PDA TR 13

TR-13 serves as a resource applicable for controlled environments in general however its primary focus is environmental monitoring for sterile product manufacturing.

This document discusses international standards and regulatory guidances, elements of an EM program, and EM application. Current (at the time of publication) guidelines for typical EM levels and frequencies are presented in Section 3.0 and levels for pharmaceutical water are covered in Section 6.8.

A comprehensive environmental monitoring program should demonstrate the effectiveness of a solid CCS focusing on:
– Sound facility design, including barrier systems (e.g., isolators and RABS), operation and maintenance
– Established documentation systems
– Qualified sanitization, disinfection, and decontamination procedures
– Reliable process controls
– Good housekeeping practices
– Effective area access controls
– Consistent sample collection and analysis
– Effective training, certification or qualification, and personnel evaluation programs (e.g., periodic shop/manufacturing-floor oversight programs by a quality assurance unit and/or adequate subject matter experts)
– Quality assurance and control of materials, facilities, and equipment
– Continuous improvement and quality risk management programs

Bulk and intermediate product bioburden monitoring (except for pharmaceutical water) is not considered part of all EM programs and is therefore outside of the scope of this technical report. For more specifics on this topic, refer to PDA Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations (1).