In June 2026, MicroVal approved the renewal of the certificate for Soleris Commercial Sterility Testing Vials (NF 105), manufactured by Neogen Corporation.
The original validation study was conducted in 2022 in accordance with ISO 16140-2:2016. As part of the renewal process, additional statistical analyses of the sensitivity study and interlaboratory study (ILS) were performed to meet the requirements of ISO 16140-2:2016+A1:2024.
Since the design of the sensitivity study remained unchanged between the two versions of the standard, the original data could be reanalysed using the updated statistical approach specified in ISO 16140-2:2016+A1:2024.
The renewed certificate, registered under study number 2021LR100, is available on the Issued certificates page, together with the supporting validation report.