Sterile formulation 625 processed through a batch oven. Because of the increased risk of contami- tion, the former method is preferred Powder fills are made by aseptically transferring the sterile bulk powder from its containers into the hopper ofthe filling machine. Thetransfer is usually done from a container that is mechanically positioned over the hopper with a solid aseptic connection to the hopper The type of filling machine to be used is best determined from trial runs of various supplier machines. All filling lines and equipment should be designed to prevent contamination by people and particulate matter. A typical vial filling operation is shown in Fig. 5. More recent designs barrier technology to accomplish this objective. 4) NONSTERILE STERILE AREA STERILE AREA AREA ACCUMULATOR FCONVEYOR CAPPER <FILLER INSERTER SWING AWAY CON VEYOR Once a vial has been filled with powder, it is stoppered and transported out of the sterile area, and is capped The current regulatory trend is to perform the capping operation in a sterile area using sterilized caps. After capping, vials are usually visually inspected, labeled, and packaged A liquid fill operation is delivered to a pump through lines that have been sterilized in place or sterilized and assembled asepticallySterile Formulation 625 processed through a batch oven. Because of the increased risk of contami￾nation, the former method is preferred. Powder fills are made by aseptically transferring the sterile bulk powder from its containers into the hopper ofthe filling machine. The transfer is usually done from a container that is mechanically positioned over the hopper with a solid aseptic connection to the hopper. The type of filling machine to be used is best determined from trial runs of various supplier machines. All filling lines and equipment should be designed to prevent contamination by people and particulate matter. A typical vial filling operation is shown in Fig. 5. More recent designs incorporate barrier technology to accomplish this objective.[l41 NO NSTER 1 LE STERILE AREA STE w ILE - AREA ARElP Figure 5. Sterile filling line Once a vial has been filled with powder, it is stoppered and transported out of the sterile area, and is capped. The current regulatory trend is to perform the capping operation in a sterile area using sterilized caps. After capping, vials are usually visually inspected, labeled, and packaged. A liquid fill operation is delivered to a pump through lines that have been sterilized in place or sterilized and assembled aseptically