BETHESDA, Md., Oct. 16, 2019 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced the release of its latest guide, ISPE Baseline® Guide: Water and Steam Systems (Third Edition). This guide provides in-depth guidance for the design, construction, operation, and lifecycle management of water and steam systems. Industry professionals can better understand Good Manufacturing Practices (GMPs), to comply with established regulations and new expectations.
"This guidance document explains recent changes in compendial documents for water for injection production methods in addition to traditional distillation processes with newer interpretations, technology, and definitions," said Brian Pochini, CPIP, Principal Engineer, Sanofi, Guide co-lead.
Additional changes include discussions on the global harmonization of water quality attributes, comprehensive pretreatment design, rapid microbial monitoring, ozone for ambient sanitization, and membrane technologies.
"The pharmaceutical industry can apply these guidelines to their facility operations to enhance systems knowledge and ensure water critical quality attributes in new and existing water systems," noted Gary Zoccolante, Plymouth Rock Water Consultants, President, Guide co-lead.
Key topics discussed in this guide:
- Changes in traditional distillation methods
- Advancements in WFI procedures
- Global harmonization of water quality attributes
- Comprehensive pretreatment design
- Ozone for ambient sanitization
- Membrane technologies
"ISPE and leading pharmaceutical water SMEs have contributed their combined experience and water knowledge of more than 500 years to produce a highly valuable resource document adhering to regulatory expectations in today's industry," said Nissan Cohen, Biopharmaceutical Water Doc, Owner, Guide co-lead.
Purchase the ISPE Baseline® Guide: Water and Steam Systems (Third Edition) online, available at http://www.ISPE.org/Publications/Guidance-Documents, among ISPE's other detailed education resources on a variety of industry topics.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world's largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.
For more information, contact:
Amy Henry
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1- 813-960-2105 Ext. 277
Email: [email protected]
http://www.ISPE.org
SOURCE ISPE
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