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Temperature validation for refractometers is crucial to ensure temperature accuracy in pharmaceutical validation according to the latest release of USP Chapter 831.
Here’s why it’s important:
Accuracy of Refractive Index Measurements: Refractive index is a temperature sensitive property, and even small temperature variations can impact the Refractive Index measurement results. In the food industry, refractometers are often used for a single product and so it’s possible to minimize temperature inaccuracy by applying a temperature coefficient to the result. USP General Subchapter (831) is written to test temperature measurement control accuracy because each API, Solvent, or raw material will have it’s own unique temperature coefficient. So, applying a mathematical solution to all unique samples is impossible. Pharmaceutical labs measure many different products from solvents to syrups and correction factors will not work. The USP is aware of this phenomenon and has directed temperature measurement validation at 200C and 250C.
What has changed: Given the importance of temperature, the USP has changed the validation methodology. Before December 2023 validation of temperature was implied and it was enough to prove that the temperature was close enough not to cause major result errors. After December 2023 a lab must prove traceability of the refractometer temperature sensor in the same way that other measurement devices have to be validated.
How does Rudolph address USP 831 Temperature Validation for Refractometers used in Pharmaceutical Laboratories?
Rudolph Customers have 2 choices for Refractometer Temperature Validation.
Have Rudolph perform an annual Preventative Maintenance service that includes a full instrument validation. This will include a USP compliant temperature validation/check.
Customers may also elect to purchase a Rudolph, Refractometer Temperature validation kit. (=-$1,500 USD)
Rudolph has designed a USP 831 temperature validation kit to make it possible for users to perform temperature validation on-site. This solution is suitable for all refractometers manufactured since 2014
• Rudolph Refractometer instruments manufactured before 2014 can only be calibratable by Rudolph trained service technicians.
• Post 2014 and pre 2024 instruments can be calibrated by end users using the Rudolph temperature calibration package. If the instrument fails calibration, then it will probably need a Rudolph trained person to adjust it. • Post 2024 instruments will be both calibratable and adjustable in the field by users with the temperature calibration package. (Purchased as an option)
Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 • 973-584-1558
Fax: 973-584-5440 • Email: info@rudolphresearch.com • Internet: www.rudolphresearch.com
