Barrier/Isolater Technology for FDA Regulated Facilites
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Who Should Attend
Microbiologists, process engineers, manufacturing staff, QA, validation and other technical and managerial professionals involved with sterile products, hazardous or potent compounds, clinical materials, QC testing, drug development and medical research, should all benefit from the rigorous and practical discussions.
Description
Over the past few years there has been a great deal of industry discussion, numerous symposia and extensive publication on the advantages and issues related to the use of isolators. Building on this growing body of knowledge, along with actual experiences, case histories, and hands-on demonstrations, this course provides a more focused but thorough foundation in the key technical areas needed to select, validate and operate this important technology in a regulated environment.
Starting with the fundamental contamination control principles and application objectives, the course reviews available hardware and technology, design, selection and operational strategies, bioburden control technology and transfer devices and procedures. The ability to decontaminate and control bioburden and other residues is an essential requirement. Sterilization has become accepted yet cleaning has often become problematic. Effective options for both are covered in depth. Validation and regulatory issues and compliance are a major emphasis of the course covering installation and operational qualification, biocontamination control and sterility maintenance procedures, cleaning validation and routine process and environmental monitoring.