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Pharmaceutical requirements
Absence of pyrogens
Pyrogen control
• Raw water should be appropriately treated to render it free from
pyrogens, such as water-for-injection (WFI) and used for
compounding the product or rinsing product contact surfaces such as
tubing, mixing vessels, and rubber closures.
65
Pharmaceutical requirements
Absence of pyrogens
Pyrogen control
• Rubber stoppers must undergo washing, thorough rinsing with WFI,
prompt sterilization, and protective storage to ensure adequate
pyrogen control.
• Plastic containers and devices must be protected from pyrogenic
contamination during manufacture and storage.
66 33
Salma E. EL-Habashy
