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.
About This White Paper
This white paper is published by Lifecore Injectables CDMO and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.