Mapping the Reliability Journey

March 28, 2023 || Richard Tree Leave your thoughts
 
Project Overview A global medical device manufacturer sought to improve Safety, Equipment Reliability, Overall Equipment Effectiveness (OEE), and cGMP regulatory compliance by performing a plant-wide reliability and best-practice benchmarking assessment. The goal: perform a thorough reliability assessment and benchmarking against industry standards, OSHA, and cGMP requirements to establish a reliability…

MES The Cost & The Benefit

March 28, 2023 || Leave your thoughts
 
Considering a Manufacturing Execution System? For the last two decades, Manufacturing Execution System (MES) has been a hot topic at nearly every automation conference and for good reason. MES is a powerful tool that can deliver process efficiencies, yield improvements, cost avoidances, right first time, and much more. For a…

Speed To Market And Beyond

March 28, 2023 || R. Filannino Leave your thoughts
 
EXECUTIVE SUMMARY The competitive market demands rapid introduction of new GMP products. Manufacturing organizations configure their production systems to achieve the necessary agility and flexibility to rapidly develop and manufacture new GMP products at full-scale. But the market also demands reliable and inexpensive sources of existing GMP products. Many manufacturing…

Power of Design Review

March 28, 2023 || Chip Bennett Leave your thoughts
 
Design Review (DR) and Quality Risk Management (QRM) are considered current industry practice and are essential as enabling processes for verification of facilities, systems, and equipment. But what is Design Review? Why is Design Review underutilized in Commissioning, Qualification, and Validation projects? What are the risks of not performing Design…

PUPSIT: Consideration In Implementation

March 28, 2023 || Jeff J. Gaerke P.E. Leave your thoughts
 
Executive Summary There has been significant debate over the years between regulatory agencies and the pharmaceutical industry regarding the advantages and disadvantages related to patient sterility risk with performing Pre-Use Post-Sterilization Integrity Testing (PUPSIT) of sterilizing-grade filters. This white paper will not add to this specific discussion; instead, the purpose…