Chemical and microbial contaminants can enter steam systems in a variety of ways, and in the design of clean steam systems this must be avoided. Process gases has been sponsored by engineering executives from owner organizations, consulting firms, and ispe senior management. Commissioning and qualification of pharmaceutical water and steam systems ispe good practice guide. Typical recommendations for the minimum feed water quality for pure steam generators include. Pathways for contamination include leakage, air being piulled into the system and grow through from a contaminated external environment. Pharmaceutical water systems, first edition, 1997, theodore h. The us international society for pharmaceutical engineers ispe is to publish the ispe baseline guide volume 4. Connecting pharmaceutical knowledge ispe good practice guide. In this process water is evaporated, producing steam.
Ispe water and steam systems baseline guide author. Process streams include bodily contact surfaces of invasive medical devices and fluid paths of medical devices that. Recommended monitoring in pure steam systems and pure steam quality requirements the manufacturer specifications of the pure steam generator should be fulfilled. Pharmaceutical utilities, current regulation, qualification. Systems that generate and distribute water and steam that may come into contact with productor process contact surfaces, or that are used in the testing of product, are subject to commissioning and. Biopharmaceutical process development and manufacturing.
He is the secretary of ispe critical utilities international steering committee and holds the vice. They deal with side effects of an industrial production such as waste disposal. Guide commissioning and qualification of pharmaceutical. This classroom course has been substantially updated to feature the guiding principles of the ispe baseline guide. Commissioning and qualification of pharmaceutical water. Water and steam systems second edition with particular emphasis placed upon microbial control and laboratory water as well as key design philosophies. Produced from pretreated water no volatile boiler chemicals.
Low molecular weight impurities are carried with the water mistdroplets, which are entrained in the steam. Storage and distribution of pharmaceutical waterapplicationof. Water and steam systems official requirements for pure steam also referred to. Maintenance and repairs these system interventions. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext.
This guide should be considered as supporting guide to the ispe baseline guide. This is significant because critical systems, such as fermentation, require a higher level of documentation. Ispe releases updated water and steam systems baseline. The ispe baseline guide water and steam systems third edition aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems. Superheated steam is defined as steam that is above its saturation temperature. Applied risk management for commissioning and qualification, and is complementary to the ispe good practice guide. The ispe good practice guide on sampling for pharmaceutical water, steam, and process gases was created for users of water, steam, compressed air or process gases and impacts facilities, production, and quality control personnel within a facility. America as project manager and sales manager primarily with water systems. Anders is one of the authors of ispe baseline guide volume 4 on water and steam systems and has also been involved in several good practice guides from ispe.
Ispe baseline guide ispe baseline guide volume 4 ispe baseline guide volume 5 ispe baseline ispe baseline volume. The ispe cannot ensure and does not warrant that a system managed in. Sanitization sanitization is designed to reduce contamination or bioburden by 99. Pharmaceutical ultrapure water systems what pharma can learn. Steam disengages from the water leaving behind dissolved solids, nonvolatiles, and high molecular weight impurities. Clean steam must be free of contaminants at the point of use. Dec 15, 2011 the water and steam systems second edition is the only comprehensive guidance of its kind and aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current good manufacturing practices cgmps and comply with existing regulations and related guidance. Superheat occurs in steam distribution systems when the. Thus, the risk analysis culminates in establishing the project documentation requirements table a.
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 costeffective riskbased evaluation of individual systems components or process steps. Rouging is common in puw, wfi and pure steam systems. Applied risk management for commissioning and qualification may be applied to gmp water and steam systems. Pharmaceutical utilities, current regulation, qualification and validation. This guide aims to provide an example of how the principles discussed in the ispe guide. Jan 01, 2014 this guide aims to provide an example of how the principles discussed in the ispe guide. Nov 14, 2011 ispe updates water and steam systems guide. Science and riskbased approach for the delivery of facilities, systems, and equipment. Clean steam has been used throughout this course, and is used in the ispe baseline guide, it is not used universally, and can have different meaning to different people. Usp 39 s2 revisions to informational chapter water for pharmaceutical purposes joe manfredi gmp systems, inc.
The ispe baseline guide water and steam systems third edition aims to assist with the design, construction, operation, and lifecycle management of new. The water and steam systems second edition is the only comprehensive guidance of its kind and aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current good manufacturing practices cgmps and comply with existing regulations and related guidance. Sampling for pharmaceutical water, pharmaceutical steam, and process gases water sampling chapter two primary groups to monitor and control. Examples of service systems are the systems of drinking water, sanitary water, electricity. The guide focuses on items which directly affect quality. Water and steam systems second edition has been expanded to include chapters on laboratory water systems and the latest theories and industry practices addressing the rouge phenomenon in high purity water and pure steam systems. Approaches to commissioning and qualification of pharmaceutical water and steam systems second edition ispe guide. Me systems typically require plant steam at 80 120 psig me systems operate under pressure, and typically deliver wfi at 80c 100c. Superheated steam, steam containing excessive liquid water, and steam containing excessive boiler additives or contaminates such as rust should be avoided. A separator removes fine mist and entrained impurities, including endotoxins. Chemical free steam is typically a separate plant steam system generated without chemical additives, but it should not be considered clean steam.
Approaches to commissioning and qualification of pharmaceutical water and steam systems, discusses practices and activities associated with the commissioning and qualification verification of pharmaceutical water and steam systems. This barcode number lets you verify that youre getting exactly the right version or edition of a book. Pw and wfi storage and distribution systems design. Rouge in pharmaceutical water and steam systems ispe. Cop held a series of workshops on pharmaceutical water and steam. The usp monograph also includes guidance on sampling. Ispe newsletter operation maintenance 631 design accessibility within the system in case no detail plan should be available for a new water steam system dimensional drawings andor layout of a package unit, it is recommended to request an appropriate document like a piping diagram or manufacturing schematic of the entire system.
New chapters also cover microbiological considerations, such as biofilm formation, use of. Water and steam systems second edition will be available for preorder at the 2011 ispe annual meeting, taking place november 69 in grapevine, texas, and will be available for purchase on the ispe website by 15 december 2011. Storage and distribution systems design and operation a practical comparison. Commissioning, qualification and sampling new guides from ispe. Ispe, the international society for pharmaceutical engineering, is a society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory. The ispe baseline guide for steam and water systems and the asme bpe guidelines are the most directly related and current standards for steam system and related component. Pharma water chapter joe manfredi gmp systems, inc. High purity water systems 793 ispe baseline guide volume 4. This second edition of the ispe good practice guide. Commissioning, qualification and sampling new guides from. Commissioning and qualification of pharmaceutical water and steam systems ispe good practice guide on. Ispe releases updated water and steam systems baseline guide.
Addresses changes to industrial practices and global regulations. Water and steam systems 0th edition by ispe author isbn. Clean and pure steam systems biopharmaceutical industry. Science and riskbased approach for the delivery of facilities, systems and equipment, and the ispe good practice guide. Page 5 commissioning and qualification of pharmaceutical water and steam systems table of contents introduction 7 1. Project management for the pharmaceutical industry. Commissioning and qualification of pharmaceutical water and steam systems. Clean steam is steam that is generated from a regulated water source and is distributed to meet a specific level of quality.
Ispe baseline guide water system share and discover. The principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications, including the essential concepts and principles of systems. Baseline pharmaceutical engineering guide volume 4 water and steam systems gampforum gamp 5. Volume 4 water and steam systems second edition, and the ispe good practice guide. The revised and expanded second edition builds on the water and steam systems. It is intended to help meet good manufacturing practices gmps and comply with regulations and related guidance. Pq methods of sampling and microbial monitoring of new systems are described in the fda guide to inspection of high purity water systems see phase below. They are not customized systems to specific users but distributed with general networks serving all the users of the factory. Suggested sampling points can be found in the chapter qualification of pure steam. Oct 16, 2019 the international society for pharmaceutical engineering ispe announced the release of its latest guide, ispe baseline guide.
Chemicalfree steam is sometimes confused with clean steam. Ispe baseline guide water system linkedin slideshare. Terms such as pure steam, pyrogenfree steam and low endotoxin steam are encountered in. Design of purified water and water for injection systems.
The discussions focused on three aspects of rouge, including. Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations. Commissioning and qualification of pharmaceutical water and steam systems table of appendices appendix 1 typical wfi generation and distribution system component classification example appendix 2 process water, pure steam, and process steam appendix 3 system classifications at points of usesubloop. Routine visual inspections cleaning of the still during shutdown periods chlorine and ammonia removal before me low tds 25. Water and steam systems ispe international society for. Pharmaceutical engineering, ispe, novemberdecember 20, vol. This guide was produced by a dedicated team of subject matter experts from across the industry. This guide provides indepth guidance for the design, construction, operation, and lifecycle management of water and steam systems.
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