- Swiss testing laboratory
Hand Sanitizer Testing Laboratory
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Abstract
Hand sanitizers are foam or gel-based formulations that aim to reduce or completely eliminate pathogenic microorganisms on hands. Sometimes referred to as hand antiseptics or hand rubs, these products are categorized as biocidal products and must undergo rigorous hand sanitizer efficacy testing to ensure their efficacy and safety before they can be approved for market release.
Hand sanitizer testing covers the evaluation of the product’s antimicrobial efficacy against selected pathogens, including bacteria and viruses using standardized methods. Besides antimicrobial tests, residual activity and rapid action time tests can also be performed based on regulatory requirements.
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Hand sanitizer testing on finished product
Hand sanitizers are generally considered finished products and must comply with relevant regulatory requirements to get market approvals. Regulatory requirements differ depending on which region the product will be marketed in. Hence, manufacturers are advised to consider the applicable safety and quality standards for each area before undertaking the test services. At MIS, we provide hand sanitizer testing services in compliance with European standards which are globally accepted.
Frequently performed hand sanitizer efficacy test methods at MIS
Several standard methods are available for testing the efficacy of hand sanitizer products.
Antibacterial testing for hand sanitizers and disinfectants
- EN 13727 – EN 13727 test method is designed to assess the bactericidal activity of chemical disinfectants used in the medical area. This standard is applicable to a multitude of disinfectant products like hygienic hand rub, hygienic handwash, surgical hand rub, surgical handwash, instrument disinfectants and surface disinfectants.
Antiviral testing for hand sanitizers and disinfectants
- EN 14476 – EN 14476 test method is a quantitative suspension test used for the evaluation of virucidal activity of sanitizers and disinfectants
- ASTM E1838 – ASTM E1838 standard outlines a test method to assess the effectiveness of handwash and hand rub product formulation in eliminating transient viruses from the skin.
Fungicidal or yeasticidal testing for hand sanitizers and disinfectants
EN 13624 – EN 13624 test standard is a quantitative suspension test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the medical area. This EN standard is applicable for both hand hygiene products and surface disinfectants.
Hand Sanitizer Efficacy Testing Requirements
Regulatory authorities provide standard protocols stating the test conditions and requirements that must be maintained during the evaluation of the efficacy of hand sanitizer products. Though these requirements may vary amongst standards, some conditions are generally applicable to all test methods. These considerations include:
- Mandatory test organisms
- Test temperature
- Contact time
- Interfering substances
- Log reduction in microbial count as a passing criteria
Microorganisms Used in Hand Sanitizer Testing at MIS
At MIS, we conduct hand sanitizer efficacy testing in accordance with mandatory test strains outlined in standard protocols. As part of our tailored services, customers have the flexibility to choose test strains based on their product types and intended use.
Bacterial strains
- Staphylococcus aureus (ATCC 6538P)
- Klebsiella pneumoniae (ATCC 4352)
- Escherichia coli (ATCC 8739)
- Legionella spp. (ATCC 700511)
- Salmonella enterica (ATCC 10708)
- Pseudomonas aeruginosa (ATCC 15442)
- Enterococcus hirae (ATCC 10541)
- MRSA (ATCC 3391)
Viral strains
- Human adenoviruses (ATCC VR-5)
- Vaccinia virus (ATCC VR-1549)
- Betacoronavirus 1 (OC 43) (ATCC VR-1558)
- Human coronavirus (229E) (ATCC VR-740)
- Influenza A virus (H3N2) (ATCC VR-1679)
- Influenza A virus (H1N1) (ATCC VR-1469)
- Feline calicivirus (FCV) F-9 (US Patent strain)
- Poliovirus Type 1 (Sabin) (LSc-2ab)
- Murine norovirus (MNV) (S99)
- SARS CoV-2
Fungal and yeast strains
- Aspergillus niger (ATCC 16888)
- Penicillium funiculosum (ATCC 11797)
- Chaetomium globosum (ATCC 6205)
- Aureobasidium pullulans (ATCC 15233)
- Candida auris (MYA5002)
Candida albicans (MTCC-3017)
Importance of hand sanitizer testing
1. Ensuring effectiveness
- Pathogen elimination: Hand sanitizer product testing confirms the product’s ability to kill or reduce harmful microorganisms such as bacteria, viruses and fungi.
- Public health protection: Hand sanitizers tested for effectiveness help prevent the spread of infectious diseases especially when soap and water are not readily available.
2. Consumer safety
- Ingredient safety: Testing ensures that the ingredients used in hand sanitizer formulations are safe for human use and do not cause adverse effects.
3. Regulatory compliance
- Meeting standards: Hand sanitizer product testing helps manufacturers comply with regulations set by bodies like the FDA, CDC and WHO. It ensures that products meet necessary safety and efficacy standards.
- Label accuracy: Testing ensures that claims made on product labels, such as “kills 99.9% of germs,” are accurate and supported by scientific evidence.
4. Quality control
- Batch consistency: Regular testing of production batches ensures that every batch of hand sanitizer maintains its efficacy and quality.
- Contaminant detection: Testing can identify any contaminants or impurities in the product thus ensuring only safe products reach consumers.
5. Product development
- Formulation improvement and innovation: Testing different formulations can help in developing new, more effective hand sanitizers.
6. Market competitiveness
- Consumer trust: Products that are rigorously tested and proven effective are more likely to gain consumer trust and loyalty.
- Brand reputation: Consistent product quality and efficacy help in building and maintaining a strong brand reputation.
7. Response to public health emergencies
- Pandemic preparedness: Regular testing of hand sanitizer products ensures that they are effective and can be used to prevent the spread of diseases during emergencies such as sudden disease outbreaks like the COVID-19 pandemic.
- Rapid deployment: Reliable testing allows for the quick approval and deployment of hand sanitizers in response to public health emergencies.
Why trust MIS with your hand sanitizer product testing?
Our hand sanitizer testing lab is well-equipped with the latest technology and equipment to analyze the antimicrobial strength of formulations. We also offer a comprehensive range of testing for surface disinfectants and antiseptic products.
Are you looking for hand sanitizer testing services? Contact us here for a thorough consultation from our experts.
Frequently Asked Questions
DR. Martinoz Scholtz
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