Sterile Manufacturing Practices

This self-paced course provides comprehensive instruction on sterile manufacturing practices in pharmaceutical production. This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Each module contains engaging knowledge checks, and the course concludes with a final competency assessment.

The program contains three modules with an approximate course completion time of 4.5 hours.*

Module 1: Introductory Topics (1.5 hours)

Provides key information on 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 an 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 (2 hours)

Covers common terminology used in sterile manufacturing procedures, such as clean room, unidirectional air, first air, restricted access barrier systems (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
• Depyrogenation
• Steam in place (SIP)
• Terminal sterilization
• Sterile filtration

Module 3: Advanced Topics (2 hours)

Provides information on 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
• Provide an overview of lyophilization
• Explain container-closure integrity (CCI)
• Perform visual inspection
• Explain clean room monitoring

*The course is self-paced so completion times are approximate, based on the amount of content in each section.