Are your water systems ready for the changes to Annex 1? The new revisions on contamination control strategy requirements state water for injection (WFI) systems are a critical utility for manufacturing sterile pharmaceutical products. With this added emphasis, the water produced from these systems must comply with current monographs of the relevant pharmacopeia.

While WFI systems are typically a hostile environment for microorganisms, harmful biofilm-producing organisms could still survive and colonize, thus putting patient safety at risk. So, it’s critical to qualify, monitor, and maintain them regularly.

In this presentation you will learn:

• The enhanced requirements within the Annex 1 revision related to WFI as a critical excipient
• How routine monitoring of water systems for Gram-negative endotoxin can provide an early warning of adverse drift
• Rapid LAL cartridge technology and how it can be utilized early on to detect the presence of biofilm in a WFI system