Hatano Research Institute Center for Drug Safety

Hatano Research Institute Center for Food and Drug SafetyEstablished in 1970, mainly engaged in scientific research on food and medicine. The negative control material and positive control material developed and produced by the Food and Drug Safety Center of Hatano Research Institute are widely used in in vitro cytotoxicity experiments, and can meet the technical parameter requirements for the negative control material - high-density polyethylene in GB/T 16886.5 and ISO 10993.5 Medical Device Biological Evaluation - In vitro Cytotoxicity Experiment Standards.

The main component of the negative control material is high-density polyethylene, which has different product specifications and can be used for in vitro toxicity experiments and implantation experiments.

The main component of the positive control material is polyurethane film, and it also contains different contents of ZDEC and ZDBC, which are used to simulate moderate and mild cytotoxicity, respectively. Positive control materials are divided into different product specifications and can be used for the development of in vitro cytotoxicity and implantation experiments.

The negative and positive control materials developed and produced by the Hatano Institute's Center for Food and Drug Safety have the characteristics of good batch reproducibility, stable performance, and rich specifications, and can be used as control materials for biological evaluation of medical devices - in vitro cytotoxicity testing.