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. With special technical solutions from HunterLab, the colour of liquid samples (even in very small quantities) is examined with the greatest accuracy.
In order to check the product quality of yellowish, almost colourless, liquid samples, 37 comparative solutions of the EP colour number were specially developed. These are used to determine the colour 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 pharmaceutical solutions. However, this visual method is very subjective, depends on the employee carrying out the comparison and is 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 colour in the three-dimensional L*, a*, b* colour space. Target colour values and colour standards that meet the strict requirements of the European Pharmacopoeia are integrated directly into the software.
Colour measurement in accordance with 21 CFR Part 11 is also possible with HunterLab colour measurement devices. This means that the requirements of the FDA can be complied with by means of electronic records (logs) and signatures.
In our latest HunterLab NEWS issue you can read more about colour measurement of very small quantities, EP colour number and validation & compliance or everything about colour measurement FDA-compliant according to 21 CFR Part 11 in our new white paper!
Whitepaper: “FDA-compliant colour measurement” & article: “Colour measurement of small quantities”
Read all about validation & compliance in colour measurement in our latest white paper and in the HunterLab NEWS magazine how to reliably measure very small, liquid sample quantities and what to look out for in terms of sample handling.
Please fill in the two fields below and we will send you the reading material as a PDF!
