GE Analytical Instruments Manufacturing Facility Receives ISO Accreditations

Measuring the levels of total organic carbon (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, a division of GE Water & Process Technologies, has announced that its Boulder, Colorado, facility that manufacturers its Sievers* TOC Analyzers and corresponding consumables recently received the highest combined accreditation standard in the industry for its reference material production.

The new ISO Guide 34 and ISO/IEC 17025 certifications ensure manufactured reference materials are consistently produced, controlled and audited to robust quality standards. 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 GE’s 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.

"Supporting our Sievers TOC Analyzers with ISO Guide 34 and ISO/IEC 17025 certified standards helps further strengthen the complete solution that we provide to our customers in the pharmaceutical and other highly regulated industries," said Thomas Buer, general manager, Analytical Instruments—GE Water & Process Technologies.

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 the new ISO accreditations, the Boulder plant can further meet pharmaceutical customers’ GMP traceability requirements.