Hand Sanitizer Efficacy Testing

Our testing covers the full spectrum of hand sanitizer products and materials, from raw ingredients through finished formulations. Testing encompasses liquid and gel sanitizers, pre-saturated towelettes, and raw materials including ethanol and IPA. Our comprehensive approach supports standard formulations, specialized products, and additional requirements for specific use cases. We deliver detailed composition analysis and efficacy verification for each product type. 

• Complete formulation analysis 

• Raw material verification 

• Specialized product assessment 

• Full composition verification 

• Efficacy confirmation testing 

Access a complete verification suite featuring USP 611 Method II alcohol determination by GC-FID, which is required for all hand sanitizers in production to meet regulatory requirements. Our detailed component analysis via GC-MS and thorough chemical analysis against USP monographs confirms the raw materials in your product meet FDA guidelines for use in manufacturing hand sanitizers. Our extensive antimicrobial testing program covers efficacy verification, bacterial identification, endotoxin testing, and specialized virucidal claim support, meeting global regulatory standards and market requirements. 

• GC-FID alcohol determination 

• GC-MS component analysis 

• USP monograph verification 

• Antimicrobial efficacy testing 

• Virucidal effectiveness studies 

• COVID-19 specific testing 

• Bacterial identification 

• Endotoxin assessment 

Virology testing services: 

Element’s comprehensive virucidal testing services meet submission requirements for regulatory bodies worldwide. Our scientists possess years of virology experience, working with various viruses and methods to provide clients with high-quality results in a timely fashion.  

Antimicrobial Testing Services: 

Our antimicrobial efficacy testing services extend to pre-saturated towelettes and include the following tests: 

• Antimicrobial properties evaluation 

• Bacteria and mold identification 

• Bacterial endotoxin 

• Bacteriostasis and fungistasis 

• Bioburden/microbial enumeration test 

• Biological indicators (BIs) for sterility 

• Container closure studies 

• Media incubation and growth promotion 

• Microbial bactericidal concentration (MBC) 

• Microbial inhibitory concentration (MIC) 

• Microbial limits/enumeration test 

• Particulate analysis per USP 

• Sterility testing – including rapid sterility 

• Water sampling and testing 

Experience advanced testing methodologies combining precision and efficiency through optimized direct sample matrix analysis, which allows our experts to determine your disinfectant's efficacy without extensive sample preparation requirements. Our solutions range from basic alcohol content verification to complex virucidal efficacy assessment, supporting comprehensive pathogen claims with expedited testing services for all hand sanitizer efficacy testing needs. We provide specialized testing for varied formulation types and comprehensive documentation for market release. 

• Direct sample analysis methods that reduce preparation requirements 

• Optimized testing protocols 

• Global submission support 

• Expedited testing options for time-sensitive products 

• Specialized pathogen protocols, including COVID-19 

Virology testing services:  

Our virology testing services include testing high-level disinfectants, liquid chemical sterilants, and sporicides. Additional services include virucidal efficacy testing using the following methods: 

• ASTM E1053 Test Method for Efficacy of Virucidal Agents Intended for Inanimate Surface 

- Modified for formulation type – Water-soluble liquids/powders, spray products, pre-saturated towelettes 
- This test is necessary for EPA claims submission 

• ASTM E1052 Standard Practice to Assess the Activity of Microbiocides against Viruses in Suspension 

• EN 14476 Quantitative Suspension Test for the Evaluation of Virucidal Activity in the Medical Area 

Our laboratory utilizes state-of-the-art analytical instruments including advanced GC-FID and GC-MS systems for precise component analysis. These technologies, combined with specialized antimicrobial and virological testing equipment, deliver accurate results while minimizing sample preparation requirements and accelerating testing timelines. Our GC-FID technology helps determine if alcohol content will effectively kill pathogens/bacteria, while supporting both standard and specialized testing protocols across all product types. 

Our Santa Fe Springs facility delivers specialized chemical analysis of ethanol and IPA against USP monograph specifications. This laboratory focuses on FDA-compliant raw material verification and finished product testing. Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find out where your nearest Life Sciences hub is on our Locations Page. 

Navigate complex regulatory requirements with testing programs aligned to FDA, CDC, and WHO standards while supporting international market access. Receive comprehensive documentation and testing data suitable for global submissions, with expertise spanning US and international standards including USP, ASTM, and EN methodologies. We offer expedited services for time-sensitive testing needs, with support covering the complete regulatory landscape for hand sanitizer products.