Injectable Drug Sterilization: Key Challenges and Strategies
Expert insights on terminal sterilization, sterile filtration, aseptic processing and Annex 1 compliance.
Nathan Meehan, Process Engineer at Lifecore Injectables CDMO, highlights sterilization strategies in injectable manufacturing, including challenges, changing regulatory expectations and isolator technology.
Nathan Meehan, Process Engineer at Lifecore Injectables CDMO, highlights sterilization strategies in injectable manufacturing, including challenges, changing regulatory expectations and isolator technology.
Choosing a Sterilization Strategy
Terminal sterilization, sterile filtration and aseptic processing each suit different products depending on heat sensitivity, viscosity and container type.
Evolving Regulatory Expectations
Annex 1 places greater emphasis on contamination control strategy, risk management and barrier technologies.
Future Trends
Isolators, closed systems and automation are reducing human intervention and improving sterility assurance.
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