ISPE updates sterile manufacturing guide

Provides information on best practice recommendations

The US International Society for Pharmaceutical Engineering (ISPE) this month will release an update of its Baseline Guide: Sterile-Product Manufacturing Facilities (Second Edition).

The update, which replaces the original, integrates and consolidates all of ISPE’s latest best practice recommendations on sterile manufacturing facility design into one document.

When the original guide was released in 1999, it provided a resource to help interpret and implement US FDA regulations with respect to design and operations used for the manufacture of sterile pharmaceutical products.

However, as technology advanced, aseptic processing in manned cleanrooms was no longer considered current GMP and ISPE began tracking and communicating new, better methods of sterile manufacturing design.

The update is aimed at an international audience and incorporates a comprehensive tabulation, explanation, and comparison of the cleanliness designations found in FDA, EMA, and ISO guidance documents, allowing for better harmonisation in global facility design and a wider breadth of regulatory compliance internationally.

Technical updates contained in the guide include the use of RABS and isolator technology; facility design; best practices for terminally sterilised and aseptically processed sterile products; and updated guidance on quality attributes of construction and finishes for different grades of facility.

Diagrams and text explain and compare GMP requirements, providing a platform for developing compliant solutions and allowing firms to follow several different routes to reach a compliant solution.