ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases
The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases has just been published and is a “first of its kind” document to address an issue that has been costing the pharmaceutical industry millions of dollars every year.
Product quality is extremely important in the Life Sciences industry and sampling of critical utilities is part of this process. When any step of the sampling process isn’t done properly, errors may be introduced and misrepresentative data can create costly and unnecessary investigations and corrective actions.
Sampling is an involved and complicated process and very little regulatory guidance exists on the topic. This Good Practice Guide provides expert guidance on all aspects of sampling including sample valve design, the number, location, and placement of sample valves, sampling technique, frequency, and sample storage including delivery to the laboratory for testing. The guide also addresses the purpose of sampling at a particular location—whether it is to meet regulatory requirements, to verify that a process is operating under a state of control, for diagnostic purposes, or for method validation.
The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases will prove to be an indispensable tool to all users of water, steam, and process gases. If this guide eliminates even one costly investigation at your facility, it will pay for itself handsomely.
By: Brian Hagopian, CPIP
Team Leader, Sampling Guide Task Team
Chemist, Clear Water Consulting, Inc.
The ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases, is a direct result of the generous and dedicated commitment of the following subject matter experts, who gave their time, industry experience, and expertise in the Critical Utilities arena:
Michael Baumstein, Pfizer, Inc., USA
Rod Freeman, Beckman Coulter, Inc., USA
Andre Gill, PE, Andre Gill Engineering, USA
Michelle Gonzalez, PE, Amgen, Inc. (retired), USA
Brian Hagopian, CPIP (Team Lead), Clear Water Consulting, Inc., USA
Jeppe Kjems, CU Engineering, Denmark
Joseph Manfredi (Chapter Lead), GMP Systems, Inc. USA
Ruby Ochoa, Trace Analytics, LLC, USA
Aravind Palinvelu, Roche, Singapore
Brian Pochini, CPIP (Chapter Lead), Sanofi, USA
Teri C. Soli, PhD, Soli Pharma Solutions, Inc., USA
Philip Sumner, PE, Pfizer, Inc., USA
Michael Tomaselli, Filters, Water, and Instrumentation, Inc., USA
Nancy Tomoney, West-Ward Pharmaceuticals, USA
Michael Vestermark, Novo Nordisk Biopharm, Denmark
Peter Vishton (Chapter Lead), Independent Consultant, USA
Anders Widov, Wiphe, AB, Sweden