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A direct-contact cell-culture test method has been developed to provide routine lot-to-lot biological assurance as a part of the quality assurance program during the manufacture and distribution of medical materials and sterile-packaged human-implant devices. It is particularly useful for detecting trace ethylene oxide or catalyst residuals. The method has also been used routinely to provide a first biocompatibility evaluation of proposed new materials or formulation.
Specimens are placed in direct contact with human fibroblastic cells grown to a confluent monolayer. The results are evaluated microscopically after 24 h incubation, using appropriate positive and negative controls. An alteration in cellular morphology is considered a cytopathic effect (CPE). Implant materials and devices are approved by the quality assurance department only if they produce no CPE in this test.
This test method has been used continuously in the lot-to-lot quality assurance program at Dow Corning's Medical Products Plant for more than ten years and has provided a fast, reliable, highly sensitive, and inexpensive method for evaluation of biocompatibility.
tissue culture, direct contact, biocompatibility, cytopathic effect, medical devices, cell culture, cytotoxicity
Quality assurance biology laboratory supervisor, Dow Corning Corp., Midland, MI