PDA Technical Reports (TRs) offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These resources are peer-reviewed, global consensus documents written by subject matter experts on issues relating to a wide array of challenging technical areas. PDA’s TR Library currently includes nearly 80 invaluable and influential reports. PDA Technical Report 13, Revised, (TR 13) Fundamentals of an Environmental Monitoring Program This TR serves as a resource on controlled environments test methods, focusing primarily on microbiological control for sterile product manufacturing. (Some nonviable particulate information is also included.) This second revision reflects substantial revision to regulatory guidelines, international standards, and scientific advances in environmental monitoring procedures and equipment. PDA Technical Report 22, (TR 22) Revised 2011, Process Simulation for Aseptically Filled Products This revised TR takes a thorough look at the aseptic processing technology, including the continuing changes that have occurred in within the global industry over the last 15 years. Contributions to this topic by organizations, regulators, compendia, and individuals in this area are considered. Guidance is offered regarding where risk-based approaches may be applied. PDA Technical Report 70 (TR 70), Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities The systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic- and bioburden-controlled manufacturing facilities and classified environments are identified in this TR. Focusing on controlled and non-controlled environments, microbial contamination control and corrective actions for loss of control for viable excursions contamination, this TR provides comprehensive information, suggested best practices, and appropriate references to support such guidance. PDA Technical Report 69 (TR 69), Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations This TR presents the current scientific understanding of the causes and control strategies for bioburden in pharmaceutical production systems, with a special emphasis on biofilms in fluid-handling systems. It encompasses pharmaceutical and biopharmaceutical manufacturing processes, but does not include the final aseptic and terminal sterilization fill-finish operations. PDA Technical Report 62 (TR 62), Recommended Practices for Manual Aseptic Processes Methods and approaches for control and evaluation of aseptic processing operations for drug/medicinal products that use all or partially manual procedures are outlined in this TR. It has value for hospital and formulation pharmacies where manual aseptic processing may occur, and may be applicable to the following select operations: vaccine preparation, cell culture, gene therapy, Investigational New Drug/IMP manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing. PDA Technical Report 74 (TR 74), Reprocessing of Biopharmaceuticals This TR provides guidance in the design, development, controls, procedures, validation, regulatory submission, and implementation of reprocessing procedures for biopharmaceutical manufacturing. It focuses on recombinant biopharmaceutical products, including proteins and polypeptides produced via recombinant and non-recombinant cell-culture expression systems. Two case studies are presented to illustrate how the general principles may be applied.