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.

We have having challenges with keeping out hazardous cleanroom suite within the narrow 0.01-0.03 negative pressure range requirements. We do not have a pharmacy-dedicated air handler.