulate Testing
Particulate testing for injectable and ophthalmic products is governed by compendial methods that define both methodology and acceptance criteria.
USP <787> provides light obscuration-based testing for subvisible particulate matter in injections, while USP <790> defines requirements for visible particulate inspection.
These methods establish limits and procedures, but do not identify the nature or source of the particles. When results approach limits or visible particles are observed, further investigation is required.
Characterization and Microbiological Context
Microscopy and visual analysis provide initial characterization of particulate matter, including morphology and composition indicators. Where microbial involvement is suspected, particulate findings must be evaluated alongside microbiological data to determine whether viable contamination is present.
This integrated approach is essential during investigations, where particulate findings alone are not sufficient to establish root cause.
Program Design
Particulate evaluation is typically performed as part of a broader investigation or quality program. We support structured approaches that link particulate findings to microbial testing, environmental monitoring, and process data.
Standards and Regulatory Framework
Programs may align with:
- USP <787> Subvisible Particulate Matter in Injections
- USP <790> Visible Particulates in Injections
- USP microbiological methods where applicable
- FDA expectations for contamination control and investigation
Start the Conversation
If you are seeing unexplained particulate matter, we can help determine whether microbiology is part of the issue and support a structured investigation.
