High Purity Water In the Spotlight: High Purity Water

Editor: Dr. Jörg Kempf

Many of the challenges faced in the pharmaceuticals industry cannot be solved with a simple telephone conversation. Instead, intensive discussions between manufacturers and users, as well as between government bodies and quality experts are the key. A new event concept will offer a platform for exchanging ideas and information relating to all aspects of high purity water.

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Requirements in the pharmaceuticals industry are becoming increasingly demanding. For example, ever more active ingredients in the development and production of pharmaceuticals are being classed as highly active or are of bio-pharmaceutical origin. When using these classes of substance, not only are there stringent product safety rules to contend with, but increasing requirements designed to protect the safety of workers also need to be taken into account.

In order to ensure that these measures remain within an acceptable financial framework, innovative and individually tailored solutions are needed. As far as production is concerned, the most important resource is high purity water, which is needed absolutely everywhere, whether for chemical analysis, rinsing containers or as a raw ingredient for solid or liquid products. Here, one of the key challenges is the monitoring of water quality. While the technical design of plants for the production of HPW, AP or WFI is already very advanced, focus is now shifting increasingly towards the raw water. As the need to cut costs has not been lost on the pharmaceuticals industry, there is a demand for ideas and concepts which will help to deliver frugal high purity water production. Beyond these concerns, service and reliability are the most important criteria when choosing suppliers.

The “Lounge” concept

The aspects mentioned above are only some of the challenges which will be discussed at the third Lounges event which will take place from March 17-19, 2009 at the exhibition center in Karlsruhe/Germany. This innovative concept for a trade exhibition is split into three areas: talks, the “Lounge” concept exhibition area and numerous action stages. The talks are divided into expert sessions and newcomer sessions. In these talks, the experts will once again offer answers to current issues in the world of high purity water, along with their views on five other topics. The innovative “Lounge” concept has proved a great success over the past two years, and event organizer Inspire is already expecting increased numbers of exhibitors and visitors for next year’s event (2008: 90 exhibitors, 3650 visitors).

Among other things, the talks and demonstrations will cover the areas of hygienic design for valves, pumps and containers, the use of materials, surfaces and lubricants as well as the current GMP rules and issues relating to certification, inspections and audits. Another important focal point of the event will be the subject of innovative buildings/facilities, new construction and conversion projects. This will also cover sterilization equipment and technology, sterilization techniques and containment systems.

In addition, there will also be talks on equipment for clean rooms, including clean room cleaning and disinfection, clothing and materials for clean rooms, consumable materials for clean rooms, plus ceiling/wall systems, floors, filtration systems and filters for suspended matter. This module is completed by contributions relating to water processing and issues around process water and high purity water, including WFI, PW, and HPW. In order to widen the range of visitors and exhibitors at next year’s event, in addition to the Clean Room and Water Lounge, there will also be a Facility Lounge and the HygieniCon, the GMP Lounge and a Processing Lounge on offer.

Joints for ultra-pure pipe components

The complexity of the topic of high purity water is underlined by the selection of products below which will be presented in the Lounges. The WNF welding technique was specially developed around 20 years ago in order to join together ultra-pure pipe components. These welded joints are free of tension, offer a homogeneous welding zone with very high mechanical strength, as well as excellent surface quality without refinishing of Ra < 0.25 mm. Thanks to the highly smooth inner surface of the welded joint, the technique offers beneficial properties in terms of microbial contamination, biofilms and cleaning behavior. With the WNF welding technique, the materials PVDF (polyvinyliden fluoride) and PP-n (natural polypropylene) can be welded without the formation of a welding bead.

Pharmaceuticals companies also need to stay flexible—and this applies to the production of high purity water as well. The Septron Line 100-300 from the Christ Water Technology Group goes a long way to meeting these requirements thanks to a compact design, maximized variability and the use of high-grade technology. The modular layout of the product line enables demand-driven configuration and expansion of individual plant components. Units for electrode deionization (EDI) and reverse osmosis (RO) can be combined and positioned independently of each other. The pre-certified VAL design meets the requirements of the pharmaceuticals industry. The Aqua Purificata produced with it exceeds all of the requirements of the European (Ph.Eur.) and American (USP) pharmacopoeias several times over. The highest microbiological purity is assured with dead spot-free connection technology.

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Preserving value

Plant and process data are an asset and hence represent a great value to companies. This also applies for example to water processing plants, in particular if they are part of the validation process in pharmaceuticals or biotechnology companies. The problem: the lifecycle of any planning software is limited. This is compounded by the fact that only modern CAD/CAE systems correspond to the state-of-the-art in terms of technology and meet the commercial requirements of the industry. They are more cost-effective and more powerful than the old systems. Consequently, a migration to modern systems is unavoidable. This does however leave the question how the non-visible capital can be migrated. As a practical example shows, this is possible with very small outlay: an operator wanted to migrate 1000 P&IDs from a Unix-CAD system to the Cadison engineering solution. Whereas a re-draw would take three days per P&ID, the migration to Cadison only took five minutes per P&ID plus a post-processing time of one hour. In this particular project, the customer saved 95 percent of the outlay that would have been associated with a traditional approach. In absolute terms, this corresponds to savings of around € 1 million for the user.

All of these examples show the breadth of the range of solutions on offer, so expect plenty of intensive discussions in the Lounges!

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