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Automated filling process for reference materials, Tatabanya, Hungary facility.

Analytical Instruments, a division of GE Water & Process Technologies, today announced that its Tatabanya, Hungary, facility that manufactures Sievers* Total Organic Carbon (TOC) Analyzers and corresponding consumables has begun production of its certified reference materials. In addition, the facility’s new ISO Guide 34 and ISO/IEC 17025 certifications ensure manufactured reference materials are consistently produced, controlled and audited to robust quality standards.

All reference materials have a limited shelf life due to the nature of their makeup. By extending production of ISO Guide 34 and ISO/IEC 17025-certified reference materials to Tatabanya, Analytical Instruments will be able to provide its European customers with reference materials much more quickly than before, which will ensure an increase in remaining shelf life. This also offers customers more flexibility and decreases risk since less shipping and handling of the standards is required.

As a reference material producer, the ISO Guide 34 accreditation confirms Analytical Instruments’ processes are of the highest quality to produce the most consistent standards. It also shows that its certificates of analysis comply with strict guidelines and include all contributing factors to uncertainty.

ISO/IEC 17025 certifies the reliability of the testing performed in conjunction with reference material production. This accreditation confirms Analytical Instruments’ ability to produce precise, accurate test and calibration data with the instruments used to qualify each production lot. In addition to the new accreditations, Analytical Instruments’ quality to its customers is further enhanced as one of the only accredited TOC-certified reference material producers that cleans its own vials used in standards production, which enables more closely controlled processes and full traceability.

“Expanding production of our accredited reference materials to Tatabanya improves our offerings to customers throughout Europe, the Middle East and Africa. They will benefit from decreased shipping times and a longer shelf life for their reference materials, while still receiving the same quality and level of support they have come to expect from Analytical Instruments,” said Thomas Buer, general manager, Analytical Instruments—GE Water & Process Technologies.

Measuring the levels of TOC in the water is an important step for pharmaceutical companies to control processes that are critical to their operations and comply with regulations. Analytical Instruments has thorough experience in the pharmaceutical industry and understands the TOC and conductivity measurement requirements of USP, EP, JP and other country-specific pharmacopeia regulations. Through its new ISO accreditations, the Tatabanya plant can further meet pharmaceutical customers’ GMP traceability requirements. The Tatabanya location also is the second Analytical Instruments manufacturing site worldwide to receive these prestigious ISO accreditations. Its Boulder, Colorado, facility received ISO Guide 34 and ISO/ICE 17025 certification in March 2017.

(Source: GE)

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