Standard Processes, Different Results: A Global Controlled Environment Evaluation Across 42 Labs

History

After several In-Person interviews competing with multiple 1st tier firms One Source Environmental was selected to collect “operational” controlled Environmental Performance data at approximately 42 separate labs worldwide. Locations included many across the continental United States, along with labs in Malaysia, Hong Kong, France, and the United Kingdom.

Scope

All lab installations produced product using the same recipes, same process equipment and same environmental criteria and Standard Operating Procedures (SOPs) but were realizing dramatically different results. Product yields varied from 50% to 95% depending on the lab.

Through collection of specific data including but not limited to Airborne Particle Concentrations, Differential Pressure Levels, Temperature & Humidity data logging, Filter Integrity analysis, and Airflow volume & velocity data we were able to chart and characterize operational performance at each lab in a way that was apples-to-apples due to the aforementioned process similarities.

Data was collected based on an agreed upon approach between Client and One Source Environmental so that the most critical and same type of controlled production areas within each lab were evaluated using the same techniques and instrumentation.

Conclusions

After collecting data for almost one year the resultant work product was tabulated, and the results were eye opening for the Client.

The list of irregularities is too long to list in total but included anomalies such as damaged filters, deviations in settings, Geographic considerations as to external environmental factors, variations in belt speeds, temperature controls, airflow volume balance, mechanical equipment maintenance, adherence to recipe control and various housekeeping variances to name a few.

The totality of information acquired has allowed the Client to implement many changes to a variety of Lab process and quality related specifics in many instances resulting in immediate yield improvements. Ongoing improvement efforts and re-verification has confirmed initial findings resulting in more predictable outcomes and has contributed directly to ROI.