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
This guide extends the life-cycle approach to CIP cleaning process development and validation to the earlier stage of equipment design & development.
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; OEE; overall equipment effectiveness; sustainability; water usage
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: 001
Ballot: E55.11 (23-01)
Status: Negative Votes Need Resolution