Expanded on TR 27, aligning modern CCI testing with current regulatory expectations and risk-management principles.
It helps companies meet regulatory expectations for proving that their packaging prevents microbial ingress and maintains sterility. pda technical report 27 pdf
PDA Technical Report No. 27 establishes industry best practices for evaluating the integrity of primary packaging components used for sterile pharmaceutical products. Core Objectives Expanded on TR 27, aligning modern CCI testing