Quality & Compliance
Where We Stand
We’d rather be clear about our quality level upfront than have it come up as a surprise partway through your project.
Our Quality Approach
LyoVial’s quality processes are aligned with ISO 13485 principles. Our facility and processes are built for pilot-scale, R&D-oriented production.
Sterility Testing
Our lyophilization process has not been formally validated for sterility assurance. What we offer is batch-level testing: on request, a completed batch is sent to an independent, accredited third-party laboratory and tested for sterility. Results are shared with you directly, batch by batch.
What This Means for Your Project
LyoVial is well suited to research, feasibility, pilot, and early-stage production work. We are not a substitute for GMP-certified sterile manufacturing where that is a regulatory requirement for your product — for example, for Health Canada licensed drug products.
- Research Use Only (RUO) reagents and components
- Calibrators, controls, and media supplements for laboratory use
- Cosmetic actives and formulations
- Feasibility and pilot batches ahead of a GMP scale-up decision