Decoding Warehouse – Chapter 2: Risk Assessment of De-Dusting Tunnel
This chapter focuses on systematic risk assessment of the de-dusting tunnel used in pharmaceutical warehouses for cleaning and de-dusting shipper cartons, drums, and containers before they enter controlled areas. It explains why this step is critical for preventing particulate, microbial, and cross-contamination risks at the warehouse–production interface.
Using practical pharma examples, the chapter walks through:
- Typical hazards in de-dusting tunnels (design gaps, poor air flow, inadequate cleaning, operator errors)
- Application of 6M / Ishikawa, FMEA, and risk matrix tools to identify and evaluate risks
- Linkage with GMP, GDP, and data integrity expectations for material entry control
- How to define risk control measures – engineering controls, SOPs, qualifications, and monitoring
- Sample risk register format and how to document justifications for residual risk
By the end of this chapter, readers will understand how to convert a de-dusting tunnel from a basic utility into a validated GMP control point with clear risk ownership, documented evidence, and sustainable compliance. This is a ready-to-use guide for QA, warehouse, production, and validation teams looking to strengthen their material entry process.