SCALE, CAPABILITIES, AND CONTAINMENT
PharmTech: Can you explain how the Freiburg and Illertissen facilities complement each other in terms of scale and capabilities?
Weyhers: The Illertissen site focuses on HC manufacturing and specialized packaging operations; the facility can handle compound classes, including highly active compounds, cytotoxics, and hormones. Our three containment suites accommodate a portfolio of medium- to large-volume products, with batch sizes of 80–700 kg. Containment facilities are highly automated, and follow the "engineered containment" philosophy (i.e., a best-in-class environmental health and safety approach in line with current regulatory requirements). The processes in the NEWCON facility and our smaller scale ICON facility are fully automated and remotely controlled, thus there is no contact whatsoever between operator and product.
The Illertissen facility received ISPE's 2008 "Facility of the Year Award" for process innovation and garnered the overall ISPE 2008 "Facility of the Year Award." The facility's innovative "cell concept" layout (in contrast to the more traditional modular design) and the automated remotely run production processes previously described incorporate the current aspects of process visualization, manufacturing execution systems, process visualization, masterbatch recording, and electronic batch recording.
CONTAINMENT AND SUSTAINABILITY
PharmTech: Can you describe the containment approach at the Freiburg facility and its sustainability features?
Schuemmelfeder: DevCon has been designed as a multiple module facility to provide best flexibility during product development ranging from 1 to 150 kg. Our PPD group, and its facilities are an integral part of Pfizer's manufacturing site in Freiburg, which received the ISPE 2011 Facility of the year Award for Sustainability. The design of the Freiburg facility incorporates a range of eco-friendly technologies, such as geothermal energy for cooling and heating, adiabatic cooling , and other sustainable building design elements (photovoltaics, energy monitoring, and performance windows, for example.) We also introduced greener laboratory techniques. Subsequently, we have achieved notable improvements in HVAC (heating, ventilation, air conditioning) energy consumption levels. As a result, we are now generating some 93% of total plant energy from renewable energy technologies.