Clean utilities are ubiquitous in biopharma manufacturing – particularly in aseptic manufacturing areas. Clean utilities are any utilities that are required to meet specific quality requirements to ensure they can be safely used in manufacturing. Typical clean utilities found in biopharma facilities are:
- Purified Water (PW)
- Water for Injection (WFI)
- Clean Steam
- Clean Compressed Air
- Process Gases (e.g., nitrogen, oxygen)
Clean utilities are high-risk systems, as they are usually direct product contact or indirect product contact. Therefore, they must be carefully designed to ensure utility quality and product quality requirements are consistently met. Well controlled clean utilities are critical for regulatory compliance.
Typical issues that Kymanox sees with clean utilities are:
- Improperly sized generation systems.
- Insufficient system documentation (e.g., weld documentation, material test reports, pressure test reports, isometric drawings).
- Unknown or not scientifically-based specifications for utility purity/quality.
- Over and under specifying materials of construction for distribution systems.
- Improper distribution system design (e.g., piping slope, air vents, steam traps, dead-legs, etc.).
Kymanox has helped many biopharmaceutical manufacturers specify their utility systems. We specialize in sizing utility generation systems. Properly sized systems provide the necessary utility quality while minimizing operational costs. Kymanox has also assisted clients with commissioning and qualification of their clean utilities. A well-designed and maintained utility system will reliably support manufacturing processes for years to come.