Disinfection Efficacy Studies

Good Manufacturing Practice (GMP) regulations and FDA guidance require that  bio/pharmaceutical manufacturers must prove that harmful residues or organisms are properly removed during cleaning to predetermined safety levels, thus eliminating contamination of manufacturing equipment. Disinfectant tests are applied to give proof of the efficacy of the cleaning and disinfectant procedure is sufficient to remove or inactive microorganisms including bacteria, yeast, fungi, viruses, molds and mycoplasma. The disinfectant efficacy is required to be established before a new disinfectant can be enrolled in the market.

The test materials generally include:

1) Household and industrial disinfectants

2) Sporicides

3) Fungicides

4) Hand sanitizers

A disinfectant efficacy test includes three main testing parameters: chemical agent, test microorganisms, and typical facility surfaces. In addition, the disinfectant regimens for cleanrooms and isolators as well as other controlled areas are necessary to be validated for the manufacturing processes.

Both the AOAC Chapter 6 and the USP <1072> give out guidance for conducting disinfectant efficacy testing to evaluate a disinfectant against a panel of clinically significant microorganisms and spores. We recommend our clients to enroll in a disinfectant efficacy program when environmental monitoring data suggests a drift in commonly recovered environmental flora or an organism is resistant to current chemical disinfectants, in addition qualifying a new chemical agent, or changes occur to facilities which may increase the bioburden challenge beyond normal operating levels. The deficiency of a cleaning and disinfection validation may cause an FDA 183 warning letter for the possible release of an unsafe product.

Our Disinfection Efficacy Studies Service

• Develop Study Protocol

  Determine microorganisms, surfaces, disinfectants and treatment conditions for testing. The panel of organisms selected for this test may also vary from the sponsor's specific facilities. It includes but not limited to:

  • Gram-positive bacteria
  • Gram-negative bacteria
  • Fungi
  • Mold spores
  • Gram-positive spore-forming bacteria
• Conduct Standard Disinfection Procedure
• Perform Comprehensive Evaluation Studies
  • Residual studies for evaluation of the disinfectant remaining amount on the surface
  • Recovery studies for evaluation the capability to recover the organisms applied to the surfaces
  • Disinfectant Neutralization/Toxicity/Interference Studies
  • Surface-Disinfectant Efficacy Studies
  • Tube-efficacy studies for evaluation of disinfectant effectiveness in solution
  • Use-dilution expiration studies for verification of the effectiveness of the disinfectant up to and beyond the pre-determined expiration date

Our Advantages

• Rich experience in designing and conducting disinfectant studies using a wide range of organisms, surfaces and disinfectants
• Customized study protocols and specific methods depending on customer's individual project needs
• Streamlined test combinations to meet customer budgets, schedules and regulatory requirements

STEMart offers comprehensive disinfection efficacy studies in various standards. If you have additional questions about Disinfection Efficacy Studies or would like to find out more about our services, please feel free to contact us.