BGMS Cleaning Validation (Hepatitis B per FDA requirements)

The Microbiotest Division of Microbac Laboratories, Inc. is now offering Cleaning Validation for Blood Glucose Monitoring Systems (BGMS) against Hepatitis B Virus and other blood-borne viruses per FDA requirements. The FDA, in response to a critical public safety risk concerning the threat of transmission of disease from shared use of BGMS, recently issued new viral testing requirements for manufacturers of blood glucose monitoring systems to ensure that adequate labeling and instructions for use are provided to healthcare workers.  The Microbiotest Division of Microbac Laboratories, Inc. offers fully GLP-compliant testing services per FDA requirements for regulatory submissions.

Guidance Documents:

ASTM standard E1053-97(Reapproved 2002), Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces.

ASTM standard E2362-09, Standard Practice for Evaluation of Pre-Saturated or Impregnated Towelettes for Hard Surface Disinfection.