CASE STUDYUNITEDWITH
COLLABORATION& CARE

Flexibility enables managing large leaflet on automatic
packaging line
A large multinational pharmaceutical company
asked the Thermo Fisher Scientific Ferentinosite to fix an issue that resulted from a change
request to increase the size of the productinformation leaflets. These leaflets were
important and required for regulatory andmarketing reasons.
Problem to solve
Due to regulatory and marketing reasons, Thermo Fisher’s client
voiced a need for larger product information leaflets. Initially, dueto the new, larger size, there were several problems with managing
the leaflet format (300 x 600 mm) which caused downtime of
the machine, breakage of rollers, and leaflets not being foldedwell. Because of these issues, the product was temporarily
packaged on a slower, semiautomatic line used for some of thesmaller volume stock keeping units (SKU). Several SKUs (about220 SKUs) were impacted by the leaflet size change. Due to thehigh batch size volumes being packaged, the Client asked for an
urgent solution to improve the packaging of these SKUs with afully automated solution to better ensure meeting timelines.
As further background, the supplier sent to the Ferentino site
unfolded leaflet formats which were either folded automaticallyon the automatic line or manually for the semi-automatic line,
causing further delays. A solution was urgently needed.

Solution
Due to the criticality of the situation, a team was created tocomplete an urgent internal and external assessment on how tosolve the problem. A multi-functional project team was createdwith representatives from the following departments: Packaging
Development, Engineering, Documentation, Production andEngineering & Equipment Validation. The team meticulously
discuss various scenarios to decide which solution would bebest. They outlined and discussed several considerations andthen met and discussed with the client to ensure client buy-in
before agreeing on the solution to implement pre-folded leafletsfor both lines.
Based on the chosen solution of implementing pre-folded
leaflets for both lines, a feasibility study was carried out withleaflet suppliers to avoid any impact on artworks changes. The
study was conducted on all leaflet formats managed by both thepackaging lines including a total of about 1000 SKUs. In particular,suppliers were requested to check the feasibility for providing thepre-folded leaflets while maintaining the unchanged position oflaetus code for automatic feeding.

Mechanical adjustments were necessary for the automated line
to implement the automation of the packaging process and toeliminate the stand alone equipment used to fold the leaflets forthe semiautomatic line.
During implementation, various activities were carried out ina very short time including conducting machinability trials(including Factory Acceptance Testing (FAT), Site Acceptance
Test (SAT), Installation Qualification/Operation Qualification(IQ/OQ), updating about leaflet technical specifications to include
the fold setup, and updating packaging line working instructions
for all the impacted SKUs for both lines.

Customer satisfaction
The client was very satisfied with the diligence of the project
management team and the team’s ability to meet the timeline ofimplementation. The client highly appreciated the feasibility study
carried out with supplier and the solution found regarding theleaflet folding that allowed no changes to the artworks, with noimpact on marketing / regulatory side.

The team met the project timeline and in six months all activities(including the feasibility study with suppliers) were completed,and the first batch was successfully packaged on the automaticline with the larger leaflet.

Solution advantages and cost saving
In spite of the increased leaflets costs due to additional folding
step performed by the supplier, the implementation of pre-folded
leaflets on the packaging lines enabled a reduction in time andcosts for each batch due to the following:• The overall packaging timing was reduced since a
process step (leaflet folding) was no longer executed;• Material yields were increased 2% by the eliminationof the separate processing step
• Equipment wear part costs were reduced by thesimplification of the automated folding process• Elimination of a maintenance contract for the off-line
folding equipment
Other benefits related to the implementation project were:• Additional free capacity on both the semiautomaticand automatic line
• Increased Overall Equipment Effectiveness on theautomatic line

+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
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