Whether preparing for a regulatory submission or responding to an audit finding, disinfectant validation ensures your cleaning agents are fit for purpose and that your facility is safe for production.

Maintaining effective microbial control is critical in GxP-regulated manufacturing environments, with the pharmaceutical, industrial, medical and veterinary industries attracting more and more attention from regulatory bodies like the MHRA, HPRA and FDA. But the steep learning curve associated with disinfectant testing can be extremely time consuming for those not fully familiar with the methods.

The Eurofins BioPharma Product Testing (BPT) network of laboratories provides disinfectant efficacy testing on a daily basis for many of our clients, and offers validation services to support compliance with global regulations, including those from the FDA, EMA, and other authorities.

Navigate this complex process with us

Testing is commonly required when facilities undergo construction, renovation, changes to cleaning procedures, or the introduction of new disinfectants. Standards of testing vary across ASTM, ISO, and EPA guidelines, and there is no harmonised global protocol.

Annex 1 regulations require all disinfectants to be validated 

Disinfectants must be validated under usage conditions to prove their effectiveness against current common microbial flora found in your facility. This means observing actual mechanical actions, contact times, surface materials, and hold times, and also calls for regular review and revalidation to confirm ongoing efficacy.

Eurofins BPT provides a structured, scientifically robust approach to disinfectant validation. We test across a wide variety of surface types (stainless steel, glass, plastic, etc.) and microorganisms relevant to your cleanroom classification including:

• Bacterial spores 
• Gram-positive and gram-negative bacteria
• Fungi and yeast
• Standard environmental isolates 

Ensuring real-world reliability with BS EN

Our experts employ BS EN methods to assess product efficacy in both clean and dirty conditions to simulate worst-case scenarios on disinfectants, including handwashes and handrubs using the specifically designed BS EN 1499 and BS EN 1500 tests.

We use the BS EN 14348 quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants for medical instruments, and BS EN 14204 for veterinary instruments, while BS EN 13623 is used to evaluate bactericidal activity against Legionella of chemical disinfectants for aqueous systems.

We fine-tune our test methods to your risk profile and contamination control strategy and can provide.

Phase 1: Study Design and Protocol Generation 
Phase 2: Surface Efficacy Studies 
Phase 3: Suspension-Efficacy Studies  
Phase 4: Use-Dilution Expiration Studies 
Custom study designs to meet site-specific needs 
GMP-compliant documentation for regulatory review

Cost and logistical burden can be a concern for large or multi-site operations. Whether you need testing for a new disinfectant, modified formulation, or periodic revalidation, Eurofins BPT will collaborate with you to scope scientifically sound studies that are cost-conscious, and balance precision with practicality.