WK92659 - New Practice for Performing Swab and Rinse Recovery Studies for Cleaning Validation

Work Item

ASTM WK92659

New Practice for Performing Swab and Rinse Recovery Studies for Cleaning Validation

1. Scope

Pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices

Keywords

Recovery, Swab, Rinse

Rationale

No standards exist for performing swab/rinse recovery studies. Swab/rinse recovery studies are currently performed following incomplete, inappropriate or questionable practices. Laboratory analysts and validation practitioners will benefit from this standard.

Details

Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-29-2024

Technical Contact: Andrew Walsh

Item: 000

Ballot:

Status: