ISPE releases pharma water and steam systems guide

ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, has released its latest industry-impacting technical publication, "ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems".

The Guide provides an expanded understanding of how principles discussed in the ISPE Baseline Guide on Commissioning and Qualification can be applied to direct impact water and steam systems. ISPE says that the goal of the guide is to increase understanding of direct impact water and steam systems in the pharmaceutical and biotechnology industries.

"This guide offers an approach that can benefit companies by using an efficient and cost-effective use of resources," said Alex Konopka, chairperson, of the guide's task team.

"We've had lots of participation over a two-year period from those involved with all aspects of pharmaceutical water and steam systems in preparation of this Good Practice Guide," said Konopka, "A solid basis of 'process understanding' can lead to the economical commissioning and qualification within a direct impact water or steam system's validation life cycle. We've tried to pull together information that will allow practitioners to logically understand important considerations for the commissioning and qualification of these systems."

The guide also describes how the capital project management process, commissioning and qualification activities and ongoing monitoring work together in the validation life cycle for direct impact water and steam systems.

The importance of the risk assessment process used during design is crucial to ensuring quality product, the organisation says. The risk assessment process allows system designers and operators to gain "process understanding" of those project attributes, which affect water or steam quality, according to the authors.

For details visit www.ispe.org