How do we normally sterilize hyaluronic acid PFS ? Fedegari presented the results of its last R&D study on terminal sterilization of Hyaluronic acid pre-filled syringes last October, during the “PDA UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES” on Huntington Beach, CA. The poster presentation showing an innovative way to overcome the challenging treatment of PFS with Hyaluronic acid solutions received the attention of visitors due to its relevance for the pharmaceutical industry.
Since many Rheological studies demonstrate that Hyaluronic acid solutions degrade and suffer molecular change when exposed to high temperatures, the thermal sterilization of pre-filled syringes containing HA has been a complex issue to be solved in the pursuit of cost-effectiveness in drug manufacturing.
Moist-heat sterilization cycles and viscosity analysis
We are now happy to share the results of this study, developed in collaboration with the IBSA Farmaceutici Italy and Amphenol (Kaye), in a white paper that describes the test details on the moist-heat sterilization cycles used, process equipment and viscosity analysis carried out by IBSA laboratories.
Here below you can find the abstract of the article:
An innovative way to thermally sterilize Hyaluronic acid PFS
“Several reports on degradation of HA involving microwaves, UV or γ-rays have been published. Rheological studies also show that HA solutions degrade at high temperature: viscosity of the solutions decreases in time as a function of temperature. Therefore, the thermal sterilization treatment of HA solutions represents a great challenge. An optimized moist-heat sterilization cycle can minimize product degradation (and change of molecular weight) maintaining the required viscosity for the specific application.”
Additional technical details about trials and cycles can be provided by Fedegari R&D department upon request.