By Grace Sey, James Curtis, Elizabeth Griffiths, and Abdul Ally
Working at cryogenic temperatures presents many challenges. One important element involves ensuring labels remain intact and securely adhered to packaging after application as product moves from ambient temperatures to cryogenic temperatures to thawing at the point of use. To address the stability and adhesion of four different label lots from three manufacturers, Fisher Clinical Services, a part of Thermo Fisher Scientific, designed a label evaluation study to observe how well each label type adhered to its substrate under conditions of application, cure time, thawing, and storage in cryogenic temperatures over a 5-month time period. This study serves as a model for the need to validate label stability and adherence and is an example of the many different types of validation studies we regularly conduct to mitigate risk for customers during all phases of an advanced therapy clinical trial.