The Safety of the Manufacturing Process

There is virtually no chance of contracting avian flu from SUPARTZ Joint Fluid Therapy. Even if there were some contamination of the source of the active ingredient, all contaminants would be completely inactivated in the processing due to the high processing temperature.

SUPARTZ Joint Fluid Therapy is an injection made from highly purified sodium hyaluronate extracted from rooster combs. These combs are harvested from roosters that have been certified as suitable for human consumption via pre- and post-mortem veterinary inspection.

The ability of the processing steps to inactivate/remove virus strains in selected processing stages, including robust heat treatment, was confirmed by a virus validation study.

The validation study was conducted at Charles River Laboratories Preclinical Services Edinburgh Ltd. (formerly Inveresk Research) Tranent, Edinburgh, Scotland, which is a global contract research organization. Their expertise in evaluating viral safety and conducting validation studies, using the most modern technology and techniques, is recognized worldwide.

The study was conducted with five different species of viruses possessing different physicochemical characteristics. These served as models for potential viral contaminants of avian derived material. Parainfluenza virus type 3 was selected as the model virus for the avian flu virus.

The results of the study indicated that all processing stages, including heat treatment, either rendered the parainfluenza virus type 3 inactive or removed it altogether. Furthermore, the remaining four virus species tested were overall effectively inactivated or removed via these processing steps.

According to the World Health Organization (WHO), the avian flu virus (H5N1) is rendered inactive when exposed to temperatures over 70°C (158°F).¹ The processing of SUPARTZ Joint Fluid Therapy includes stages where the temperature remains much higher than 70°C (158°F). Thus, the heat treatment process is sufficient to inactivate potential avian sourced viral contaminants.

The results of the study demonstrate that the processing steps ensure the safety of SUPARTZ Joint Fluid Therapy from viral contamination including avian flu virus. In conclusion we believe there is no risk of any active viral transmission from SUPARTZ Joint Fluid Therapy.