Aseptic Processing II

This course must be taught at a BioNetwork location.

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Level: Intermediate

Lecture Hours: 12.00

Lab Hours: 12.00

Total Contact Hours: 24.00

Currently Offered

Aseptic Processing II - Class begins December 3, 2018

Description

Build on the foundation you constructed in Aseptic Processing Level I with this course, a hands-on experience in which you hone aseptic operational skills in a simulated CGMP cleanroom environment.

We supplement each laboratory activity with vibrant classroom discussion so what you learn isn’t just theory. You actually relate topic knowledge to aseptic processes and function.

The course faculty correlate instruction with regulatory guidelines governing pharmaceutical aseptic activities.

Aseptic technique is vital to maintain product integrity and customer safety. Currently, this class is only offered at our BioNetwork Capstone Center in Raleigh, NC.

Topics Include

Meets six hours per day for four days and is aligned with regulatory guidelines. It covers:

Microenvironments Used in Aseptic Manufacturing/Testing
Isolator and BSC Laboratory Exercises
Closed System Aseptic Connections
Media Fill Process Simulations
Product Release Testing
Regulatory Aspects of Aseptic Processing
Biosafety Levels and Precautions
Endotoxins
Water Systems
Lyophilization Overview
History of Aseptic Processing
Deviation Investigations

Learning Objectives

Perform aseptic process simulations within LAFs, BSCs and Barrier Isolators.
Compare open-system to closed-system aseptic processes.
Understand endotoxins and methods used for testing their presence in manufacturing operations.
Define water’s role in parenteral drug manufacturing.
Conduct an investigation into aseptic processing issues.
Prescribe a CAPA report based on observations.
Apply hands-on experience in media fill process simulations.
Use hands-on experience of final product release testing.