Disinfectant Efficacy Testing
SurePath DET™ Program for GMP Facilities
SurePath DET is a specialized in vitro testing service created to help pharmaceutical, biopharmaceutical (including cell and gene therapy) and medical device manufacturers validate disinfectants as part of a facility’s Contamination Control Strategy.
The SurePath DET program is delivered by an experienced team with the knowledge and proficiency to help overcome some of the more challenging aspects of DET, including study design, conducting the technique-sensitive steps, interpretation of results, and reporting.
SurePath DET is More Than Testing
We can guide the science-based development of your study protocol to minimize unnecessary testing, expenses and delays while meeting regulatory expectations.
Through our SurePath DET program, STERIS provides comprehensive services for executing DET studies, including guidance on:
- Developing a study matrix
- Establishing disinfectant wet contact times
- Creating and procuring representative surface coupons
- Surfaces and/or organisms to include in the study
- Developing robust disinfectant efficacy testing protocols
STERIS’s SurePath DET program adheres to global regulatory standards to ensure your study is compliant.
SurePath DET Puts You on the Right Track
SurePath DET is the first among three essential components of a complete disinfectant validation.
In Vitro Efficacy Testing – SurePath DET
The purpose of SurePath DET in vitro efficacy testing is to evaluate if the chosen biocides are effective against environmental isolates (bacteria, fungi and spores) on representative cleanroom surfaces. We use test conditions that mimic your facility’s standard operating procedures, including water quality, use-dilution hold times, and exposure time and temperature.
In Situ Testing
In situ field studies demonstrate the ability of disinfectants to reduce and control microorganisms by conducting monitoring of your environment before and after the application of a disinfectant under worst-case conditions of expected microbial levels (e.g., a classified area planned shutdown, construction events, maintenance, etc.). In situ studies generate data that demonstrate the effectiveness of your Contamination Control Strategy, including application method. We can offer guidance for the development and execution of in situ testing in your facility.
Environmental Monitoring
Ongoing environmental monitoring (EM) provides continual assessment of the effectiveness of your facility’s Contamination Control Strategy. Tracking and trending EM data gives assurance that your program remains in a state of control. It can also serve as an indicator that your facility is experiencing shifts in flora that should be evaluated for potential risk to your state of microbial control.
We’re Here for You
Disinfectant validation can be a challenging process. SurePath DET provides the essential support and comprehensive testing results to position you for successful completion of your validation program.
Contact us today to discover how your facility can utilize the SurePath DET program to optimize your testing and maintain compliance.
Request SurePath DET Services