Blood Glucose Monitoring Systems: Cleaning & Disinfection Procedure Validation

Blood Glucose Monitoring Systems: Cleaning & Disinfection Procedure Validation

BioScience Laboratories Inc. conducts the FDA required validation of cleaning and disinfection procedures.  Each evaluation will include the following FDA requirements:

  • Selection of an EPA approved registered cleaning and disinfection product that does not result in the physical deterioration of the device overall, or deterioration of any device component as the housing or touch pad buttons.
  • Demonstration using the standard ASTM E 1053 and ASTM E2362 tests that the disinfection protocol is effective against Hepatitis B virus.
  • Demonstration that the Blood Glucose Monitoring Systems (BGMS) is robust to cleaning and disinfection procedures after multiple cleaning and disinfection cycles.
  • Description of how the cleaning and disinfection procedures affect the port of the meter.
  • Confirmation that the disinfectant does not cloud the face/display of the meter and does not corrode or erode the plastic housing or buttons.
  • GLP Protocol with acceptance criteria.
Labs
Methods
Industries

Virology Laboratory

BioScience Laboratories assists clients with new product development, R&D projects, marketing claims, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabilities with over 23 years of experience in conducting GLP and GCP compliant studies, we can offer a start-to-finish solution. Our personnel lead by Dr. Volha Teagle…

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ASTM - E2362

Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection

This test method may be used to determine if a pre-saturated or impregnated towelette demonstrates antimicrobial effectiveness as a disinfectant on hard surfaces. 

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ASTM- E1053

Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Non-porous Environmental Surfaces

This test method is used to evaluate the virucidal efficacy of liquid, aerosol, or trigger-spray microbicides intended for use on inanimate, nonporous environmental surfaces.

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Commercial / Professional Products

We have the knowledge base, equipment and experience to test your products for safety and efficacy to meet the global market. Serving such areas as food contact/non-food contact sanitizers and antimicrobial fabrics to name a few. We also offer a wide variety of safety testing in our in-vitro labs to…

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Personal Care Products

We serve clients from around the world who contract us to perform investigative studies on a wide range of personal care products. Standard, validated protocols have been developed to substantiate a wide variety of personal care product claims as well as claims for prescription and over-the-counter drug products. Specialized testing for these…

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