Work Item
ASTM WK78595

New Guide for the Design of Clean in Place-Friendly Equipment for Pharmaceutical and Biopharmaceutical Applications (CbD Clean by Design).

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

clean in place; clean-in-place; CIP; clean by design; CbD; necessary non-value-added process; NNVA process; SMED; single minute exchange of dies; kaizen; 5S; 6S; cleaning process optimization; design for cleanability; increase capacity; reduce down-time; increase productivity; reduce energy usage; reduce water usage; reduce chemical usage; carbon footprint; green

Rationale

Need: Pharmaceutical and Biopharmaceutical facilities currently lose productivity and waste resources because equipment has not been optimized for easy, rapid and robust CIP cleaning. The result is long and stressful cleaning validations which hinder future optimizations - often with the easy excuse of regulatory pressure. Use: By pharmaceutical & biopharmaceutical manufacturers as a guide to specify cleanability and OPEX requirements on URS documentation for new equipment and facilities. By equipment manufacturers and regulators as a guide to good practice. Users: Pharmaceutical & biopharmaceutical manufacturers. Project Engineering companies. Equipment manufacturers. Regulatory bodies.

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

Details

Developed by Subcommittee: E55.03

Committee: E55

Staff Manager: Travis Murdock

Work Item Status

Date Initiated: 10-15-2021

Technical Contact: Richard Hall Hall

Item: 000

Ballot:

Status: