Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products Training Course :

This 90-minute online course provides an overview of the sources of microbial contamination and how to control such contamination. While many of the concepts presented relate to the manufacture of sterile drugs and devices, much of the material is also applicable to non-sterile products. Products contaminated with microorganisms can cause infection in the end user and result in significant financial loss to the manufacturer due to rejected product, recalls and litigation. In this course, you will gain an understanding of what microbial contamination is its sources, and what steps can be taken to reduce the risk of such contamination. Disinfection, sterilization and preservation will be discussed in terms of relevance and limitations. Other elements will also be addressed, including the importance of properly designed processes, equipment and training of personnel. The advantage of rapid methods over traditional microbiological testing will also be discussed.<br><br> <b>Module 1:</b><br> <li>Definition of Microbial Contamination</li> <li>Sources of microbial contamination in manufacturing processes</li> <li>Role of microbial biofilms</li><br><br> <b>Module 2:</b><br> <li>Definition of disinfection, sterilization, and preservation</li> <li>Use of heat, ionizing radiation, ethylene oxide and filtration as sterilization methods</li> <li>Disinfection versus sterilization</li> <li>Resistant organisms</li><br><br> <b>Module 3:</b><br> <li>Laboratory role in microbial contamination control</li> <li>Facility monitoring and training of personnel</li> <li>Testing for microbial contamination: Rapid testing versus conventional methods</li> <li>Questions & Answers</li>