Technical Notes

Practical Annex 1 checklist for Australian sterile manufacturers covering CCS, aseptic processing, facilities, monitoring and remediation.

TAKEAWAY If you are building or refining your contamination control strategy, this report shows you how to structure a science- and risk-based CCS that connects facility, equipment, utilities, consumables, and monitoring into one coherent concept. ARTICLE AT A GLANCE PDA Technical Report No. 90 provides a practical framework for developing, implementing, and maintaining a holistic contamination control strategy across sterile manufacturing, from CCS foundations and risk asses

TAKEAWAY If you are working with single-use systems, this article shows you in concrete terms how to design a defensible, risk-based leak and integrity test strategy that actually protects your batches and uptime. ARTICLE AT A GLANCE Based on Hogreve et al. (2024) and Sartorius integrity science, you learn how to translate MALL, microbial ingress data, and validated physical test methods into a robust SUS concept rather than isolated tests. This gives you immediately usable a