Aging Aseptic and Biologic Manufacturing Sites: Design and Renovation for Compliance

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Decades of mergers, acquisitions and business consolidations have resulted in a global shortage of aseptic fill sites and flexible biological manufacturing plants.

Only a limited number of facilities remain — in poor condition with generally weak infrastructures — producing and performing well beyond their anticipated useful life span.

And that's despite substantial new GMP regulations, general engineering practices and innovative design philosophies introduced by the FDA and international regulators.

Of course, if you are a drug sponsor or contract manufacturer, there are massive compliance risks awaiting you in these facilities.

Leading Expert Tells How to
Extend Your Sites' Life by 10-20 Years

In this new management report, you'll explore the modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years.

These upgrades can also make facilities more compliant, cut down on operating risks and improve performance.

Expert Herman Bozenhardt will tap into his 39 years of experience to show you 3 key areas you must address to properly redesign and renovate your aseptic and biologic facilities -- and reduce the risk of enforcement actions from the FDA and international regulators.

The 3 critical areas you must deal with are: 1) process core, 2) architecture, and 3) heating and ventilation and air conditioning (HVAC).

Best Practices to Employ and
Details You Need to Know

In the report, you'll get the details you need to put best practices to use in these 3 areas, such as:

  • How and why you must use gray and white space in your manufacturing process core

  • How unidirectional flows and architectural layout eliminate contamination risks

  • Why you must consider HVAC upgrades, air-handling unit modernization, segregation, isolation and air distribution. (They're a must with promised “intense” FDA inspections.)

  • Architectural finishes and upgrades that reduce operating risks

  • How to safely and compliantly build out single use/disposables process systems

  • How modular/podular construction will help you build better facilities faster

  • The top operational upgrades in material handling that manufacturing professionals like you must know about

  • And much more

Drugmakers continue to take on significant risk today by manufacturing at out-of-date aseptic fill sites and biological manufacturing plants.

Let Herman Bozenhardt and Aging Aseptic and Biologic Manufacturing Sites: Design and Renovation for Compliance show you how to bring your facilities into compliance — with fewer risks and far better performance.

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Table of Contents

  • Introduction
  • 3 Major Areas
  • Process Core
  • Architecture
  • And More …

View the entire TOC

Who Will Benefit

  • Aseptic drug and biologic company executives
  • Production managers
  • Plant managers
  • Engineers
  • Quality operations managers
  • New employees/team members
  • Those who need to communicate internally with engineering or operations personnel responsible for new production

Meet the Authors

This report is largely drawn from comments made during an FDAnews webinar by Herman Bozenhardt of Bozenhardt Consulting Services. Bozenhardt has 39 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance.

His expertise covers a wide spectrum of processes and computer systems and related technologies, and he is a recognized expert in the area of aseptic filling facilities and systems.

Bozenhardt has extensive experience in manufacturing therapeutic biologics and vaccines via cell culture technology, human plasma derivation and egg-based technologies.

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