A faster pace for cleaning validation

Published: 17-Oct-2005


US-based GE Industrial Sensing has launched the Kaye Validator ITMS, a portable instrument for accelerating the cleaning validation process.

Operators can assess system cleanliness at-line with no delay, and get production lines up and running quickly. As an alternative to traditional analytical techniques such as HPLC, the instrument is said to provide significant gains in production line utilisation and capacity. Using proprietary ion trap mobility spectrometry, the system analyses swab samples for the presence of small molecule API residues and cleaning agents in seconds, is sensitive to pico-gram detection levels, and requires minimal consumables, according to GE. It is supported by fully validated hardware, software and firmware documentation. "The Validator ITMS verifies system cleanliness in seconds rather than hours," said Karen Huffman, manager of GE Sensing's healthcare business.

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