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Aseptic Processing Course


Operation of Single-use Technologies

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Overview

(TROPMOB01 - Two-day course)
Using a combination of theory and hands-on instruction, participants will learn the key procedures and “best practices” methods involved in the operation of disposable single-use components, including filters, connectors, bags, mixers and tubings. Installation, flushing, sanitization and integrity test procedures are also taught and discussed.

This two day course covers all operation aspects of disposables in pharmaceutical and biopharmaceutical production. Participants will be assessed to gauge their understanding of the different topics taught during the training.

Which of your challenges does this course address?
  • Inappropriate integration of disposable components leading to operational complication.
  • Damage to bags.
  • Failed sterility due to improper sampling or connection practice.
  • Low yields in processes using single-use components.
  • Difficulty transferring from fixed stainless to single-use processes.
What will you be able to do after attending this course?
You will understand the best practice techniques for disposable component integration, installation, the importance of appropriate flushing, operation and product recovery procedures including how to:
  • Implement best practices procedure for disposable installation and handling.
  • Optimize your flushing or wetting procedures.
  • Establish robust product recovery.
  • Make appropriate decisions when there is a sterility or integrity failure.
  • Institute appropriate rinsing protocols for your disposable assembly.
What will you receive?
  • A copy of the course materials.
  • A certificate of attendance.
Hands-on Practical section
The practical element of this course covers how to:
  • See how a system design is translated to an actual operating single-use assembly.
  • Understand how secure connections are made in single-use systems.
  • Install single-use components and assemblies.
  • Carry out aseptic connections.
  • Perform integrity test procedures on capsules.
  • Carry out mixing and fluid transfer.
Who should enroll?
This course is designed for operators , technicians or manufacturing associates with a basic understanding of disposables technology in biomanufacturing or previous experience in pharmaceutical processing using traditional stainlesss steel components.
Course Program

Day 1 *8:30 – 17:30
  • Introduction
  • Key drivers and regulations for single-use systems.
  • Review of single-use components.
  • Making sterile and aseptic
    connections + Workshop.
  • Quality aspects in the correct
    operation of single-use systems.
  • Single-use mixing systems + Workshop.
  • Overview of integrity testing
    procedures for single-use assemblies.
  • Avoiding yield and product loss.
Day 2 *8:30 – 17:30
  • Critical aspects in connecting and operating single-use systems.
  • Checking the usability of a single-use system + Workshop (3 different scenarios).
  • Industry case studies.
  • Assessment.
  • Safe disposal of single-use systems.
  • Conclusion.
*Includes two coffee breaks and lunch boh days

Dates and Locations: Click here
This training can also be delivered on your site at a convenient time. Please contact your local Merck representative or send an email to accessknowledge@merckgroup.com to discuss this option.

Enrollment limited to 12 participants
Due to the interactive nature of this course, enrolment is limited to 12. We recommend early booking to ensure a place.

Ordering information
Catalogue number: TROPMOB01

Price
Please contact your local Merck representative or send an email to accessknowledge@merckgroup.com for a quote.

Printable Course Description

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