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Course offering number:0806-408
Course ID:
2215
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products
June 24, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
AN ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for persons who are directly involved with the manufacture of sterile drugs and medical devices, as well as other products that are required to be free of certain objectionable organisms. It is recommended for:
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Production Managers
- QC/QA Managers
- Environmental Monitoring Personnel
- QC/QA Lab Personnel
- Process Design/Engineering Personnel
- Maintenance Managers
Description
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.
Module 1:
Definition of Microbial Contamination
Sources of microbial contamination in manufacturing processes
Role of microbial biofilms
Module 2:
Definition of disinfection, sterilization, and preservation
Use of heat, ionizing radiation, ethylene oxide and filtration as sterilization methods
Disinfection versus sterilization
Resistant organisms
Module 3:
Laboratory role in microbial contamination control
Facility monitoring and training of personnel
Testing for microbial contamination: Rapid testing versus conventional methods
Questions & Answers