Operating since 1876, Eli Lilly and Company is one of the largest pharmaceutical companies in the world. Their manufacturing plant in Spain alone has more than 1,200 employees working in a variety of areas including therapeutics, bio-medicines, oncology and animal health and is one of the eight research and development plants owned by Eli Lilly and Company around the globe.
Lilly’s considerable success has been built on its research and development activities, promoting and supporting their corporate vision of making a significant contribution to humanity by improving health in the 21st century.
Pharmaceutical companies are constantly monitored, both internally and externally, to ensure they are in compliance with good manufacturing practices. Manufacturers should have a complete audit trail of all machinery and equipment used, covering everything from tooling usage to maintenance. This is not only good practice, but an important regulatory requirement in the pharmaceutical environment.
Lilly Spain previously used a tool management system to comply with regulations, however, the software used an outdated US-based system which was no longer supported and maintained. Furthermore, key requirements to maintain a full audit trail, such as traceability features for individual punches, were unavailable without costly and time consuming technical support and guidance.
I Holland were approached to offer a solution which would update Lilly’s current monitoring system. I Holland’s Tool Management System (IH-TMS) was introduced which uses innovative software technology.
The standalone tooling management system has been developed to allow proactive monitoring of tool rotations, tooling inventory and tooling maintenance. The system, which is 21 CFR Part 11 compliant, also keeps a record account of tablet quantities by number of tablets, work order or batch information, all of which is completely flexible to the user’s needs.
Monitor Tooling Life
When choosing a new management system, Lilly Spain identified four main goals that the software should achieve. The first being the ability to monitor tooling life commencing from when a tooling set is received from the manufacturer, until the tooling is disposed of and no longer in use. By monitoring this process, the company would be able to accurately predict when tooling would need to be replaced and in turn decrease tablet press downtime; positively impacting on finances.
IH-TMS was chosen for its ability to record and report production problems associated with a specific set of tooling during its life cycle, which then allows the forecast of potential future issues in production. This feature is particularly helpful with problems such as localised wear or sticking issues to the punches and dies that may indicate the need for repair work, cleaning or replacement.
The costs of tool replacement are often known, however there can be unexpected expenses including the replacement of tools due to avoidable damage. Implementing a management system to monitor aspects of the tooling cycle will increase production, reduce tablet press downtime and lead time to market.
The second goal centred on the traceability of individual punches and dies within a set. This included where the tooling is stored, maintenance actions which have been carried out during its lifetime and what machines the tools have been used in.
IH-TMS was able to help with this goal due to its capability to store tooling and tablet drawings with the added benefit of taking pictures of detected tooling problems (such as knocks, corrosion, burrs, etc.) This will allow Lilly Spain to easily send working images to tooling experts, helping their trusted supplier to offer expert advice and find a solution to any manufacturing problems. Additionally, ongoing monitoring ensures that there are constant observations of existing actions guaranteeing longer tooling life. This includes changes to existing maintenance procedures and even predicting when new tooling would need to be ordered, again decreasing tablet press downtime.
The third goal Lilly Spain looked at was the reporting abilities of the different management systems available in the market place. The aim was to properly understand and identify areas of potential improvement in the company’s tablet production system. Specific reporting requirements included audit reports, maintenance action reports and inventory and product reporting.
One of the benefits of IH-TMS is its ability to generate nine different types of reports, to support Lilly’s regulatory compliance goals. The company work towards the FDA’s Code of Federal Regulations – 21-CFR part 11 protocol. This means that once reporting has been issued, the documents cannot be altered, leaving no room for queries by auditors. Reports can also be saved locally to the computer and sent to higher management for review, without time consuming manual entry and the potential for error. Furthermore, the system supports free type commenting on issues in which the production engineer or user deems necessary, providing a full audit trail throughout the entire life of an individual tool.
Ongoing technical support
Lastly, Lilly Spain required a new software supplier that was able to offer the assistance and technical support its previous systems manufacturer could no longer provide. Therefore, a key consideration when buying a new management system was continuing confidence in the supplier and the assurance that guidance would be provided by I Holland staff whilst Lilly learnt to use the software. IH-TMS satisfied this goal with the use of modern 64-bit Windows 10 technology that would be supported for years to come.
As part of the installation service, I Holland visited Lilly Spain’s site during a four-day programme to implement IH-TMS to the company’s specific requirements. The onsite training and implementation enabled I Holland engineers to completely understand the exact needs of the customer, providing assurance to Lilly that IH-TMS was tailored to their objectives. This results in confidence (for both I Holland and the customer) that the system was set up in accordance with onsite standard maintenance procedures, and that users of the system are fully trained to customise the software to their requirements if they should change in the future.
Pablo Poza, Maintenance Coordinator at Lilly Spain, said: “The whole system will be very useful, it is very complete and more intuitive than any other system we have seen. We have been very happy with the installation process and have learnt a lot.”
Liam Preston, Sales and Service Engineer for I Holland, added: “I really enjoyed meeting everyone involved in tablet production at Lilly Spain and helping them to set up the software to fit in with existing operating procedures. I look forward to hearing the benefits they reap from IH-TMS in the future.