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System cleaning validation process

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BIOLAB, trading as Thermo Fisher Scientific has introduced the Kaye Validator ITMS, 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 provides significant gains in production line utilisation and capacity.

Using proprietary ion trap mobility spectrometry, the Kaye Validator ITMS analyses swab samples for the presence of small molecule API residues and cleaning agents in seconds.

Sensitive to pico-gram detection levels, yet simple to operate and requiring minimal consumables, the Kaye Validator ITMS brings new efficiency to cleaning validation.

The system is backed by a comprehensive one-year warranty that includes software upgrades, and is supported by fully validated hardware, software, and firmware documentation

Features and benefits

* Proprietary ion trap technology for high sensitivity - user programmable to pico-gram detection levels.

* Rapid sample analysis time (approximately 10 seconds).

* Portable design for at-line use.

* Minimal operator training required.

* Low sample analysis cost.

* Self-calibrating.

* Rapid method development.

* Minimal consumable costs.

* Increased capacity utilisation and productivity-by minimising equipment downtime attributed to waiting for traditional analytical lab test results.

* Increased profitability-by effectively increasing installed capacity, and significantly reducing sample analysis cost.

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