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.
Work Item Status
Date Initiated: 10-15-2021
Technical Contact: Richard Hall Hall
Item: 000
Ballot:
Status: