Design Approaches to the Global QC Lab

Wednesday, September 20, 4:45 - 5:45 PM

Speaker(s): Sandro Orlandini

This session will present the procedure to design a Quality Control (QC) Lab--according to the current international regulations—and will discuss different processes and products typology. Lab projects will be presented that underline the points of strength and technical solutions as well as layout choices. The technical solutions for the critical utilities will be described and evaluated.

The presentation will describe the approach to the QC Labs design followed by CTP System. The main steps through which a QC Lab is designed are the following:

• URS Definition and Sharing, such as physical and environment needs, utilities, equipment and materials to support the measures and activities in testing a sample; the space needed to conduct a test, as well as space for the orderly placement and storage of equipment and materials; benches and floor materials that are compatible with their intended use, cleanliness and maintenance; and mechanical, electrical and plumbing needs to deliver the appropriate air changes, lighting and power, along with temperature and humidity control

• Design Development

• Design Review based on Risk Assessment Tools

• Commissioning, Qualification & Validation Planning according to the Company QS