Sterile Manufacturing Practices

Content
6 modules

Rating

Course Length
4.5 hours

Instructor
NSF Learning

Description

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
  • Depyrogneation
  • 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.

Certificate

By completing/passing this course, you will attain the certificate Pharma Certificate

1.
Introduction Notes
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Sterile Manufacturing Practices - Introduction Program
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Intermediate Notes
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Sterile Manufacturing Practices - Intermediate Program
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Advanced Notes
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Sterile Manufacturing Practices - Advanced Program
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Added 9 months ago, by Sandra

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