Supporting Merck toward a new age of aseptic fill-finish processing of highly potent drugs.
Building relationships with customers who are as focused you are on innovation for a better world is a perfect starting point and premise for a successful project. Merck & Co. Inc., a global health care company working to deliver innovative health solutions for today and the future, chose IMA Life to solve an urgent need at their facilities in Rahway, New Jersey.
We spoke to a Global Engineering Services representative at Merck and Stefano Specchia, IMA Life Product Manager, to explore the details of the project and gain insight into the mutual benefits.
The requirement
According to the customer, the primary objective was to source a flexible, multi-format RTU (Ready-to-Use) line that could handle highly potent products up to OEB5, while also accommodating live virus formulations.
This required a robust and adaptable system that could manage a range of products, from serum-based to freeze-dried formulations, without compromising safety or process integrity. The equipment needed to ensure compliance with stringent containment requirements, given the risk level of the substances.
The challenge
Given the equipment's role as a replacement in an urgent situation, Merck narrowed its choice to those suppliers that were not only able to provide adequate support to address the specific needs of handling both potent compounds and live virus formulations, but also in a position to adhere to a strict delivery schedule.
The solution
A solution demanding rapid deployment was needed in order to avoid production delays and uphold commitments to stakeholders. Moreover, there were a number of critical requirements that only IMA Life was able to address satisfactorily.
Stefano Specchia underlines the key reasons why Merck opted for the fill-finish line constructed around INJECTA.
“First and foremost, our experience in handling complex, high-potency products and live virus formulations reassured the customer regarding the adaptability of our technologies and our ability to ensure safe processing without sacrificing operational efficiency.”
Furthermore:
- our solution met the technical specifications
- we aligned well with the challenging timeline
- we provided high-level digital training for Merck's operators
In particular, training aimed at enhancing operational efficiency and ensuring consistent management of the line using standard working parameters. Seen as a crucial requirement, IMA Life was successful in fulfilling this need. According to the customer, there were “no doubts about their commitment to support and optimize our processes.”
The benefits
Advanced robotics, which is a core principle in terms of INJECTA and its design concept, facilitated effective cleaning and containment when dealing with potent compounds. This feature is critical for compliance and safety in handling high OEB-level products. The design also supports greater precision, which is essential for minimizing contamination risks and improving overall production reliability.
The line is also easy to use. Recipe programming is intuitive and enhanced monitoring capabilities also contribute to potentially fewer rejects.
The ultimate value
Faced with a tight timeframe, a building that was not designed to accept the line initially, and a challenging path taking us from the first design phase of the processing line right up to commissioning, training and on-site support, IMA demonstrated “the true value of working with a trusted and committed partner in the field.”
At all times throughout the project - from the design phase all the way through to qualification and support – one of the key factors ensuring success had to be the partnership between the companies and especially the people working in each team.
In conclusion
Moving ahead, it is clear that IMA’s commitment will not diminish thereby enabling the equipment to function as an integral part of the production environment across its entire life cycle.
IMA Life has supplied a fully integrated, isolated line that spans the entire process, from RTU container handling through freeze-drying and downstream operations, including external washing and tray loading. This comprehensive approach ensures seamless compatibility and operational efficiency across all stages of production, meeting the highest standards for containment, precision, and reliability.
INJECTA is the first of a new generation of material handling technologies, setting new standards in the industry. The dedication of the IMA team, their depth of knowledge, and the support resources they provide are instrumental in ensuring timely and effective project outcomes. While certain areas of task execution and design may benefit from minor adjustments, this partnership has underscored IMA’s adaptability and readiness to push technological boundaries to meet evolving industry needs.
For more information on INJECTA and our aseptic processing capabilities:
FLEXIBLE READY-TO-USE COMPONENT PROCESSING LINE • Pharma • IMA Group
HIGH-SPEED PRE-FILLED SYRINGE PROCESSING LINE • Pharma • IMA Group
