Pharmaceutical Water: What's all the fuss about?

Every pharmaceutical factory has to provide water of ‘controlled consistent quality’ for product manufacture and processing, and in most cases that involves a water purification system to generate the appropriate grade, and a storage and distribution system - effectively a ‘hygienic’ plumbing system - to get this purified water to the users. Most commonly, ‘Purified Water’ (PW) and ‘Water for Injections’ (WFI) are the bulk grades you would find in a pharmaceutical manufacturing environment, and these have strictly prescribed quality requirements in all the Pharmacoepias, along with one or two lesser-used qualities.

It costs a lot to install a pharmaceutical-grade water system, it also costs a lot to run it and to maintain it, to control and monitor it, week in and week out, and it even costs money to throw used water away whatever the grade. It costs even more if the water quality is bad, and production is stopped, or worse if products have to be discarded. So quality and cost are inextricably linked when it comes to pharmaceutical water.

Another problem with pharmaceutical water systems is they must be monitored and controlled. A micro sample can be taken at 11 o’clock, tested in the lab and everything found to be fine five days later when the results come through, but in actual fact, the system could have been contaminated at 1 minute past 11 and nobody would know until the next sample was taken. What’s more - the pipework passing through a facility can transmit water contamination everywhere - it can spread throughout the facility instantly. So you can’t easily ‘test quality in’ to a working water system, which means a total (holistic) approach to quality is needed; i.e. the system must be designed well, operated and maintained properly, and be adequately monitored and controlled. Regulators such as MHRA and FDA inspectors, of course, know this and are likely to ask probing questions at audit about water systems. They know that water is crucial and a potential risk to quality and manufacturing.

But do the people involved know and understand their water systems? Can we be confident that the water system is good and producing quality water in between the testing?

Honeyman Training courses highlight the key and essential points of designing, building, owning, and operating pharmaceutical water systems. The basic design of water purification, storage and distribution system elements will be outlined, with illustrated examples. Delegates from different backgrounds and disciplines such as Engineering QC/Microbiology, Validation, Plant and Production Operators will learn and understand the roles each plays in the management, maintenance, and control of water systems. Good communication and understanding between these areas is of course essential and key to efficient and successful water system performance.

Honeyman lecturers are seasoned professionals, with many years' experience in the field of pharmaceutical water. Their practical knowledge and experience enables them to host in-depth question and answer sessions, the history and background of today's standards can be explained, and plenty of guidance and advice on the do's and don'ts of water systems will be on offer.

Who Should Attend This Course?

This course has been well received for many years by personnel involved in the design, management, and operation of pharmaceutical and biopharmaceutical water systems from the following disciplines: Engineering, Quality Assurance, Microbiology, QC, Production, Operations, and high purity water SME’s.

Course Objectives

Key learning objectives of the course are:

• Understand the regulatory requirements, standards, and expectations for pharmaceutical water systems
• Understand how to design, build, validate and manage water systems cost-effectively
• Be able to compare different strategies for generation, pre-treatment, storage, and distribution of pharmaceutical-grade water and select the most appropriate for your application

Course Content

• Water Types, Specs Uses, and Applications
• Methods of Purification - Purified Water EP/USP
• Methods of Purification - Water for Injections EP/USP
• RO vs Distillation for WFI New EP Proposals
• The Purification Train and Pre-Treatments
• Storage and Distributions Systems
• Basic Microbiology of Water Systems
• Testing Requirements for Compendial Waters
• Biofilm & Control Strategies
• New Builds, the URS, and Water Projects
• Problems with Conventional Loops
• HydroGienic® 
• Rapid Methods for Monitoring of Water Systems
• Rouge
• Monitoring and Qualification of Systems

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