ISPE publishes guide on water and steam systems

By Anna Lewcock

- Last updated on GMT

Related tags Good automated manufacturing practice

The International Society for Pharmaceutical Engineering (ISPE) has
released its latest industry guide, covering the commissioning and
qualification of pharmaceutical water and steam systems.

This industry manual is the latest tome to be launched by the organisation, which regularly produces a range of technical advice publications for the pharmaceutical industry.

The ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems​ promises to show pharma companies how to "change [their] focus from a "qualify everything" approach, to a more efficient and cost-effective risk-based evaluation of individual systems components or process steps."

Covering the impact assessment process, key business considerations (including non-product quality issues such as health, safety and environment) and critical quality and process operating parameters among other topics, the guide provides a detailed explanation of the principles governing the commissioning and qualification of water and steam systems claims the ISPE.

"Ultimately, the goal of this Good Practice Guide is to increase the understanding of direct impact and water and steam systems in the pharmaceutical and biotechnology industries."​ says the organisation.

The publication is a follow-on building on the initial ISPE Guide on Commissioning and Qualification, one of the association's Baseline series created in partnership with the US Food and Drug Administration (FDA) and covering all aspects from facility design to process issues to Good Manufacturing Practice (GMP) regulations and government requirements.

"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 Alex Konopka, chairperson of the guide's task team.

"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 is available for $215 (€170) (or $145/€115 to ISPE members), either in book format or can be downloaded from the ISPE website here​ as a PDF.

The organisation has several other good practice guides currently undergoing revisions prior to re-publication, covering topics such as biologics for clinical materials professionals, good engineering practice, and heating, ventilation, and air conditioning (HVAC).

The ISPE range of publications are intended to provide practical information to help companies build on best practices to meet and exceed regulatory requirements. In addition to the good practice guides, the organisation also publishes the baseline series and a good automated manufacturing practice (GAMP) line, as well as providing resources on a range of other topics relevant to the pharmaceutical industry.

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