Work Item
ASTM WK64938

New Practice for Calculating Safe and Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical Equipment and Medical Devices

1. Scope

Pharmaceuticals, Biopharmaceuticals, Nutraceuticals, Cosmetics and Medical Devices


Cleaning, Cleaning Validation, Acceptance Limit, Maximum Safe Carryover, MSC, Total Organic Carbon, TOC, Visual Residue Limit, VRL Visual Inspection, Process Capability, Statistical Process Control, SPC


This standard will be used to provide guidance on implementing the E3106-18 Standard Guide Science-Based and Risk-Based Cleaning Process Development and Validation and for the E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs)

The title and scope are in draft form and are under development within this ASTM Committee.


Developed by Subcommittee: E55.13

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 08-24-2018

Technical Contact: Andrew Walsh

Item: 001

Ballot: E55.03 (23-01)

Status: Will Reballot Item