Common Challenges in Today’s Pharma Packaging Lines
According to pharmaceutical industry OEE benchmarks, a typical manufacturer has an OEE of approximately 37%, with planned and unscheduled downtime accounting for nearly 50% of losses. An additional 20% of losses are linked to performance concerns, such as micro-stops, and 6% to quality losses (see image below on the left).
On the other hand, analysis reveals that top-tier pharmaceutical manufacturers achieve an OEE of around 70%. These high performers have enhanced and automated their operations using Pharma 4.0 technologies. In such setups, availability typically reaches 75%, while performance and quality losses are nearly negligible (see image on the right).
Apart from this:
● Manual inspection and validation failures due to fatigue or oversight lead to rework and recalls.
● Without integrated data logging, organizations miss out on analytics that can prevent errors and drive continuous improvement.
● GAMP 5 and 21 CFR Part 11 compliance demands extensive documentation.