D3T aims to clean up in verification testing market

By Gareth Macdonlad

- Last updated on GMT

Related tags: Verification and validation

D3 Technology hopes its new SERS-based cleaning verification test, that follows FDA guidelines, will prove attractive to drugmakers looking to expedite the cleaning process and cut downtime between production runs.

The procedure combines the firm’s Klarite substrate technology with SERS (Surface Enhanced Raman Spectroscopy) to create a method capable of detecting trace quantities of analytes, down to the parts per billion level.

In addition, all components in an analytical mixture can be detected simultaneously, overcoming the need to ‘search’ for contaminants. A robust calibration curve can be generated so that known analytes can be readily quantified.

Commenting on the development, Catteria Netti, director of technology at D3T, said: “With the new Klarite protocol, we can cut verification times from days to hours. This has a significant impact on production efficiency. The reduction in plant downtime will have a major cost saving benefit to manufacturers​.”

Dr Netti went on to say that cleaning verification and validation are very important procedures for the industry adding that: “FDA [Food and Drug Administration] guidelines for plant cleanliness are well established and must be closely adhered to​.”

She explained that currently, most companies rely on analysis by HPLC to verify that a plant is clean, which is a long-winded method that requires considerable sample preparation.

Netti continued: “In this application, researchers have shown that SERS offers the required specificity and sensitivity, but until the development of our Klarite substrate, reproducibility and ease of use remained elusive.

Now, Klarite offers, for the first time, a SERS substrate that is highly reproducible and manufactured to industrial standards using volume fabrication techniques. D3 Technologies has developed Klarite into an easy to use format that can be read using any Raman instrument.”

Related topics: Contract Manufacturing & Logistics, QA/QC

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