Colorimetry and colour measurement according to GMP and FDA
In the production and development of biopharmaceutical products, the focus is on reliable solutions for determining the EP Colour number according to Ph. Eur. 2.2.2 instructed. HunterLab’s special technical solutions are used to examine the color of liquid samples (even in very small quantities) with the greatest accuracy.
In order to check the product quality of yellowish, almost colorless, liquid samples, 37 comparative solutions of the EP color number were specially developed. These are used to determine the color quality of liquid pharmaceutical products, concentrated liquid proteins or any liquid that tends to turn yellow due to its starting materials or during the process. Its value is therefore an indicator of the ageing or effectiveness of medicinal substances.
In many companies, visual comparison with the EP colour standards is still used to characterize the colour of liquid drug solutions. However, this visual method is very subjective, dependent on the employee carrying out the comparison and difficult to validate and document.
However, the process can be very easily replaced by a measuring technique using the Vista colorimeter. HunterLab devices can measure and display color in the three-dimensional L*, a*, b* color space. Target color values and color standards that meet the strict requirements of the European Pharmacopoeia are integrated directly into the software.
Color measurement in accordance with 21 CFR Part 11 is also possible with HunterLab color measurement devices. This means that the requirements of the FDA can be complied with by means of electronic records (logs) and signatures.
Read more about color measurement of very small quantities, EP color number and validation & compliance in our current HunterLab NEWS issue or everything about FDA-compliant color measurement according to 21 CFR Part 11 in our new whitepaper!
Whitepaper: “FDA-compliant color measurement” & Article: “Color measurement of very small quantities”
Read all about validation & compliance in color measurement in our latest white paper and how to reliably measure very small, liquid sample quantities and what to look out for in terms of sample handling in the HunterLab NEWS magazine.
Please fill in the two fields below and we will send you the reading material as a PDF!