The Value of a Manufacturer’s Pure Water Service Plan

From research to manufacturing, the most commonly used reagent in the biopharmaceutical environment is purified water. Whether it is for a few hours or a few days, downtime can cost companies millions of dollars in lost manufacturing capacity and research time. To avoid these costs, a maintenance and support plan for purified water systems is essential for any facility.

Although relatively simple to operate, today’s pure water systems incorporate complex purification and monitoring technologies to ensure the systems meet user and regulatory requirements. All such systems require regular maintenance to optimize reliability and water quality and to ensure a long life span. Poorly maintained water systems affect quality in biotechnology organizations at every level. Water that fails to meet user specifications, for example, with respect to undetected organic breakthrough or bacterial buildup, can result in lost productivity; in manufacturing settings, this can mean ruined batches or loss of valuable material.

The sophisticated monitoring and control capabilities of today’s water purification systems require that they be maintained by an engineer who is proficient in mechanical, chemical, and electrical systems. Few organizations have access to in-house experts who possess this breadth of capabilities coupled with specific system knowledge. Since maintaining a water system generally does not fall within the core expertise of biotechnology companies, a contract providing access to the vendor’s service engineers makes sense for most end users.

Choosing a maintenance plan

Experience, extent of service, familiarity with one’s specific water system, professionalism, and reactivity are the most important factors in selecting a maintenance service provider. Improper or unauthorized service can adversely affect the performance of the water purification system in addition to being a breach of the manufacturer’s warranty.

Best-in-class plans include full documentation of preventive maintenance, meter calibration while permitting (if necessary) system qualification, and U.S. Pharmacopeia (USP) suitability testing to meet current and/or future users’ needs. Timely response and global reach are essential for reducing downtime and minimizing the impact of system failure.

Water system manufacturers enjoy the most comprehensive access to parts, system engineering, and knowledge of maintenance and operation. A manufacturer’s access to consumables and testing equipment ensures complete, seamless support. Another benefit of manufacturer service providers is a clear path to upgrading and easily expanding water systems to meet the needs of growing companies.

Millipore Corp. (Billerica, MA) offers a total service package for its entire range of water purification systems. This service includes regular preventive maintenance visits, cartridge changes, electromechanical system checks, software system checks, and a complete inspection of critical components such as pumps and filter housings. All work is documented thoroughly for system performance, testing, and maintenance (Figures 1 and 2).

Figure 1 - Trained service engineers performing a routine validation check on a laboratory system.

Figure 2 - Experienced laboratory technician conducting preventive maintenance on a large system.

In addition to standard service contracts, the company also offers extended warranties for most of its systems. Extended warranties can be purchased as part of a service contract and cover all electrical and mechanical components of the system for repair or replacement at no additional charge to the customer. Other services include USP suitability testing and calibration services of the total organic carbon (TOC) and resistivity monitors.

Detailed qualification workbooks are available for the majority of the laboratory and all central purification and storage equipment. The qualifications include Installation Qualification (IQ), Operational Qualification (OQ), and preventive maintenance procedures as well as a suggested Performance Qualification (PQ) plan. For the past eight years, Millipore has qualified systems at 19 of the 20 largest pharmaceutical companies in the world. The qualification workbooks are designed for the systems and are executed by trained engineers. The cost can be a small fraction of what a private validation consultant would charge.

Additional benefits

While the primary goal of water system maintenance is to prevent interruptions in pure water supply, comprehensive service agreements offer substantial regulatory benefits as well. Since biopharmaceutical operations fall under multiple regulatory guidelines (GMP, GLP, U.S. EPA, and OSHA), a service provider should offer full documentation for operation, installation, and qualification, and compliance with all relevant regulations.

Maintenance service documentation must comply with the appropriate regulations for each industry. For water systems, this means system design, manufacturing process, quality controls, traceability, documented evidence, training for users and service personnel, support for periodic maintenance, qualification, and requalification considerations.

Although responsibility for complying with water system standards rests with the end user, a comprehensive validation and qualification service can save companies time and money in both the near- and long-term. Particularly in current Good Manufacturing Practices (cGMP) settings, proper maintenance and performance documentation can save time and money for water system validation.

Conclusion

For the past two decades, biopharmaceutical companies have evolved into specialty organizations that concentrate on core competencies such as target identification, fermentation, cell culture, and clinical development. Today, more and more organizations entrust manufacturers with vital activities such as water system maintenance and qualification. Working with a manufacturer provides access to essential knowledge and expertise when validating and maintaining important equipment. As a research-based company, Millipore offers a range of service plans for responding to the pure water needs of its biopharmaceutical users.

Mr. Rossi is Worldwide Service Product Manager, and Mr. Norris is Product Marketing Manager, Millipore Corp., Laboratory Water Div., 290 Concord Rd., Billerica, MA 01821, U.S.A.; tel.: 781-533-8662; fax: 781-533-3131; e-mail: [email protected]

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