Sterile Product Manufacturing Facilities (Third Edition)

This guide aims to offer a consistent interpretation of the latest FDA and EMA guidance, while allowing a flexible and innovative approach to facility design.

The International Society for Pharmaceutical Engineering (ISPE) announced the release of their latest Guide, ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition). This publication provides guidance on engineering facets of designing new sterile products manufacturing facilities and modifications of existing facilities.

“Understanding regulatory compliance is a challenging feat, one that can impact technological advancement and increase operational costs,” said John Bournas, ISPE CEO and President. “This guide aims to offer a consistent interpretation of the latest FDA and EMA guidance, while allowing a flexible and innovative approach to facility design.”

The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) focuses on best practices for an approach that is effective, cost-efficient, and in compliance with the latest FDA and European Medicines Agency (EMA) guidance. The guide is based on key principles, including:


  • The need to understand product and process requirements
  • Use of risk-based approaches
  • Role of barrier and isolator technology
  • Use of consistent terminology for classified environments
  • Categories for processing (open versus closed)
  • An integrated facility design approach

Updates to this new edition include:

  • Global facility design approach with examples of RABS, full isolator, and BFS recommended layouts
  • Harmonized area classifications
  • Additional details about local protection/Grade A air supply and particulate monitoring

ISPE will be showcasing the newly released, ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Third Edition) at their exhibit during INTERPHEX 2018. Find the new guide at http://www.ISPE.org/Publications/Guidance-Documents. Purchasers can also access their guide via ISPE’s new Guidance Document Portal.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.

For more information, contact:

Maria Robertson

Senior Director, Marketing Communications

International Society for Pharmaceutical Engineering (ISPE)

Tel: +1-301-364-9207

Email: [email protected]

http://www.ISPE.org

Share article on social media or email:

Article Source

Leave a Reply

Your email address will not be published. Required fields are marked *