To assure patient safety, biologics developers and manufacturers must carefully consider where contaminants could be introduced to the drug substances (DSs) or drug products (DPs) at all stages of the ...
Purpose: Using a multiple-step testing medium-risk-level compounding test procedure, the evaluation of two work-practice changes to determine if the changes could effectively reduce the potential for ...
Why is aseptic processing important in pharmaceutical manufacturing? The manufacturing of both sterile drugs and biological products can be achieved through terminal sterilization or aseptic ...
Advancing Aseptic Precision: How Modern Filling Lines Elevate Sterility, Flexibility, and Throughput
Isolator-based Grade A/ISO 5 architectures minimize operator interventions, enabling robust contamination control and compliance with EU GMP Annex 1, FDA guidance, PIC/S, and ISO 14644. Lyophilization ...
This article outlines improvements and changes to non‐viable particle monitoring (NVP), sometimes referred to as total particulate monitoring, which during aseptic processing, is a regulatory ...
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