Pharmaceutical Water Systems: Principles in Practice
Pharmaceutical Water Systems: Principles in Practice
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’ 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 mean 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. 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.
Optional: Teesside University Accreditation Assessment is an optional bolt-on for this course – click here for more info
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.
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
- 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
- PW and WFI System Site Visit
- Basic Microbiology of Water Systems
- Testing Requirements for Compendial Waters
- Biofilm & Control Strategies
- New Builds, the URS and Water Projects
- Workshop Introduction, Groups and Welding Demonstration
- Problems with Conventional Loops
- Latest ISPE Baseline Guidelines
- Rapid Methods for Monitoring of Water Systems
- Workshop 2
- Monitoring and Qualification of Systems
Course Dates / Costs Description
Please see the table above for the dates of next courses and the costs.
Please note: Our online booking system works in £GBP. The € Euro price is a guide price only. The final € Euro amount payable online will be the current exchange rate of the £GBP amount.
If you wish to raise a purchase order or pay via any other means than Credit Card for a booking then these € Euro guide prices will prevail as being the booking cost despite any fluctuation in exchange rates.
Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.
Course Terms & Conditions
The Honeyman Group has trained thousands of people within the pharmaceutical industry. Our courses continue to remain popular because they provide delegates with a sound understanding of scientific principles in each technical area, complemented by interactive workshops, discussions, practical demonstrations and case studies to put these principles into practice.
All of our courses are delivered by experts who actively work within the pharmaceutical, biopharmaceutical and medical device industries, therefore, we will continue to share pragmatic current best practice advice to enable you to meet current GMP and regulatory expectations.
- Our speakers are active in the industry today and are able to provide up to the minute experiences and current best practice advice
- Accredited Specialist Training on selected courses in conjunction with Teesside University
- We can provide bespoke on site training, perfectly suited to deliver the most effective and relevant training
Read training testimonials from previous delegates and commissioning organisations.
1st AugustRouge in Pharmaceutical Water Systems
16th NovemberA strong case for HydroGienic®