1. Improving Preventive Maintenance of Packaging Process Equipment in a Pharmaceutical Industry Final Presentation By: Anabel Rodriguez

2. Introduction The intention of this project is to: - Apply the concepts of preventive maintenance (PM) - Determine how improvements in PM activities of packaging process equipment affects the overall performance of Mc Neil Healthcare located in Las Piedras, Puerto Rico. Focuses in determine the advantages and disadvantages PM offer to a pharmaceutical industry and how it can be develop to optimize production activities.

3. Introduction - The objective of this project is to reduce the overall rate of occurrence of packaging equipment failures. - The reduction will result in cost savings for McNeil Healthcare in Las Piedras, Puerto Rico.

4. Background Preventive maintenance can be defined as an activity performed on a certain schedule which is intended to prevent breakdowns or deterioration. No equipment should reach the breaking point. There are advantages and disadvantages preventive maintenance offer to pharmaceutical manufacturing industries.

5. Background Table 1: Advantages and Disadvantages of PM Activities AdvantagesDisadvantages Safety – PM increases the margin of safety by keeping equipment in top running condition. Breakdowns generally occur at undetermined times. Lower cost – maintenance costs will decrease as the costs for production losses decreases Reduction of output. Reduction in failure and breakdowns. Faster plant deterioration. Extension of equipment life.Direct loss of profit. Increase equipment reliability.Labor intensive. Increase plant productivity.More spoilt material. Reduced cycle time.Unneeded maintenance of some component. AdvantagesDisadvantages Safety – PM increases the margin of safety by keeping equipment in top running condition. Breakdowns generally occur at undetermined times. Lower cost – maintenance costs will decrease as the costs for production losses decreases Reduction of output. Reduction in failure and breakdowns.Faster plant deterioration. Extension of equipment life.Direct loss of profit. Increase equipment reliability.Labor intensive. Increase plant productivity.More spoilt material. Reduced cycle time.Unneeded maintenance of some component.

6. Background -It is crucial to implement preventive risk based systems in order to meet the essential requirement of assuring the product quality at every moment. Regulatory requirements Reduce available equipment requirements Ensure product availability -The main purpose of a PM program is to reduce production and sustenance costs AdvantagesDisadvantages Safety – PM increases the margin of safety by keeping equipment in top running condition. Breakdowns generally occur at undetermined times. Lower cost – maintenance costs will decrease as the costs for production losses decreases Reduction of output. Reduction in failure and breakdowns. Faster plant deterioration. Extension of equipment life.Direct loss of profit. Increase equipment reliability.Labor intensive. Increase plant productivity.More spoilt material. Reduced cycle time.Unneeded maintenance of some component.

7. Methodology Data was collected from McNeil Healthcare to determine the frequency of preventive maintenance activities at packaging lines. - The equipment downtime hours were compared in terms of unscheduled repairs and required preventive activities AdvantagesDisadvantages Safety – PM increases the margin of safety by keeping equipment in top running condition. Breakdowns generally occur at undetermined times. Lower cost – maintenance costs will decrease as the costs for production losses decreases Reduction of output. Reduction in failure and breakdowns. Faster plant deterioration. Extension of equipment life.Direct loss of profit. Increase equipment reliability.Labor intensive. Increase plant productivity.More spoilt material. Reduced cycle time.Unneeded maintenance of some component.

8. Methodology AdvantagesDisadvantages Safety – PM increases the margin of safety by keeping equipment in top running condition. Breakdowns generally occur at undetermined times. Lower cost – maintenance costs will decrease as the costs for production losses decreases Reduction of output. Reduction in failure and breakdowns. Faster plant deterioration. Extension of equipment life.Direct loss of profit. Increase equipment reliability.Labor intensive. Increase plant productivity.More spoilt material. Reduced cycle time.Unneeded maintenance of some component. Figure 1 Unscheduled Repairs Downtime Hours versus PM Downtime Hours in Packaging Equipment at McNeil Healthcare

9. Results Figure 2 summarizes: Implementations made to Preventive Maintenance activities. Changes to Mc Neil Healthcare procedures. Proposed implementations estimate a 10% reduction in overall equipment failure. Figure 2: Unscheduled Repairs Downtime Hours versus PM Downtime Hours in Packaging Equipment at McNeil Healthcare

10. Conclusions The objective of this project was met. The overall rate of packaging equipment failure was reduced. Reductions on equipment failure can also bring cost savings to Mc Neil Healthcare without jeopardizing regulation requirements.

11. Conclusions - The most important benefit of improvements in preventive maintenance program is that the organization will pay less now to do planned work versus very expensive unscheduled repairs. - Avoid troublesome conditions causing production to stop and loss of revenue. - Good PM saves money over a product’s life cycle

12. Thank You Questions?