Stopper Washer

Figure 4. Sterile vial preparation

11.2 Filling of Vials

Vials used in a filling operation are fed into the system automatically by a conveyor from a vial sterilizer or manually from trays that have been processed through a batch oven. Because of the increased risk of contamination, the former method is preferred.

Powder fills are made by aseptically transferring the sterile bulk powder from its containers into the hopper of the 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.1141

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.

Freeze dried vials are usually partially stoppered just before entering the dryer. Closures are seated into the vials mechanically at the end of the drying cycle. A typical freeze drying flow diagram is shown in Fig. 6.

Figure 6. Sterile freeze drying operation

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