A comprehensive User Requirements Specification (URS) acts as the backbone of your cleanroom design. It articulates the specific needs and expectations of your operation, ensuring that your chosen cleanroom solution effectively meets these requirements. A robust URS should meticulously consider aspects such as: * The scope of the processes taking
Confirming Cleanroom Suitability Through Robust Design Qualification (DQ)
Robust design qualification (DQ) is a essential step in establishing the suitability of a cleanroom for its intended use. This rigorous process involves a systematic analysis of the cleanroom's design to ensure it meets all necessary requirements and standards. DQ steps typically comprise reviews of engineering drawings, simulations, and risk asses