Contamination Control Strategy Evidence — Not Just Counts

From particle limits to source attribution across the full sterile lifecycle (EU Annex 1 and US GMP expectations).

We Give You the Data to Control

EU Annex 1 and US sterile manufacturing expectations increasingly require a living Contamination Control Strategy (CCS) | continuous, risk-based, and backed by evidence that explains what is happening and why.

SizeID.bio provides that evidence. We analyze large particle populations and microbial structures across your process using deep-learning imaging for targeting and Raman-based identification with integrated spectral algorithms for discrimination. So QA and manufacturing teams can link excursions to sources, mechanisms, and CAPA.

CCS Begins With Understanding the Whole Lifecycle

Identify foreign matter and recurring patterns early—before they enter production. Support supplier qualification, incoming inspection, and risk-based controls.
Monitor microbes and particulates together. Reveal biofilm-related shifts, corrosion signatures, polymer residues, and other contributors that simple counts can miss.
Explain excursions across cleanroom zones by differentiating typical contributors (skin, fibers, equipment wear, packaging residues) and highlighting emerging patterns.
Detect drift, equipment wear, cleaning issues, and process-related shifts through particle population changes and material attribution.
Quantify contributions from silicone, rubber, polymers, glass, and steel—supporting component risk assessments and investigation narratives.
Contextualize reject trends and long-term changes by tying "what is seen" to "what it is," enabling targeted remediation and comparability arguments.