Vial and Stopper Preparation

Vials must be thoroughly washed, dried, sterilized, and depyrogenated. They should be handled in a clean room to minimize contamination by particulate matter. Washing is normally done in automated vial washers using purified water, filtered oil-free air, and a final rinse of WFI. 

Rubber closures for vials are also washed and depyrogenated in an automatic washer. The final rinse of the stoppers should be WFI. The use of detergent is optional. These operations should occur in a clean room to minimize contamination. After washing, stoppers are batched and autoclaved prior to entering the sterile area. 

Depending on stoppering equipment and tendency of stoppers to clump during sterilization, a silicone lubricant may be added to the stoppers prior to sterilization. Several manufacturers offer equipment which is capable of all these operations-washing, silicone addition, and sterilization. 

Vial and stopper washers are available that will allow processing from the clean room area into the sterile area in one operation. This equipment eliminates the transfer of vials and stoppers into the sterile area through ovens or autoclaves, thereby minimizing the potential for viable or nonviable particulate contamination. A typical flow sheet for the handling of vials, stoppers, and miscellaneous equipment is shown in Fig. 4. 

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