InSpec™ DE is a sterile, ready-to-use disinfectant. It is a 70% v/v solution of denatured ethanol (TSDA 7) in WFI quality water.
InSpec™ DE is manufactured in accordance with GMP in an ISO 6 cleanroom. The product is filled and sealed in an ISO class 5 environment.
The solution is filtered through a 0.2 micron filter and gamma irradiated (at 25-45kGy) in a validated process to give a sterility assurance level SAL of 10-6.
InSpec™ DE is supplied with Certificates of Conformity, the Analysis and Sterile versions also have Irradiation Sterility and Endotoxin certificates.