USP 797 and Inhalation Products

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Lukas Westendorf
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USP 797 and Inhalation Products

I am curious how other sites are interpreting this or have found other guidance. We use the Aerogen syringes for some of our continuous inhalation products and they currently are not manufactured as sterile and we have not identified a sterile, safe substitute.

1.1
Scope
1.1.1 CSPs affected:
• Aqueous preparations for pulmonary inhalation.

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