Fundamentals of Aseptic Pharmaceutical Engineering

Timothy D. Blackburn, MBA, P.E.

Course Outline

This course offers the student a fundamental understanding of Aseptic biopharmaceuticals that can be applied to practical engineering and architectural design.

This course includes a multiple choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

Learn essentials of Aseptic operations to enable better understanding that can be applied to engineering and architectural design. At the conclusion of this course, the student will be able to:

• Understand the fundamental elements of Aseptic processing;
• Know the preferred method of producing sterile products (terminal sterilization);
• Understand parenterals and the typical finished forms;
• Understand why parenterals need to be sterile and the affect on patients when they are not;
• Know the sources of contamination in an Aseptic area and how to incorporate design elements to mitigate;
• Understand basic cleanroom criteria;
• Understand the fundamental elements of Aseptic Fill/Finish requirements to enable design to facilitate;
• Understand monitoring requirements;
• Know the difference between SVP's and LVP's;
• Understand basic Lyophilization interface in the design;
• Be able to explain a typical PFD for Aseptic parenteral operations/options;
• Be able to understand and layout a typical Aseptic core concept considering material and people entry issues;
• Understand SAL;
• Know fundamental issues associated with Barrier Isolators;
• Understand basic and practical design issues/considerations, including;
  o HVAC
  o Architectural
  o Utilities
• Understand an overview of Commissioning and Validation; and
• Realize the importance of the Regulatory environment.
  
  

Intended Audience

Engineers, Architects, Project Managers, or others interested in Aseptic Biopharmaceutical Engineering.

Benefit to Attendees

Quickly learn key essential elements that would require hours of research and/or years of experience.

Course Introduction

Aseptic Pharmaceutical Engineering is perhaps the most interesting to an engineer compared to other pharma/biotech projects. There are two primary reasons it is a favorite. The first is the technical challenge. Things that can be overlooked in non-sterile manufacturing will present significant issues with Aseptic. The second is that there is clearer direction in regulatory directives as to fundamental scope requirements. Engineers like to begin with a firm scope. There is less to debate, and clearer expectations as to the end product.

This course provides an introduction to Aseptic operations in the Biopharmaceutical industry. Due to the ever-changing regulatory environment, general practices will be discussed without specific reference to the predominant FDA and EU guidances as much as possible. The goal is to provide the student with a well-rounded introduction to Aseptic operations. However, refer particularly to FDA's 21 CFR parts 210 and 211, as well as latest guidance documents.

Course Content

The course content is in a PDF file (86 KB) Fundamentals of Aseptic Pharmaceutical Engineering . You need to open or download this document to study this course.

Table of Contents

• Introduction
• Explanation of Aseptic and why it is needed
• Overview of the manufacturing process
• Overview of the fill/finish process
• The fill environment and operational requirements
• Practical design considerations
• Commissioning and Validation highlights
• Introduction to Regulatory Environment and Resources
• Course Summary
  

Course Summary

This course provides an introduction to Aseptic Pharmaceutical Engineering. After taking this course, it will be up to the student to carefully study the regulations of the countries in which he or she plans to sell their product. As well, other industry publications are available and helpful. Equally importantly is to understand your process requirements and product sensitivities.

Quiz

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.

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DISCLAIMER: The materials contained in the online course are not intended as a representation or warranty on the part of PDH Center or any other person/organization named herein. The materials are for general information only. They are not a substitute for competent professional advice. Application of this information to a specific project should be reviewed by a registered architect and/or professional engineer/surveyor. Anyone making use of the information set forth herein does so at their own risk and assumes any and all resulting liability arising therefrom.

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