….to further ensure traceability and trust in crucial steps along the pharmaceutical supply chain.
• Proof of Concept (PoC) successfully provides primary packaging with a unique ID to access its own trustworthy digital twin
• Users gain immediate access to quality and process data of products at the item level
• Digital authenticity and trust are ensured through patented crypto anchors and digital certificates
Merck, a leading science and technology company, and Gerresheimer AG, Duesseldorf, Germany, a leading provider of healthcare solutions and drug delivery systems for pharma, biotech and cosmetics, jointly developed a digital twin solution to further ensure traceability and trust in crucial steps along the pharmaceutical supply chain. The proof of concept aims to transform the pharma supply chain by creating digital twins for primary packaging. Through a single interconnected network, participants will benefit from full traceability and digital trust, resulting in cost savings, improved quality and even new business models, thanks to process automation.
“We are convinced that our primary packaging will become the key to enable supply networks across organizations and lead to faster process operations and data-informed decision making,” said Daniel Diezi, Vice President, Digitalization & New Business Models at Gerresheimer.
“At Merck, we develop innovative digital solutions to help companies exploit the exciting advantages of the Industrial Internet of Things (IIoT) and create digital twins they can really trust. We are proud to be a digital sparring partner to help Gerresheimer realize this by putting our patented digital technologies at their service,” said Thomas Endress, Executive Director of EMD Digital at Merck.
With the jointly developed solution, Gerresheimer’s physical primary packaging is provided with a trusted “key”, enabling access to its digital twin. Primary packaging, such as syringes or vials, “travel” through the whole supply chain, from production to the point of care, connecting and collecting information that will be linked to their unique ID. They become the key to unlocking data coming from numerous digital ecosystems, enabling more efficient collaboration among various organizations in the supply network.
The new solution implemented on Gerresheimer products uses blockchain-based platform and multi-patented authentication technologies developed by Merck to anchor physical objects securely in the digital world. In combination with Industry 4.0 standards, this makes it highly trustworthy and reliable. As a science and technology company that operates across different business sectors, Merck also develops forward-looking digital solutions for customers that can be applied in a wide variety of industries.
The joint PoC of Merck and Gerresheimer comprises physical syringes with a secure unique ID, a smartphone application, and access to the digital platform of Merck in order to unlock the digital twin features. The smartphone app is accessible to authorized stakeholders such as brand owners (marketing authorization holders) and quality assurance officers of the manufacturer. After authenticating the syringe and reading the unique ID, the authorized user can access features such as quality data on demand, root-cause analysis data, and customer complaint handling:
• Quality data on demand: retrieving the machine-readable certificate of analysis as well as cosmetic and dimensional inspection data
• Customer complaint handling: streamlined complaint handling from brand owner to manufacturer and dashboard-like overview
• Root cause analysis: product-related data such as specifications and aggregation across different packaging levels in combination with quality-related data make it possible to examine errors and spot potential sources for mistakes at the container level.
In this particular case, as in pharmaceutical supply chains where many specialists contribute to overall success, Gerresheimer and Merck intend to onboard further parties to build additional seamless multiparty solutions and exploit the full potential of traceability from production to the point of care. As soon as additional parties, such as contract manufacturing organizations, logistics providers and regulatory bodies, adopt the solution, the potential for automated business logic grows for use cases such as automated machine-to-machine generation of certificates and its exchange across different parties.
Gangolf Schrimpf- photo Merck