Disinfection Efficacy Testing (DET)

Gain complete confidence in your aseptic environment's safety with data-driven Disinfection Efficacy Testing (DET) services. Our experienced, consultative team will partner with you to ensure your critical cleanroom and controlled environments demand proven disinfection protocols that meet regulatory requirements. Get comprehensive testing tailored to your facility's unique surfaces and contaminants, with rapid turnaround times that keep your operations moving.

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What is Disinfection Efficacy Testing (DET) at Element?

Disinfectant Efficacy Testing formally evaluates how effectively disinfectants eliminate microorganisms and viruses on various surfaces within aseptic environments. At Element, our testing complies with USP <1072> as we provide comprehensive testing services that validate your disinfection protocols against both standard and facility-specific microorganisms, delivering the documented evidence needed for regulatory compliance.

Element life sciences testing expert in lab

What Can Element Offer You For Disinfection Efficacy Testing (DET)?

Key tests offered

We deliver a complete range of testing services to validate your disinfection protocols thoroughly. Our comprehensive testing approach combines standard USP methodologies with customized protocols designed specifically for your facility's needs, including testing against the USP standard organisms and contaminants isolated from your facility, providing you with robust validation data for all critical control points.

Core testing capabilities:

  • Disinfectant efficacy testing for bacteria and mold (vegetative and spore-forming)
  • Efficacy testing for antiviral activity
  • Custom kill-time studies
  • Recovery studies on facility surfaces
  • Neutralization validation
  • Suspension preparation for facility isolates

Range of services offered:

  • Guidance on DET study design
  • Customized study design
  • Custom methods – wet contact, wipe, mop
  • Development of robust disinfectant protocol
  • Recovery studies on custom surfaces
  • Neutralization of disinfectant
  • Efficacy studies – surface disinfectant organism vs. contact time
  • Customized suspension preparation for in-house isolates – recovered from facility
  • Kill time studies – dilution
  • Customized reporting

Components and materials we test

Your facility's success depends on effective disinfection across all critical surfaces. We provide comprehensive testing for every surface type in your controlled environment, from standard cleanroom materials to custom components. Our validation protocols cover the full spectrum of materials present in your facility, giving you complete confidence in your disinfection strategy.

Surface types we validate:

  • Standard cleanroom surfaces
  • Custom facility materials
  • Production equipment surfaces
  • Storage area materials
  • Transfer system components

Methods And Solutions Offered

Your disinfection protocols deserve validation that matches your real-world application methods. Our lab will test your chosen disinfectants using your disinfectant application methods, adapting our testing approach to mirror your facility's specific procedures, from contact times to application techniques. This ensures your validation data accurately reflects your operational practices and meets regulatory requirements.

Disinfectant Efficacy Testing for Bacteria and Mold (Vegetative & Spore-Forming)
Surfaces commonly found in GMP manufacturing facilities are inoculated with test bacteria and mold, including routine contaminants identified during production. These surfaces are then disinfected using the facility’s standard procedures. After treatment, surviving organisms are measured to determine the disinfectant’s effectiveness. The GMP facility sets the required reduction level for qualification testing.

Disinfectant Efficacy Testing for Antiviral Activity
GMP facility surfaces are inoculated with test viruses and any routine viral contaminants identified during manufacturing. The surfaces are then disinfected using the facility’s usual methods. After treatment, virus survival is assessed using a virus-specific assay. The GMP facility determines the necessary reduction level for effective disinfection.

Custom protocol development

We understand that disinfectant studies can be a bottleneck in getting your facility up and running with confidence. Our team works alongside you to develop comprehensive testing protocols that address your specific needs. With analysts devoted to disinfectant studies, we provide regular communication throughout the testing process, including notifications of any test failures. This collaborative approach results in robust disinfection strategies backed by thorough validation data that supports your contamination control program.

Which Labs Offer This Service

Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Standards we test to and components we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!
  • USP <1072> Disinfectants and Antiseptics
  • USP <51> Antimicrobial Effectiveness
  • USP <1227> Validation of Microbial Recovery from Pharmacopeial Articles

Your Challenges, Our Solutions

Streamlined regulatory compliance

Your facility needs documented evidence of disinfectant effectiveness for regulatory requirements. Our comprehensive testing protocols deliver detailed validation reports that satisfy regulatory standards while perfectly matching your specific facility needs, eliminating compliance concerns.

Accelerated validation process

Time-critical facility operations can't afford lengthy validation delays. Our dedicated analysts work on aggressive testing schedules with regular progress updates, helping you maintain operational momentum while receiving thorough, quality-driven results that support your timeline requirements.

Tailored testing solutions

Each facility presents unique contamination control challenges requiring specific solutions. We develop customized protocols that test your exact surfaces, organisms, and disinfection methods, providing relevant data that directly addresses your facility's particular needs and requirements.

Integrated contamination strategy

Managing multiple testing requirements creates unnecessary complexity and delays. Our all-in-one service can sample, isolate, identify, and harvest organisms for your DET in one place, combining in vitro testing, in situ environmental monitoring, and routine checks into a seamless program, streamlining your entire contamination control strategy.

Why Choose Element

Element scientist in white lab coat working in life sciences testing laboratory

Multi-level single testing partner

Access all levels of contamination control testing through one trusted provider, from in vitro efficacy testing to in situ environmental monitoring, simplifying your validation process

Rapid results delivery

Dedicated analysts and aggressive testing schedules keep your validation moving forward while maintaining quality standards

Custom protocol excellence

Tailored testing programs that match your facility's unique requirements and operational procedures

Global regulatory expertise

Comprehensive experience with EPA, Health Canada, TGA, European Chemicals Agency, and FDA requirements

30+
years

of antimicrobial testing expertise

#1
leading contract laboratory

for antimicrobial testing

3
key

standards we test to
Element laboratory scientist placing raw materials sample in test chamber for controlled testing conditions
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Speak to our team of experts

AMERICAS

Toll free from US lines

+1 888 786 7555

EUROPE

Contact our Central Team
UK

Freephone from UK

+44 808 234 1667

Germany

Freephone from Germany 

+49 800 000 5137

MIDDLE EAST

Toll free from UAE

+971 800 353 6368