Disinfectant Qualification Services

STERIS assists in the design and execution of in vitro efficacy studies and provides expert recommendations for the application of qualified disinfectants and sporicides.

Pharmaceutical, biotechnology, compounding pharmacy, and medical device companies often have controlled environments that require aseptic processing of components and products. To ensure that these aseptic areas are consistently maintained, a validated cleaning and disinfection process is required by U.S. and international regulatory authorities.

Establishment of a Current Good Manufacturing Practices (cGMP) compliant process requires that the disinfectants used are effective and demonstrate the required efficacy within their specific controlled environments.

A disinfectant validation is comprised of three parts: in vitro efficacy testing, in situ monitoring of the cleanroom environment before and after a disruptive event, and routine environmental monitoring and trending of recovered microorganisms. The goal of in vitro efficacy testing is to demonstrate that the chosen chemistries are effective against your environmental isolates on your representative cleanroom surfaces, using test conditions that mimic your standard operating procedures (water quality, presence of organic soil load if of concern due to the manufacturing process, use-dilution hold times, exposure time and exposure temperature).

STERIS Laboratories’ disinfectant qualification services will assist in designing your in vitro efficacy study, conduct your study, and provide recommendations for the application of your qualified disinfectants and sporicides.

Variables to consider for a disinfectant qualification:

  • Guidance documents
  • Organisms
  • Disinfectants/sporicides
  • Exposure temperature
  • Use dilution hold times
  • Surfaces
  • Exposure times
  • Organic soil load (If applicable)
  • Water quality
  • Timeframe for study completion

As part of the STERIS family, the Laboratories have access to the STERIS Life Sciences team of global experts in the areas of cleaning and disinfection chemistries, commonly used in the pharmaceutical and biopharmaceutical industries.

STERIS has decades of expertise and experience consulting with Customers, developing robust disinfectant efficacy testing protocols and implementing real-world procedures for effective use of disinfectants and sporicides.

Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.