Operations Excellence: Process Analytical Technology (PAT) to Play Key Role in Advancing Operations Excellence - US and European chapter meetings address PAT adoption levels throughout the biotech ind

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Operations Excellence: Process Analytical Technology (PAT) to Play Key Role in Advancing Operations Excellence
US and European chapter meetings address PAT adoption levels throughout the biotech industry.


BioPharm International
Volume 18, Issue 5

At the European meeting, Christian Woelbeling, a guest speaker from Werum Software & Systems AG, demonstrated compliance and productivity benefits achieved through MES implementation. Woelbeling described the system's core functionalities such as electronic batch records, deviation tracking, events correlation, user guidance, material flow control, equipment logbook management, and production planning and scheduling. With a number of successful biopharma MES implementations already in place and more in the planning or initial design phase, the industry is moving to a new process automation and operations control era, following the direction of other highly advanced industries such as the semiconductor industry.


The objective of Six-Sigma quality is to reduce process output variation so that six standard deviations lie between the process specification upper and lower limits.
The other key session at the European meeting was dedicated to a discussion of the industry's acceptance of Six-Sigma as a key platform for operations excellence (Figure 1). The objective of Six-Sigma quality is to reduce process output variance so that +/- six standard deviations lie between the process specification upper and lower limits.

At the meeting, Tefen discussed its industry experience, highlighting the fact that almost all biopharma manufacturing companies are engaged in some type of formal operations/process excellence effort, which is most commonly structured around the Six-Sigma approach. The industry preference for Six-Sigma could be explained by the statistical theory behind the program methodology, and the biopharmaceutical industry is by nature a science-based, methodical arena. Also, its preference could be attributed to the method's demonstrated success during recent years by leading companies such as GE, Motorola, etc. Tefen also indicated that a typical program structure consists of dedicated "core team" resources ("black belts") plus part-time operations staff involved in improvement projects parallel to their on-going duties. On average ,three percent of the total full-time operations staff is engaged in operations excellence activities.

The consortium members brainstormed on different applications for the Six-Sigma methodology, and although most people agreed that the approach could be applied to almost any business process or system practiced by biopharma companies including administrative activities, they currently are using the methodology primarily for production and quality related projects. The discussion ended with an understanding that the most common benefits of using Six-Sigma include:
  • Reduced rate of de-viations and out of specs (OOS)
  • Increased unit oper-ations yield and overall productivity
  • Reduced lot release time
  • Improved equipment reliability
  • Reduced changeover times between campaigns
  • Documentation and workflow simplification
  • Improved change control business process
  • Reduced time/cost of supplier qualification
  • Improved tech transfer practices
  • Reduced cost and improved productivity of R&D processes

FUTURE ACTIVITY The three local chapters of the BioPharma Consortium conducted their first meetings of 2005. Abbott Bioresearch Center hosted the east coast meeting; Cell Genesys, the west coast forum; and Wyeth BioPharma Grange Castle Ireland, the European meeting. All meetings will be covered in the next Operations Excellence column. For additional information, please visit the consortium section on Tefen's website ( http://www.tefen.com/) or send an e-mail to
.

ACKNOWLEDGMENT The author wishes to thank Marc Puich, director at Tefen, for his contribution to this column.

Amir London is a partner at Tefen Ltd., 1065 East Hillsdale Boulevard, Suite 112, Foster City, CA 94404-1615, 650.357.1120, ext. 115, fax 650.372.1120
.


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