PDA TR 70

PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified environments. Focusing on controlled and non-controlled environments, microbial contamination control and corrective actions for loss of control for viable excursions contamination, this technical report provides comprehensive information and suggested best practices as well as appropriate references to support such guidance. This document is not intended to fully address product-contact surface cleaning from a clean in place or clean out of place system, which is specifically addressed in PDA Technical Report No. 29: Points to Consider for Cleaning Validation and PDA Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation.