Cleaning validation system

The Kaye Validator ITMS is a portable at-line 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 (HPLC and TOC), this instrument can provide gains in production line utilisation and capacity.

Using proprietary ion trap mobility spectrometry, the unit analyses swab samples for the presence of small molecule API residues and cleaning agents in seconds. It is sensitive to pico-gram detection levels, yet simple to operate and requiring minimal consumables.

Features include: rapid sample analysis time (approximately 10 s); portable design for at-line use; minimal operator training required; low sample analysis cost; self-calibrating; rapid method development; and minimal consumable costs.