Cooram operates Grade A cleanrooms with continuous environmental monitoring, delivering fully traceable sterile fill-finish operations aligned with FDA and EMA standards.
Grade A Operations
Environmental Control Protocols
Our sterile manufacturing facility employs continuous particle counting and pressure differentials to maintain absolute atmospheric integrity during liquid filling.
Continuous Particle Counting
Real-time sensors monitor viable and non-viable particulates down to 0.5 microns, ensuring unbroken compliance throughout clinical and commercial batch runs.
Traceable Batch Validation
Every vial is backed by fully digitized batch-level traceability, providing quality assurance directors with immediate access to environmental logs.
