Contract Radiation Crosslinking, Packaging and Gamma Sterilisation Service for UHMWPE Prostheses

Gammalink Medical has provided a radiation-crosslinking service to South African manufacturers and importers of implants since 1998.  The company has since expanded this service to include local orthopaedic surgeons who prefer imported implants, but who would also like to provide their patients with the benefits of the Gammalink crosslinking technology. As any UHMWPE implant can be treated post-manufacture with this process, the wear characteristics of imported implants can also be enhanced.

When required, Gammalink Medical also provides a contract service for the double packaging of crosslinked prostheses in an ultra pure nitrogen gas atmosphere and the subsequent gamma-radiation sterilisation of the prostheses through a local contract radiation facility of Synergy Sterilisation (South Africa).

These services are also provided to overseas manufacturers and suppliers of UHMWPE prostheses on a sub-contract basis employing standard courier services.  The lead time is generally about 25 working days and minimum quantities of 100 devices per consignment are required.  As the labelling of such devices is customised to be in line with current procedures of manufacturers, these can be decided upon by mutual agreement between Gammalink Medical and overseas manufacturers.

In order to uniquely distinguish UHMWPE prostheses crosslinked through the Gammalink process from other crosslinked prostheses in the market, Gammalink Medical attaches a label to the primary packaging of all such prostheses clearly stating: Gamma crosslinked by Gammalink. As Gammalink is a registered South African trade mark, the use thereof will protect the interests of our clients and ensure that the excellent clinical track record associated with the Gammalink process applies to their products. Crosslinked UHMWPE prostheses not carrying this unique label have not been treated through the Gammalink process!


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