Harmonization of regulations for high-purity pharma water systems, “although a noble goal, has not been achieved,” says Cameron Sipe, P.E., a Principal Project Engineer and Subject Matter Expert with Pfizer.
It is for this reason that there are significant hopes within the industry that ISPE’s new Baseline Guide for Water and Steam Systems (available from ISPE.org) will provide some much-needed coordination. Sipe has chaired the committee to revise ISPE’s original guidance (published eons ago, in 2001), and answers our questions about what the new baseline guide will mean. Note: The interview is followed by a roundup of new technologies in pharma grade water.
PhM: What does the industry still struggle with in regards to use and control of water and steam systems, and how will the new guide address these issues?
C.S.: The most significant struggle in the industry for many years has been the numerous guidelines and books out there that provide guidance and recommendations for high purity water systems and clean steam systems, many of which have conflicting information. Additionally, the pharma/biotech industry has been a global industry for a number of years now. Therefore, the clean utilities utilized to manufacture our products must meet the numerous requirements of a multitude of regulatory agencies around the world.
As you can imagine, there are numerous differences in the regulations from various countries. These regulations continue to change but often times slower than water purification technology. Harmonization of these regulations, although a noble goal, has not been achieved. The desire to utilize emerging technologies for purification and especially for monitoring the quality of clean utility systems has added to the struggle. Recognizing these struggles and addressing them was the major goal for the revision to the ISPE Baseline Guide for Water and Steam Systems. The team attempted to build on the significant original content of the first edition by addressing the regulations for a global market while recognizing the advances in purification and monitoring technology.
PhM: It was time for a revision of this baseline guide, but how much of it is in response to and reflects changes in industry and FDA’s risk- and science-based initiatives?
C.S.: Edition 1 of the baseline guide was published in 2001 but the content was written several years earlier. There have been numerous changes in the industry, many changes in regulations, and new guidelines/regulations published over the past 10 years approximately. When edition 1 was written, the industry was in a “cover all the bases” mode for documentation. Therefore edition 1 was written in that light. Additionally, since the Baseline Guide for Water and Steam was one of the first ISPE Baseline guides, the core team of authors felt they had to cover numerous areas relating to water and steam that had no guidance documents.
Since that original publication, numerous other baseline guides, good practice guides, and regulatory guidelines have been published which cover most of these related areas. Edition 2 of the Water and Steam Guide references these other guides heavily and tries not to duplicate information. The “risk-based” or “science-based” approach is one of the latest industry trends covered in other baseline guides or good practice guides. Edition 2 mentions these approaches and how they apply to water and steam systems but then references other guides for specific details.
PhM: How will the updates reflect the increased use of PAT and support real-time monitoring and control? In your view, are manufacturers realizing the potential of PAT to monitor and optimize their water and steam systems?
C.S.: When edition 1 was published, on-line monitoring had been utilized for a number of years. However, many people in the industry were skeptical about its use for documenting the quality of the water and steam. This skepticism was due in part to questions on reliability of instruments and part to reluctance to change and answer questions associated with the change. Therefore, the on-line instrumentation, in many cases, was utilized primarily for maintenance monitoring and early detection of quality issues. Advances in instrument technology and reliability have promoted the recent industry trend toward PAT and reliance on on-line instrumentation. Edition 2 addresses this trend by significantly enhancing the instrumentation and controls chapter. This chapter not only provides specifics on applying on-line instrumentation and PAT but also discusses emerging technologies such as rapid micro testing.
PhM: In terms of C&Q, what are the major points of emphasis, and are there major changes from the 2007 guide for commissioning & qualification of water and steam systems?
C.S.: Good Practices Guide (GPG) for C&Q of Water and Steam Systems was published after Edition 1 of the Baseline Guide for Water and Steam. Edition 2 of the Baseline Guide for Water and Steam recognizes the detailed information included in the C&Q GPG. Many of the authors for the C&Q guide also participated in the Edition 2 team. We attempted to maintain consistency between the two guides but allow the C&Q guide to be the primary source for detailed information. Therefore, the C&Q chapter of Edition 2 heavily references the C&Q GPG and attempts to avoid repetition of content. However, the recent industry trend for a risk-based approach to C&Q is discussed and how it may be applied to water and steam systems.
PhM: Are manufacturers embracing new technologies for microbial ID and control in their water and steam systems, and how are they covered in this guide?