Standard Test for PDA TR13 Environmental Monitoring Program Fundamentals (Single User Digital Version)

EUROLAB laboratory provides testing and compliance services within the scope of PDA TR13 standard. This revision of TR 13 is in line with current industry trends and regulatory expectations and provides additional guidance and focuses on increasing expectations regarding data management and data integrity, qualification and maintenance of controlled environments, and rapid microbiological methods (RMM).

This white paper will help establish a robust, meaningful and practical environmental monitoring program while embracing innovation and quality risk management principles.

Also included are updates to microbiological and total airborne particle control concepts and principles relevant to facilities and other designated cleanroom environments involved in the manufacture of sterile pharmaceutical products.

While this TR can serve as a valid resource for controlled environments in general, its primary focus is environmental monitoring for sterile product production.

EUROLAB assists manufacturers with PDA TR13 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.