ASTM E2361-13 (2021) PDF

Full title and description

ASTM E2361-13(2021) — Standard Guide for Testing Leave‑On Products Using In‑Situ Methods. This guide provides recommended test methods and sampling procedure options for evaluating the antimicrobial performance of leave‑on products (for example, alcohol hand rubs and lotions containing antimicrobial ingredients) using in‑situ (on‑skin) sampling approaches rather than rinse‑off methods.

Abstract

This guide describes considerations and practical options for sampling and recovery after application of leave‑on antimicrobial products on skin. It covers objectives for selection of recovery techniques (transient vs. resident flora, superficial vs. deep flora), typical sampling methods (contact plating, controlled swabbing, cup‑scrub techniques), and selection of media and recovery approaches appropriate to the intended use of the product. The document is intended to help laboratories and product developers choose in‑situ test methods that reflect realistic product use.

General information

• Status: Active / reapproved (2021).
• Publication date: Reapproved / republished in 2021 (designation E2361‑13(2021); released October 2021). The original adoption was 2013 (E2361‑13).
• Publisher: ASTM International (Committee E35, Subcommittee E35.15).
• ICS / categories: 11.140 (hospital equipment / antimicrobial testing context).
• Edition / version: E2361‑13(2021) — original 2013 edition reapproved in 2021 (document identifier kept as E2361‑13 with 2021 reapproval in parentheses).
• Number of pages: 6 pages (concise guide).

Scope

The scope covers test methods and sampling procedure options for leave‑on antimicrobial products intended for consumer and health‑care personnel use. It focuses on in‑situ (on‑skin) evaluation where organisms are killed or reduced in place rather than being rinsed away, and it notes that sampling approaches for body sites other than hands may require different techniques. The guide does not attempt to specify all safety or regulatory requirements and recommends users determine applicable safety and regulatory practices prior to testing.

Key topics and requirements

• Definitions and objectives for in‑situ testing of leave‑on products (what portion of the skin flora is targeted: transient vs. resident, superficial vs. deep).
• Recommended sampling/recovery methods: contact plating, controlled swabbing with templates, cup‑scrub (detergent/agitation) and other techniques appropriate to the test objective.
• Considerations for selecting recovery media and incubation conditions to capture aerobic/anaerobic or specific organisms of interest.
• Guidance on test design choices based on intended product use (hands vs. other body areas) and interpretation of in‑situ results.
• Notes on limitations and responsibility of the user to establish safety and regulatory applicability before testing.

Typical use and users

Used by product developers and manufacturers of hand rubs, lotions and other leave‑on antimicrobial formulations; microbiology and analytical laboratories performing efficacy testing; infection prevention and control professionals; regulatory reviewers and standards bodies evaluating test methods; and researchers studying skin microbiota and topical antimicrobial performance. The guide helps these users select appropriate in‑situ sampling and recovery methods that reflect realistic product application.

Related standards

Related ASTM documents and test methods in the antimicrobial/hand hygiene area include standards such as E2011 (evaluation of hygienic handwash/handrub formulations), E2946 (methods for handwash formulations using hands of adults), and other E35 committee documents addressing antimicrobial testing and sampling techniques. Earlier versions of this guide (for example E2361‑04R07) are superseded by the current reapproved edition. Users should consult ASTM for the full list of related standards.

Keywords

leave‑on products; in‑situ methods; hand rub; alcohol hand rub; antimicrobial efficacy; recovery techniques; skin sampling; cup‑scrub; contact plating; swab sampling.

FAQ

Q: What is this standard?

A: ASTM E2361‑13(2021) is a concise guide describing in‑situ test and sampling options for evaluating the antimicrobial performance of leave‑on topical products (for example, hand rubs and lotions).

Q: What does it cover?

A: It covers selection of recovery objectives (which portion of skin flora to measure), recommended sampling methods (contact plating, swabbing, cup‑scrub), media considerations, and guidance on selecting methods appropriate to product use (hands vs. other body areas). It does not set regulatory requirements or safety procedures; users must apply those separately.

Q: Who typically uses it?

A: Manufacturers and formulators of leave‑on antimicrobial products, microbiology testing labs, infection prevention professionals, researchers, and regulatory reviewers looking for standardized in‑situ sampling guidance.

Q: Is it current or superseded?

A: The document is shown as reapproved in 2021 (designation E2361‑13(2021)) and listed as active. Users seeking the very latest status or any subsequent revisions or withdrawals should verify directly with ASTM International.

Q: Is it part of a series?

A: It is published under ASTM Committee E35 (Antimicrobials and Alternative Control Agents), Subcommittee E35.15, and appears alongside related antimicrobial testing standards in Book of Standards Volume 11.08. It complements other E35 hand‑hygiene and antimicrobial test methods.

Q: What are the key keywords?

A: leave‑on products; in‑situ testing; hand rub; antimicrobial efficacy; sampling; recovery techniques; cup‑scrub; contact plating.