This self-paced learning course provides comprehensive instruction on Sterile Manufacturing Practices in pharmaceutical manufacturing. This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Engaging knowledge checks are provided throughout each module, and the course concludes with a final competency assessment.
The program is presented in three modules: - approximate course completion time = *4.5 hours. Once you finish the first module, you will automatically be able to begin the next module.
Module 1 - Introductory Topics – approximately 1.5 hour
Provides key information relevant to microorganisms and sources of contamination, particularly in manufacturing areas. At the end of this module, you will be able to:
- Explain the basics of microbiology
- Recognize what constitutes a sterile versus non-sterile product
- Define Aseptic environment
- Identify how specific organisms can cause contamination
- Recognize how Mother Nature is a potential contamination source
- Identify other potential sources in a manufacturing area
Module 2 - Intermediate Topics – approximately 2 hours
Provides common terminology used in sterile manufacturing procedures such as: Clean Room, Unidirectional air, First air, Restricted access barriers (RABS) versus isolators, autoclave cycle, and isolators. At the end of this module, you will be able to explain:
- HVAC Requirements
- Clean Room requirements and clean room preparation
- Personnel and material flow
- Primary packing components
- Sterilization with both heat and radiation
- Steam in place (SIP)
- Terminal Sterilization
- Sterile Filtration
Module 3 - Advanced Topics – approximately 2 hours
Provides information related to the practical application of Sterile Manufacturing Practices. At the end of this program, you will be able to:
- Describe routes of administration and associated patients
- Successfully complete the gowning process
- Explain the interrelation between materials, people, equipment and environment for aseptic processing
- Be aware of the critical controls in place
- Identify specialized filling technologies
- Providing an overview of lyophilization
- Explain container-closure integrity (CCI)
- Perform visual inspection
- Explain clean room monitoring
*Completion times included are approximate and based on the amount of content included in each section. Content is self-paced, driven by the learner.
By completing/passing this course, you will attain the certificate NSF eLearning Certificate of Completion (Archived)
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