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Aseptic Processing Overview and Validation

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  /  FDA Regulatory Compliance  /  Aseptic Processing Overview and Validation

Aseptic Processing Overview and Validation

$49

About this course

Watch RECORDED Session for Just $49

Training Duration: 90 Minutes

Place: Any media device

Recorded On: April 25, 2019

Access any day, anytime, unlimited times as per your convenience*                                                                                                                                                                           Sr. No. 052042519


This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls, and acceptable personnel behaviors. Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact on product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met. The role of Media fills will also be explained; along with details on how to successfully perform a media fills.

 

Session Highlights : 

Topic 1:   Basic Micro Review        

  • The role of environmental monitoring
  • Types & sources of microorganisms
  • The impact of microorganisms on the product and patient health and safety

 

Topic 2:  Review of Aseptic Processing Basics       

  • Cleanliness classifications
  • Process differences between aseptically produced and terminally sterilized product
  • Relation of manufacturing and handling procedures to sources of product contamination
  • the differences between and the purposes of cleaning, disinfection, and sanitization
  • Proper cleaning techniques
  • The role of isolator technology

Topic 3:  Review of Clean Area Behaviors    

  • Personnel gowning requirements
  • Good clean area behaviors/practices
  • Practices to avoid – and why
  • Review site-specific EM/aseptic behavior observations/risks

Topic 4:  Aseptic Validation

  • The purpose of media fills, and elements critical to their success

 

Why should you attend :

Course Objectives: At the completion of this course, attendees will be able to:

  • Explain the difference between Aseptic and Bulk processing
  • Understand the facility and personnel requirements necessary to maintain microbial control
  • Principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring
  • Understand the gowning requirements associated with different cleanroom classifications
  • Identify behaviors that are or are not appropriate when working in controlled areas, and why
  • Identify ways that they can impact/improve site-specific EM and aseptic behavior issues
  • Explain the basic principles of aseptic processing, including:
  1. Cleanliness classifications
  2. Process differences between aseptically produced and terminally sterilized product
  3. Relation of manufacturing and handling procedures to sources of product contamination
  4. The differences between cleaning, disinfection, and sanitization
  5. Proper cleaning/disinfectant technique
  6. Elements of a robust environmental program and why EM is important
  7. The purpose of media fills, and elements critical to their success
  8. The role of isolator technology

 

Who Should Attend : 

  • Engineering /Technical Operations
  • Operations
  • Quality Assurance
  • Quality Control
  • Validation

 

**In this Recorded Sessionyou can listen to Q&A which includes direct answers from our expert speaker.

*Instruction kit to access the session will be emailed within 6 hours.

Recommended Training Course :

Food Safety and Security: HACCP FSMA


 

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