The efficient planning of temperature-controlled storage for pharmaceutical products

corresponding

Achim Sponheimer
Miebach Consulting GmbH, Frankfurt am Main, Germany

Abstract

Unlike the planning of conventional warehouses, additional criteria must be considered for storage and material flow planning in pharmaceutical companies. All areas must be qualified from the very start of planning – including the areas of climate control, documentation of storage conditions (e.g. monitoring system), as well as entrance and access control, and particularly for material flow changes in the production area. The following article examines the success factors for efficient and successful warehouse planning in climate-controlled areas for the pharmaceutical industry.


TEMPERATURE-CONTROLLED STORAGE IN THE PHARMACEUTICAL INDUSTRY
In the pharmaceutical industry, products are associated with very high standards for temperature, storage conditions, clean-room-standards, or compliance with the stipulations of the Narcotics Act and these must be consistently upheld. Legal building codes may be a source of confusion at first glance in this respect, since medications, by definition, cannot be marked as toxic or hazardous in countries like Germany (since this would discourage the patient from taking them). As a result,if toxic or hazardous properties are presentthe requirements imposed must be fully complied with for both storage and transportation. Such requirements are especially relevant when it comes to the separation of inventory due to temperature requirements. It is forbidden to store some materials from various hazard classes, with various toxicity levels, and with other properties together, thus necessitating the establishment of different storage and fire compartments for each temperature range and group of products. The newly created subgroups can cause the minimum number of essential sto ...