Identify the application first
VanTsteri’s source commentary discusses VHP in medical-device sterilization, pharmaceutical environments and isolator applications. These contexts involve different intended uses and should not be treated as one interchangeable regulatory framework.
Define the evidence package
The commentary addresses process parameters, biological challenges, material compatibility, residual control and ongoing monitoring. A project needs a documented interpretation of the requirements that actually apply to its equipment, process and market.
Check primary requirements
This is a company-authored regulatory discussion, not a certificate of compliance or a statement that every VHP room-treatment system meets device-sterilization requirements. Specific chapter references and numerical limits should be confirmed against authoritative current texts before being used as acceptance criteria.