Annex 1 expects more than limits and SOPs.
It expects a Contamination Control Strategy (CCS) that is continuous, proactive, and based on real process understanding.

SizeID.bio provides exactly that.

We analyze large populations of particles and microbial structures across your entire process using Imaging AI and Raman AI, giving QA teams a clear, lifecycle-based view of what is happening — and why.

CCS Begins With Understanding the Whole Lifecycle

We support contamination control from beginning to end:

Raw Materials
Spot foreign matter and recurring patterns early, before they enter production.

Water Systems (PW, HPW, WFI)
Monitor both microbes and particulates together.
We reveal biofilm-related changes, corrosion, polymer residues, and other signals that don’t show up in simple counts.

Environmental Monitoring
Understand the source of excursions across cleanroom zones — distinguishing skin, fibers, equipment wear, packaging residues, or unexpected new patterns.

Production & In-Process Control
Detect drift, equipment wear, cleaning issues, or process-related shifts through particle trends.

Fill–Finish & Components
Understand contributions from silicone, rubber, polymers, glass, and steel.

Visual Inspection & Stability
Contextualize reject trends and long-term changes.

Every step feeds into a clearer CCS.