Interventions Risk Evaluation and Management in Aseptic Manufacturing.

Interventions performed by personnel during an aseptic process can be a key source of microbiological contamination of sterile biopharmaceutical products, irrespective of the type of manufacturing system used. Understanding the relative risk of this source of contamination provides valuable information to help make decisions for the design, qualification, validation, operation, monitoring, and evaluation of the aseptic process. These decisions can be used to improve the aseptic process and provide assurance of the sterility of the products. To achieve these goals, an assessment of the contamination risk is needed. This risk assessment should be objective, accurate, and useful. This article presents an Intervention Risk Evaluation Model (IREM) philosophy and an objective, accurate, and useful method for intervention risk determination. The IREM uses a key word approach to identify, obtain, measure, and evaluate intervention risk factors. This article presents a general discussion of the method with the help of a case study to illustrate the development of the model, whereas subsequent parts would focus on application of this model with practical examples. This not only attempts to create objectivity of the entire process, but it develops awareness of the associated risks among shop floor operators, which can lead to a reduction of the overall risk level of the process and an improvement in the sterility assurance level.

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.

In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality.

In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used internationally for similar processes or applications. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated health care product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled health care products internationally. The glossary is expected to continue to evolve; and further industry, academic, and regulatory input is encouraged.