ABSTRACT
This chapter covers good design practices for packaging and warehousing facilities. It discusses the principles that are applied to packaging and warehousing facilities and addresses the critical function of a packaging facility to prevent product mix-ups and cross-contamination. It covers the steps needed to construct a new facility or renovate an existing one, and it describes the function and purpose of packaging and warehousing pharmaceutical product, the multiple levels of packaging areas, critical parameters, and utility system criteria. Chapter 11 specifically addresses sterile packaging, which will not be discussed here. The same hygienic zoning principles (i.e., white, gray, black, transition, and proper gowning techniques) that apply to pharmaceutical processing also apply to pharmaceutical packaging (see Chapter 15 for a description of hygienic zoning principles).
