Antimicrobial Efficacy Test Method Hygienic Hand Rub & Hand Sanitizer (EN 1500, ASTM 2755)

The market for leave-on hand Sanitizers and hygienic hand rubs is a massive and highly competitive global category. To stand out and achieve regulatory compliance, manufacturers must provide robust scientific data substantiating the efficacy of their formulations. Eurofins CRL provides critical efficacy testing services according to the primary European and U.S. standards, ensuring your product is supported by the data required for market success.

EN 1500: The European Gold Standard for Hygienic Hand Rub

Purpose

The EN 1500 standard is the definitive European antimicrobial efficacy test method for evaluating the efficacy of leave-on hygienic hand rub products, such as alcohol-based hand Sanitizer. It is a phase 2, step 2 test conducted on human volunteers and is a mandatory requirement for products making hygienic hand disinfection claims in the EU market.

Methodology

The EN 1500 procedure is designed to determine if a test product is as effective as a proven reference antiseptic. The methodology involves a larger cohort of 18 to 22 volunteers and follows a precise protocol :

1. Contamination: Volunteers' hands are artificially contaminated with the test organism, Escherichia coli K12.
2. Baseline & Product Use: Pre-treatment ("prevalue") samples are taken. Volunteers then apply the test product or the reference product according to a standardised 6-step hand rub technique for a specified duration (e.g., 30 or 60 seconds).
3. Reference Product: The reference product is a 60% v/v propan-2-ol (isopropyl alcohol) solution, which serves as the benchmark for efficacy.
4. Performance Criterion: The performance criterion for EN 1500 is non-inferiority. The antimicrobial efficacy test product's mean log reduction of bacteria must not be statistically significantly less than the mean log reduction achieved by the 60% propan-2-ol reference product.

ASTM 2755: The Standard for U.S. Healthcare Hand Rubs

Purpose

The ASTM 2755 standard is an internationally recognised antimicrobial efficacy test method developed specifically for evaluating healthcare personnel hand rub formulations. Unlike ASTM 1174, which is designed for rinse-off products, ASTM 2755 focuses on leave-on formulations that dry without a water rinse. This makes it essential for the U.S. hand Sanitizer market, where regulatory submissions require robust data proving product effectiveness.

Key Feature: Single and Multiple Application Cycles

• Single and Multiple Application Cycles – The ASTM 2755 standard measures antimicrobial activity after both a single use and repeated applications.
• Real-World Simulation – Multiple-application cycles replicate how healthcare professionals use hand rubs throughout a workday.
• Ingredient Build-Up Analysis – Evaluates whether non-volatile ingredients (e.g., emollients, gelling agents) accumulate on the skin and reduce antimicrobial performance.
• Accurate Clinical Assessment – Provides a realistic evaluation of a product’s antimicrobial efficacy in clinical settings.
• Regulatory Compliance – Ensures manufacturers meet strict regulatory expectations while strengthening product claims for U.S. hand Sanitizer market approval.

FAQs 

Q1: What is an antimicrobial efficacy test method?

An antimicrobial efficacy test method evaluates how well a product reduces or eliminates microorganisms under standardised conditions. This ensures your product meets strict regulatory and safety requirements.

Q2: Why is non-inferiority important in EN 1500 testing?

Non-inferiority ensures that the test product is not significantly less effective than the reference antiseptic, confirming regulatory compliance. It helps validate product claims and supports EU market approval.

Q3: What does ASTM 2755 measure in hand rub formulations?

ASTM 2755 is an antimicrobial efficacy test designed for leave-on hand rubs, measuring performance after single and multiple applications. This provides realistic data for healthcare usage and clinical settings.

Q4: How do EN 1500 and ASTM 2755 differ in their approach to testing?

EN 1500 is a comparative test that evaluates whether a hand rub is at least as effective as a reference alcohol-based formulation (60% propan-2-ol), focusing on hygienic hand disinfection claims within the EU. In contrast, ASTM 2755 is designed for the U.S. market and assesses both single and repeated applications of leave-on hand rubs, simulating real-world healthcare use.

Q5: Why are antimicrobial efficacy tests required for global submissions?

Regulatory bodies like the FDA and EU require antimicrobial efficacy tests to substantiate product claims and ensure market approval. Without these tests, products cannot enter competitive global markets.

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