Honeyman Group

Pharmaceutical Water Systems: Principles in Practice

Pharmaceutical Water: What's all the fuss about?

There’s a lot of complacency about water. Even in the domestic situation, few people in the developed Western World think much about it – until it isn’t there. Then you can’t drink it, wash in it, shower, take a bath, water the garden, clean the car, clean windows etc. A couple of days without water and suddenly it's the most important thing in life. The same is true in the pharmaceutical manufacturing environment. Water normally flows like manna from heaven to manufacture products, make up solutions, wash equipment, clean down areas etc. But no pharmaceutical facility would stay in production very long without it - water is truly a 'critical utility'. Being without water has consequences in any situation, but there are two crucial differences between water used for domestic purposes and that for pharmaceutical manufacturing - Quality and Cost

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’ plumbingsystem – 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 contaminations everywhere – it can spread throughout the facility instantly. So you can’t easily ‘test quality in’ to a working water system, which mean a total (holistic) approach to quality is needed; ie 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. 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 todays standards can be explained, and plenty of guidance and advice on the do's and don't of water systems will be on offer.

Optional: Teesside University Accreditation Assessment is an option is a bolt-on for this course – click here for more info