Biology Reference
In-Depth Information
Figure 11. Generic process flow from bulk to packaging operations.
that are used in multidose settings will contain an antibacterial agent to mini-
mize microbial growth after initial breech of the stopper septum. The bulk
rHuEPO product together with the excipients added to make up the formula-
tion is referred to as the formulated bulk.
The formulated bulk is sterile filtered into a holding vessel and stored there
until filled. Dosage-form components such as vials or syringes are filled using
automated equipment in a clean-room environment. The filled vials and
syringes are immediately stopper and capped (in the case of vials). Product
contact components such as stoppers, vials, and syringes used are washed and
depyrogenated at high temperature or sterilized in the presence of steam. Some
components can be purchased from vendors pre-sterilized and ready to use.
Each filled vial or syringe is inspected for particulate matter in solution or
cosmetic defects, such as marks or scratches. Additionally, each unit is inspect-
ed to ensure that proper lot number and expiration date have been applied to
the label.
