Humagen Optimizes Testing Procedures
on IVF Products

Each master lot of micropipet glass and Pasteur pipets is tested for toxicity in a one-cell mouse embryo assay (MEA). The percentage of embryos exposed to the micropipets or Pasteur pipets that develop to the blastocyst stage are compared to control embryos. 

The embryos are assessed at 96 hours of culture. The product is considered non-toxic if the percentage of blastocysts in the treated group is greater than or within 10% of the control group, and no visible contamination of the culture has occurred. The MEA is considered valid if 70% or more of the control embryos reach the blastocyst stage. Each master lot of micropipet glass and Pasteur pipets is also tested for endotoxin levels using the Limulus Amebocyte Lysate assay and must be less than 20 endotoxin units per device to pass.

In addition, independent laboratory tests of packaging, sterilization and expiration date validation are conducted on all products during design and upon changes to materials or production. Certificates of Analysis are sent with each lot of micropipets and Pasteur Pipets.