Sterile drugs are crucial as treatments for patients with compromised immune systems. However, the manufacture of sterile drugs demands extraordinary attention to detail, not only in terms of equipment and processes, but in the design of the cleanroom itself. A sterile fill-and-finish cleanroom must provide all of the following features:
- Intensive pre-sanitization of all equipment and tools to be used in the cleanroom, via an autoclave or a hot-air tunnel.
- Tools and machine parts kept within arm’s reach in easy-to-access areas, so staff always know exactly where to look.
- Minimal distance between the lyophilizer and stoppering equipment, to prevent inadvertent contamination prior to stoppering.
- Semi-automated filling by mono-block or high-speed line, ideally inside or directly adjacent to the lyophilization chamber.
- Layout that facilitates smooth flow of personnel and sterilized components in one single direction, from the most sterile area toward the least.
- Mandatory visual inspections of filled batches to check for cloudiness, breakage, or any other evidence of contamination.
Sterile fill-and-finish is an intricate process. At VxP, we know exactly how to handle it.
