Cleanroom qualification is a complex mission where the greatest challenges are not always microbial. In large-scale qualification projects, risks often arise from limited resources, lack of skilled personnel, or escalating costs. This presentation highlights pitfalls beyond regulatory threshold exceedances and illustrates how staffing and budget issues can significantly impact project success. Using practical examples, the talk will compare the benefits and drawbacks of executing projects with in-house teams versus complete outsourcing to service providers. The aim is to provide decision-makers with valuable insights into strategic project planning and effective risk management – ensuring that the “Mission Cleanroom” can be accomplished successfully.