Pda Technical Report 82 -

PDA Technical Report 82: Low Endotoxin Recovery (LER)

Published by the Parenteral Drug Association (PDA), Technical Report 82 provides guidance on evaluating and qualifying cleaning processes and procedures for pharmaceutical and biotechnology manufacturing. The report aims to help companies establish effective cleaning validation protocols to ensure product safety and quality.

TR 82 explicitly states what regulators will ask during an inspection: pda technical report 82

Since its release, TR 82 has become a recognized standard by major health authorities, including the EMA. However, as of 2024–2025, there are ongoing industry efforts and PDA conferences focused on revising the report to address new data on the clinical relevance of LER and the effectiveness of different endotoxin types. Technical Report No. 82 "Low Endotoxin Recovery" PDA Technical Report 82: Low Endotoxin Recovery (LER)