Pharmaceutical Applications

Water Activity for ICH Q6B
Laboratory Compliance

Water activity (aw) is a critical quality attribute in pharmaceutical manufacturing. GBX 
analyzers provide the precision and compliance features required for regulated
environments, from R&D through to production QC.

ICH Q6B Compliance

Our instruments meet ICH Q6B guidelines for testing specifications of biotechnological/biological products, ensuring your lab stays audit-ready.

CFR21-PART11 Compliance

Our devices can be supplied with PC and embedded software compliant with CFR21-PART11 for FDA regulated environments.

Excipient & API Stability

Precisely measure water activity in active pharmaceutical ingredients and excipients to predict shelf-life and stability.

Scientific Rationale

Justify the absence of preservatives or microbial tests with solid Aw data, aligned with ICH Q6A and FDA CMC.

Ready to Ensure Compliance?

Contact us for a tailored solution that meets your pharmaceutical
quality requirements.