EN 1500

The EN 1500 test simulates practical conditions to evaluate if hygienic hand rubs effectively eliminate transient microflora when used on artificially contaminated hands of volunteers.

The test applies to hand rub products used in hospitals, community medical facilities, dental settings, clinics of schools, kindergartens, and nursing homes.

The test takes 2-3 weeks to complete.

At Microbe Investigations, we perform the EN 1500 test using Escherichia coli (ATCC 8739). Additional strains can be added upon customer’s request.

This test is a European standard specifically developed for hygienic hand rubs. Unlike other tests focusing on different pathogens or conditions, this test quantifies the log reduction of transient microbial flora on hands under simulated real-life conditions. EN 1500 is unique as it involves human volunteers, ensuring effective performance in actual usage scenarios.

To pass, a hand sanitizer must demonstrate a statistically significant reduction in microbial flora comparable to a reference solution of 60% propan-2-ol, achieving effectiveness under the test conditions.

Prioritizing EN 1500 compliance ensures the hand sanitizer effectively reduces transient microbial flora, providing high standards of hygiene and safety. Compliance enhances product credibility and marketability, particularly in the European market where this standard is widely recognized and trusted.

The test is primarily designed for alcohol-based hand rubs, the most commonly used hand sanitizers. While other formulations can be tested, they need comparison against the standard reference solution of 60% propan-2-ol, which may not always be relevant for non-alcohol-based products.

Testing should be conducted at the initial development and formulation stage. Re-testing may be necessary in case of substantial formulation changes or processes. Periodic testing ensures continuous compliance and effectiveness, especially during regulatory reviews or market audits.

Common reasons for failure include insufficient alcohol content, poor formulation, weak application method, or incorrect volume usage during testing. Production fluctuations or ineffective dispersion of active ingredients can also lead to failure.

The test is crucial in maintaining public health and hygiene, ensuring hand sanitizers effectively reduce microbial load on hands, consequently preventing infection spread. Products following this standard contribute to infection prevention in healthcare facilities, food processing industries, and public environments.

To prepare, ensure the product has the appropriate alcohol concentration (typically 60-95% ethanol or isopropanol). Conduct thorough pre-testing to verify efficacy, adhere to precise formulation and production standards, and consult experts in microbiological testing. Conducting pilot studies can help identify and rectify potential issues before formal testing.

Benefits include increased customer confidence, compliance with regulatory bodies, and competitive advantage. Certification assures regulatory agencies and customers of product effectiveness, leading to increased sales and market acceptance globally.

Sanitizer formulations with high alcohol content like 60%-95% ethanol or isopropanol are more likely to pass this test. Formulations which include skin conditioners and emollients can improve user compliance and effectiveness by ensuring the products are safe to use and do not cause any skin irritation on frequent usage.