How to ensure a reliable method deployment? An example with the In Vitro SPF Double Plate method
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Presented by: Florence POURADIER
OBJECTIVE:
While the in vivo measurement method of SPF (Sun Protection Factor) remains the gold standard and has recently been revised (ISO 24444:2019(Amd), FDA 2022 ongoing), industry and the photoprotection expert community continue their efforts to offer a reliable, robust and ethical alternative method.
Developed and supported by Cosmetics Europe, the Double Plate method is currently being worked on at the Committee Draft stage by the ISO experts of TC 217/WG7. Recently, Cosmetics Europe called on the entire industry to start familiarizing themselves with this method, the ongoing statistical characterization of which within the ALT-SPF Consortium could lead to publication as an ISO method in 2025. Previously, some methods published by ISO may have experienced interpretation problems during their implementation in test laboratories, so how can you be sure that this new method will be reliably deployed in the industry?
The purpose of this communication is to highlight the key steps in the process of appropriation of a new method, based on our experience on the In Vitro SPF Double Plate method.
METHODS:
The study involved 3 internal laboratories (France (reference center), US, Japan) as well as 6 voluntary external laboratories (France, Poland, Germany, Ireland). The approach, that was deployed, included support and validation in each of the following points:
RESULTS:
Each of the steps of this process proved to be crucial for the success of the implementation and the appropriation of the method. The approach has highlighted certain pitfalls or errors of interpretation encountered frequently and which would be likely to undermine the reliability of the results obtained.
With the rigorous implementation of these steps, the Double Plate method for in vitro measurement of the SPF proved to be easy to familiarize with and perform.
The data obtained in the framework of this study have helped to enrich the database previously acquired during the ring-tests set up by Cosmetics Europe and to strengthen the statistical analyses of characterization of the Double Plate method.
CONCLUSION:
This work made it possible to identify some critical points the understanding and mastery of which were not as obvious as expected, thus highlighting points of improvement in the formalization of the method. The approach implemented, which made it possible to identify these points, constitutes a robust process to ensure a perfect implementation of the SPF in vitro Double Plate method and the obtaining of reliable and sincere results.
While the in vivo measurement method of SPF (Sun Protection Factor) remains the gold standard and has recently been revised (ISO 24444:2019(Amd), FDA 2022 ongoing), industry and the photoprotection expert community continue their efforts to offer a reliable, robust and ethical alternative method.
Developed and supported by Cosmetics Europe, the Double Plate method is currently being worked on at the Committee Draft stage by the ISO experts of TC 217/WG7. Recently, Cosmetics Europe called on the entire industry to start familiarizing themselves with this method, the ongoing statistical characterization of which within the ALT-SPF Consortium could lead to publication as an ISO method in 2025. Previously, some methods published by ISO may have experienced interpretation problems during their implementation in test laboratories, so how can you be sure that this new method will be reliably deployed in the industry?
The purpose of this communication is to highlight the key steps in the process of appropriation of a new method, based on our experience on the In Vitro SPF Double Plate method.
METHODS:
The study involved 3 internal laboratories (France (reference center), US, Japan) as well as 6 voluntary external laboratories (France, Poland, Germany, Ireland). The approach, that was deployed, included support and validation in each of the following points:
- Suitability of equipment
- Mastery of practical implementation
- Validation of the results obtained on a set of 10 training formulae
- Management of standards
RESULTS:
Each of the steps of this process proved to be crucial for the success of the implementation and the appropriation of the method. The approach has highlighted certain pitfalls or errors of interpretation encountered frequently and which would be likely to undermine the reliability of the results obtained.
With the rigorous implementation of these steps, the Double Plate method for in vitro measurement of the SPF proved to be easy to familiarize with and perform.
The data obtained in the framework of this study have helped to enrich the database previously acquired during the ring-tests set up by Cosmetics Europe and to strengthen the statistical analyses of characterization of the Double Plate method.
CONCLUSION:
This work made it possible to identify some critical points the understanding and mastery of which were not as obvious as expected, thus highlighting points of improvement in the formalization of the method. The approach implemented, which made it possible to identify these points, constitutes a robust process to ensure a perfect implementation of the SPF in vitro Double Plate method and the obtaining of reliable and sincere results.