The New Pharmaceutical Water and Steam Guide is Here!
Tuesday, January 23rd, 2007Remember in the ’70s movie, “The Jerk” when Steve Martin runs through the neighborhood screaming, “The new phone books are here, the new phone books are here!” That’s how I feel about ISPE’s latest good practice guide, Commissioning and Qualification of Pharmaceutical Water and Steam Systems. It is hot off the presses today (9 February 2007) and I know people are ready to snap it up.
Seriously, though, this industry-impacting Guide is written for pharmaceutical manufacturing professionals, and 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.
Ultimately, the goal of this Good Practice 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, and 2007 Chair of ISPE’s Critical Utilities Community of Practice.
“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 will be for sale at the ISPE Tampa Conference 12 February for $145 for Members (110 Euros) and $215 for non-members (165 Euros); or call ISPE Customer Service at +1-813-960-2105; or e-mail customerservice@ispe.org
An educational session, Risk Assessment as a Tool of Design, Implementation and Management of Critical Utilities, will be held at ISPE’s Tampa Conference 12-15 February held at the Hyatt Regency Tampa.
Another educational session on critical utilities will be presented 4-5 June at ISPE’s Washington Conference, 4-7 June . Both sessions will allow participants to get a first-hand look at information contained in the new Guide and interact with its authors.
