A Line To Support Your Biologics
We present our most advanced capability in drug product filling lines for late phase and commercial products.
Our drug product filling line is housed in an isolator located in a Grace C Cleanroom with Denesting and Filling Areas under a Grade A Cleanroom and Annex 1 compliant.
Gloved robotic isolators for late-phase clinical and commercial batches up to 150,000 units per batch.
DP line includes real-time viable environmental monitoring (EM) with contamination control strategies, no glass-to-glass contact, 100% fully automated inspection, electronic batch records, and pre-use post-sterilization integrity testing (PUPSIT). Line built to fulfill EU GMP Annex 1 standards.
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