A reactivated hydrogen peroxide catalyst was installed on a major filling line in Denmark. It addressed the observed catalyst capacity challenge and has remained in commercial production since installation. It is the first catalyst Catalyst Reactivate has returned to service on an active commercial line, and two more installations are in progress.
The installation is a high-capacity vial filling line equipped with an isolator. Reduced catalyst capacity had been observed after only a few months of use, affecting hydrogen peroxide removal during aeration.
Aeration times became prolonged and the cycle was no longer reproducible within its validated limits. Modern isolators with automatic H2O2 endpoint control extend aeration if the specified low H2O2 level is not reached within the validated cycle time. In this case, investigation pointed to reduced catalyst capacity as the cause of the extended aeration. Reaching the H2O2 endpoint after an extension does not, by itself, establish compliance with the validated cycle.
Catalyst Reactivate treated an existing catalyst for reuse. The reactivated unit, prepared for evaluation, was released to the production line under the site’s change control when the capacity issue arose.
Following installation, the reactivated catalyst addressed the observed capacity challenge. The unit remained in use on the line, providing a practical reference for catalyst reactivation in commercial production.
Performance on other installations must be assessed against their operating conditions and acceptance criteria.
Airborne metals were sampled on mixed cellulose ester (MCE) filters following ISO 15202-1 and analyzed by a validated sector-field ICP-MS (ICP-SFMS) method at an accredited laboratory. This assessment addressed potential release of metals from the treated catalyst and supported the quality review for reuse. Results were assessed against ICH Q3D(R2) limits for platinum and palladium. Conclusions are specific to the elements analyzed and the conditions tested.
As a preventive maintenance service, catalyst reactivation is carried out during the planned annual shutdown. Reactivation and performance testing help maintain consistent catalyst performance between service intervals and reduce the risk of unplanned production shutdowns caused by insufficient catalyst capacity. Reusing suitable catalysts can also extend their useful life and reduce replacement needs. Reactivated units are typically returned within days.
Want the technical background? Our white paper explains why automatic extension of aeration time is not sufficient evidence of a validated cycle. Read the summary and get the full paper.
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