Installation and validation of the new Uhlmann packaging line at Organon

In this blog, Ophélie talks about her experience installing a new packaging line at Organon, an innovative pharmaceutical company with more than 100 years of experience in women's health products.

An industrial engineer by training in electromechanics, Ophélie started as a project engineer at Advipro in January 2023. Two weeks later, she started her first project at Organon in Heist-op-den-Berg, where she focused on supporting the installation and validation of this new packaging line.

In order to introduce new products and increase capacity, an old packaging line was taken out of service and replaced with a new line. For this purpose, two new packaging machines were purchased from Uhlmann. Some machines from the old line were recovered.

This project included qualification of the new machines as well as technical follow-up, planning and communication between different parties, such as contractors, suppliers and internal departments. Thanks to months of preparation and a tight time schedule, we were able to start immediately after installation. I executed the project together with Organon's project lead. Because there was no defined division of labor, I had the opportunity to interact with all aspects of the project. For example, I was responsible for writing the validation documents and running the tests on the line. I also managed the planning and contacts with contractors and suppliers, among others, and followed up on the technical side together with the project lead.

The Uhlmann packaging line is divided into a primary and secondary section, separated by a glass wall.

Primary section

The primary section houses the Thermoformer, which makes blisters for tablet packaging. This involves passing bottom film, such as PVC, past a heating station to form cavities at the forming station. This process is visualized in Figure 1. The forming station consists of two forming blocks that form the film (Figure 2). Then the cavities are filled with tablets via a feeder, monitored by a camera, and sealed with a cover film such as aluminum. Variable data such as batch numbers are printed and checked on the cover film. Finally, individual blisters are cut from the film.

Secondary section

The blisters are led via a transport chain through an opening in the glass wall to the secondary section, where they are packed into cartons together with a leaflet by the cartoner. Then the filled cartons undergo a weight check by the checkweigher to verify the presence of the correct components. Next, the Tamper Evident Labeler prints variable data and checks it with a camera before sealing the carton. Then the cartons are bundled by the bundler and placed on a grouping table, where operators pack them into group boxes.

For the Uhlmann packaging line at Organon, a thorough validation procedure was completed to ensure that the production of packaged products meets the highest standards. This procedure included several steps for both the new machines and the reclaimed equipment.

Validation of the Newly Purchased Machines

The following steps were completed for the Thermoformer and Cartoner:

1.         User Requirement Specification (URS):

o A detailed list of requirements was prepared to ensure that the machines met functional and operational needs.

2.         Factory Acceptance Test (FAT):

o Extensive testing was performed at the manufacturer to verify that the machines met all specifications and performance criteria.

3.         Site Acceptance Test (SAT):

o After installation at the site, similar tests were performed to verify that the machines were properly installed and operational according to the URS.

4.         Installation/Operational Qualification (IOQ):

o This phase included detailed testing to ensure that the machines were correctly connected, calibrated and configured according to requirements. This included checking that all documentation and certificates were in order.

This phase included testing/reviewing the following items:

• Was the machine installed as expected?
• Are the correct parts installed on site?
• Are the rating plates as expected?
• Is the related documentation available and approved? Was a calibration performed?
• Is everything connected correctly?
• Are the necessary material certificates available and compliant?
• Can only authorized persons log in? Are the proper accesses linked to each level?
• What software is used and is this backed up?
• Are all alarms working?
• Complete check of the (critical) functionalities

Product-Specific Validation

At that time, the line had been fully validated, but no specific consideration had been given to the products that would be packaged on the line. Since each product required a unique blister design, a specific tooling set was used for each product. Such a set typically includes forming plates, sealing plates, a feeding tray, and more. The following tests were performed for each product:

• Tooling Qualification: testing whether the toolings produce good blisters by checking for complete formation of cavities, minimal film shrinkage when heated, and correct sealing of top film to bottom film without leaks, at various temperatures and speeds.
• Feeder Qualification: Verify that the tablet feeder operated efficiently and accurately at maximum production speed.
• Camera Qualification: Verifying that visual inspection cameras worked correctly to accept only properly filled blisters and reject defective or improperly filled blisters.
• Ranging Study: Capturing optimal operational parameters such as speed, mold temperature and seal temperature for consistently high-quality production.

Finally, Performance Qualification (PQ) tests were conducted to verify that the entire process works from A to Z. PQ testing serves to ensure that a product's entire packaging process meets predetermined quality requirements.

Through preparation and good cooperation between all parties involved enabled the successful completion of this project. The quality and safety of the machines were guaranteed by FAT, SAT and IOQ testing, along with specific qualifications for the tooling, camera and feeder tailored to the line's products. The execution of PQs confirmed the correct operation of the entire packaging process, making the new packaging line fully ready for production. This relieved pressure on other packaging lines and enabled future capacity increases and increased flexibility within the department.

Installing and validating the new Uhlmann line was my first challenging project within Advipro and proved to be a perfect start to my professional career. The pleasant cooperation with my colleagues at Organon has ensured that both I and Organon look back on this collaboration with satisfaction. I look forward to staying involved in future projects within this company.

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