Work Item
ASTM WK74412

New Guide for Critical Airflow Visualization

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, specifications, and performance standards for the manufacture of pharmaceutical and biopharmaceutical products. The Committee will encourage research in this field and sponsor symposia, workshops, and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

Keywords

Airflow; Smoke study; Aseptic

Rationale

This guides to provide best practices on how to comply with ISO, FDA and EudraLex requirements.

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

Details

Developed by Subcommittee: E55.06

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-16-2020

Technical Contact: Scott Drummond

Item: 001

Ballot: E55.06 (22-01)

Status: Negative Votes Need Resolution

Item: 000

Ballot:

Status: