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Aseptic Processes and Behaviors

Take a deep dive into critical cGMP requirements for aseptic processing with our comprehensive course designed to equip you with the essential knowledge and skills to prevent contamination risks and maintain regulatory compliance.

Engage in interactive learning, including a case study that mirrors real-world challenges, and apply your knowledge through practical exercises and discussions.

Enhance your ability to implement effective aseptic processes within your operation and ensure the highest standards of product integrity and patient safety.

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Brief Overview of This Pharma Aseptic Processing Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

2 Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

1.6

* This class is only offered privately to groups of six or more. We can conduct this class virtually or at your facility. 

Upcoming Classes

Upcoming Training Classes on Pharmaceutical Aseptic Processing

SkillsLab $2195

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
APP San Diego, CA 14 Jul 2026 15 Jul 2026 8:00AM - 5:00PM Pacific US Time In-Person REGISTER
APP San Diego, CA 29 Sep 2026 30 Sep 2026 8:00AM - 5:00PM Pacific US Time In-Person REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

What We Cover in This Aseptic Processing Training Class

This course equips participants to prevent contamination risks and maintain regulatory compliance in aseptic processing. Through interactive learning, practical exercises, and real-world case studies, you'll gain essential knowledge and skills enhancing your ability to implement effective aseptic processes within your organization's operations. 

Course Overview
SkillsLab Class

Aseptic Processing Equipment and Components

  • Types of product container closures
  • Ready to use vs. prepared container closure components
  • Filling systems
  • Preparation of filling system components
Learning Activity!

Contamination Controls

  • Sources of contamination
  • Common controls
  • Cleaning and disinfecting
Learning Activity!

Facility Design and Controlled Environments

  • Cleanrooms
  • Cleanroom classifications
  • Cleanroom controls
  • Critical surfaces and environments
Learning Activity! 

Environmental Monitoring

  • Environmental monitoring methods
  • Trending data
  • Establishing alert and action limits
  • Excursion investigations
Learning Activity! 

Aseptic Behaviors and Techniques

  • Personnel skills, requirements, and training requirements
  • Cleanroom behaviors
  • First air principles
  • Aseptic techniques
  • Aseptic connections
Learning Activity! 

Sterilization Methods

  • Regulatory requirements
  • Sterilization methods and selection
  • Sterile filtration
  • Depyrogenation
  • Moist heat sterilization
  • Radiation sterilization
Learning Activity! 

Aseptic Process Simulations

  • Description and purpose of the APS
  • Protocol design and documentation
  • Inherent and non-inherent interventions
  • Worst-case conditions
  • Growth medium and testing
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Explain the criticality of producing sterile pharmaceuticals for patients, to guide your work

Describe the overall key steps involved in the complex workstream of producing sterile pharmaceutical products by aseptic processing

Describe the design and ISO classifications of cleanrooms and review those against manufacturing operations to promote effective management

Interpret requirements for monitoring and maintaining cleanrooms to meet the ISO and EU classifications

Discuss contamination controls and aseptic processing behaviors and techniques to be applied

Describe aseptic process simulation methods and requirements

Explain the significance of documentation requirements and impacts of deviations, to better manage your system

Who Should Attend

Who Should Attend

  • Cleanroom operators
  • Process engineers
  • Cleanroom and lab supervisors
  • Lab technicians
  • Microbiology analysts
  • QA/QC technicians
  • Validation specialists
  • Compliance officers
  • Operations managers
  • Regulatory affairs personnel
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