Manufacturing facilities guide gets green light

Sheila Galatowitsch

TAMPA, FL — PHARMACEUTICAL companies seeking to cost-effectively build or renovate manufacturing facilities can turn to a new guide for help. After two years` preparation — and an extensive FDA review — the International Society for Pharmaceutical Engineering`s (ISPE) Sterile Manufacturing Facilities Baseline Guide is now available.

ISPE announced that the FDA`s Center for Drug Evaluation and Research (CDER) completed its review of the guide, which addresses the design, construction, commissioning and qualification of facilities for aseptic processing and terminal sterilization of formulated products, for parenteral use.

“Its main benefit will be in helping industry build facilities that are appropriate for the product requirements,” says Bruce Davis, chair of the ISPE group that prepared the guide, and section manager for U.K.-based Zeneca Pharmaceuticals.

The guide, which offers an interpretation of regulatory requirements, includes details on:

HVAC classifications;

engineering aspects of barrier isolation technology;

how engineering issues are interrelated with product development;

general cost data;

how architectural finishes impact facilities;

selection of process equipment and how it interrelates with facilities; and an

appendix on European Union (EU) requirements.

Clarifying confusing industry terminology was one of the key objectives of the guide, says Simon Shelley, head of Glaxo Wellcome`s mechanical engineering section in the U.K. and a member of the project team. Confusing terms lead to over-engineering and higher system costs, Shelley says. For example, the HVAC chapter addresses environmental conditions for rooms at rest and in operation, and attempts to clarify airflow pattern and air change requirements for both states.

The 126-page guide, which costs $250 for ISPE members and $405 for non- members, is available from ISPE at 813-960-2105 or www.ispe.org. It is the third of a series of 10 ISPE facilities engineering guide projects.