Case story with AJ Vaccines
”LSS understands our business and found the best solution in a short period of time”
AJ Vaccines needed to find a solution, in order to make their packaging compliant before EU serialization requirements came into force. LSS customized a standard solution that got AJ Vaccines across the finishing line in time.
Short about the solution
- For AJ Vaccine's packaging line, LSS has developed a module that provides tamper evident sealing to prevent falsified medicines from entering legal supply chains to fulfil the EU FMD directive. In addition, LSS has for the Tamper evident solution made testplans and developed IoT software to work up against Tracelink, that identifies every single carton so the product can be traced all the way from the manufacturer to end user.
There is a lot to consider when you are a company in the pharmaceutical industry with its numerous patient safety regulations. These challenges were also faced by AJ Vaccines, the company that took over the production facilities in the heart of Copenhagen from Statens Serum Institut and became a private company in 2017.
Shortly after its launch, AJ Vaccines was facing the new EU FMD regulations concerning the serialization of products. They had no choice but to act quickly before the requirements came into force on February 9, 2019. Charlotte Joost, project manager at AJ Vaccines, headed the project and gathered the expert knowledge of AJ Vaccines employees from different departments. As the timeline was short, there were no time for mistakes, and all input needed to be considered:
– At AJ Vaccines we needed to find a solution suitable for integration into our existing production. It was also important to find a supplier that was able to deliver up and running solutions before the deadline, or else we were not able to sell our products in the European market, she says.
Customized standard solution
AJ Vaccines wasted no time getting in touch with LSS; a company they already knew from earlier labelling projects. In order to meet the requirements for the EU FMD regulation, LSS had developed a standard solution for ATD (Anti Tampering Device). The Tamper evident labeller was developed to be very flexible and handle different sizes of cartons, and easily adaptable for different production lines.
– From the beginning, LSS worked very professionally. They knew the demand of the EU FMD and understood our business. LSS devised a practical customized version of their standard tamper evident labelling solution to fit our production facilities. The LSS team had a solid understanding of our situation and the urgent needs we were facing.
The solution resulted in a module that could be connected to the existing packaging line as an extra in-line operation. The labelling module ensures tamper proof sealing of the cartons. LSS developed software that allows every single carton to be identified and data registered with Tracelink until it reaches the end user –and LSS also prepared test plans for the machines. The module was developed to be adapted to the other machines in AJ Vaccines' packaging processes.
– Also, the operators at AJ Vaccines are very pleased with the interface of the solution. They explain it as very intuitive and easy to operate via the touch panel.
Successful relationship
It was not only LSS who worked under high pressure. All departments at AJ Vaccines were involved in the serialization project.
– Although it was extremely ambitious, we finished the job in time because we managed to bring together people with the right skills from the very beginning, both internally as well as externally. When we had to speed up the process, we qualified and tested the module in close cooperation, says Charlotte Joost, adding that opting for LSS as a supplier benefited AJ Vaccines in more ways than one:
– LSS has demonstrated that their professional knowledge is exceptional. We had a close relationship throughout the entire process – not only with our contact person Jens Heidemann, but also with other key employees. Being able to get in touch with the right people from day one made everything much easier.
Throughout the entire journey, the team adjusted and optimized the processes and teamwork, explains Charlotte Joost, and emphasizes:
– LSS understands our business and found the best solution in a short period of time. The team entered an ambitious project knowing about the tight deadline. And because we were in this together as partners, we were able to solve challenges immediately as they came up while still being able to make the solution in time. This is what happens when deadlines and teamwork are taken seriously.
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