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We developed a prepacked mixing system for the preparation of bone cement. The system is based on mixing and collection of bone cement under a vacuum and serves as both the storage and mixing device for the cement components, thereby minimizing the exposure of the operating staff to the monomer and the risk for contamination of the cement during preparation. We evaluated the system using Palacos R and Simplex P. The cement produced was compared with cement obtained from a commercially available mixing system. Temperature evolution during curing, handling characteristics, density, and porosity of the cement obtained were analyzed. The results showed that the experimental system produces cement with physical properties (i.e., setting times and temperature, porosity, and density) equal to or better than those obtained with commercially available systems. Reducing the amount of monomer in the experimental system led to a reduction of the curing temperature without compromising the physical properties of the cements.

A proposed specification covering handling characteristics and physical and chemical properties of bone cement composed primarily of methyl methacrylate has been prepared on the basis of data from the authors' studies and from various other sources. Under handling characteristics, requirements included relate to dough, handling and setting time, proper plasticity for insertion and temperature rise on setting. Mechanical properties specified include compressive strength and indentation and recovery characteristics. Maximum limits are proposed for water sorption and solubility. Suggested packaging requirements are also included.