ASTM E1115 Surgical Hand Scrub Formulation Efficacy Testing
After single or many treatments with surgical hand scrub products, the ASTM E1115 test uses what is termed as glove juice sample procedures to determine the decrease of immediate and persistent germs on hands.
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- Overview
- Scope, Applications, and Benefits
- Test Process
- Specifications
- Instrumentation
- Results and Deliverables
Overview
ASTM E1115-11 is a standard test method for measuring surgical hand scrub formulations, designed to determine how effectively they eliminate skin bacteria both immediately after use and over several hours while wearing gloves, ensuring critical hygiene in surgical settings.
The main purpose of this test, ASTM E1115-11, is to quantify the reduction in skin microbial flora caused by surgical hand scrubs and to assess their immediate and antimicrobial effects. The scrubbing product’s capacity to offer quick bacterial reduction and a long-lasting antimicrobial effect—both essential for preventing surgical site infections—is evaluated in an in vivo test (using human participants).
Scope, Applications, and Benefits
Scope
ASTM E1115-11 defines procedures to measure the reduction of microbial flora on human hands using surgical scrub formulations under controlled conditions. It evaluates immediate, persistent, and cumulative antimicrobial effects after single or repeated applications.
- Measures reduction of resident and transient microbial flora on skin
- Evaluates immediate and persistent antimicrobial activity (up to 6 hours)
- Allows optional 3-hour and 5-day cumulative testing protocols
- Requires human subjects and microbiological expertise
- Ensures compliance with human subject safety regulations (21 CFR Parts 50 & 56)
Applications
- Validation of surgical hand scrub formulations
- Evaluation of antiseptic and antimicrobial handwash products
- Healthcare infection control product testing
- Comparative analysis of active antimicrobial ingredients
- Regulatory compliance and product claims substantiation
- Quality assurance in hygiene and personal care products
Benefits
- Provides standardized and reproducible antimicrobial efficacy evaluation
- Measures both immediate and long-term microbial reduction
- Supports regulatory approvals and product validation
- Enables comparison across different formulations
- Enhances infection control assurance in surgical environments
- Assesses cumulative antimicrobial performance over repeated use
Testing Process
Subject Selection
Select healthy volunteers with no recent antimicrobial exposure.
1Baseline Sampling
Collect their initial hand microbial counts.
2Product Application
Apply surgical hand scrub as per the specified time and dosage
3Data & Reporting
Calculate log reductions and report results.
4Technical Specifications
| Parameter | Details |
|---|---|
| Test Objective | Efficacy of surgical hand scrub formulations |
| Test Type | In vivo antimicrobial evaluation |
| Test Subjects | Human volunteers |
| Measurement | Log₁₀ microbial reduction |
| Sampling | Standard hand sampling method |
| Outcome | Quantitative efficacy data |
Instrumentation Used
- Handwashing station with controlled water flow
- Sterile gloves and sampling containers
- Microbiological culture media and Petri dishes
- Incubator for microbial growth
- Colony counter or magnification device
- Pipettes and dilution apparatus
- Data recording and analysis system
Results and Deliverables
- Log reduction values of microbial flora
- Immediate and persistent antimicrobial efficacy data
- Cumulative antimicrobial activity results
- Comparative formulation performance analysis
- Detailed microbiological test report
- Compliance documentation with ASTM E1115-11
Why Choose Infinita Lab for ASTM E1115-11?
Infinita Lab is a trusted USA-based testing laboratory offering ASTM E1115-11 testing services across an extensive network of accredited facilities across the USA.
Infinita Lab is built to serve the full spectrum of modern testing needs—across industries, materials, and methodologies. Our advanced equipment and expert professionals deliver highly accurate and prompt test results, helping businesses achieve quality compliance and product reliability.
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Frequently Asked Questions
ASTM E1115-11 evaluates how effectively surgical hand scrub formulations reduce microbial flora immediately after use and maintain antimicrobial activity over time, ensuring sustained protection and minimizing infection risks during surgical procedures.
Human skin provides realistic biological conditions, including natural flora and variability, which cannot be replicated in vitro. This ensures accurate assessment of antimicrobial performance under real-world usage conditions.
Log reduction quantifies the decrease in microbial population on a logarithmic scale. Higher log reductions indicate greater antimicrobial effectiveness, directly reflecting the product’s ability to control microbial contamination.
Yes, ASTM E1115-11 enables direct comparison of antimicrobial efficacy between different surgical scrub formulations under standardized conditions.
Persistent activity ensures continued antimicrobial protection during long surgical procedures, reducing the likelihood of microbial contamination over time.
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