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Table of Contents

• Pharma Markets and the Push to Digitize
• How IIoT is Improving Pharma Manufacturing
• How MQTT Addresses Connectivity Challenges in Pharma Manufacturing
• HiveMQ: An Enterprise MQTT Platform for Optimizing Supply Chain and Enabling Regulatory Compliance
• Sparkplug Adds Additional Data Context to Pharma Manufacturing
• Pharma Manufacturing IIoT Use Case Reference Architectures
• • Use Case 1: Pharma Supply Chain Optimization
  • Use Case 2: Regulatory Reporting Enablement
• Conclusion

Pharma Markets and the Push to Digitize

The global Pharmaceutical Manufacturing market is expected to grow at a CAGR of almost 13% by 2030 to $1,190 billion according to Precedence Research. However, despite strong projected revenue performance, industry profits during the same period are expected to decrease due to mounting competition from lower-cost generic drugs, biosimilars and expiring patents of several blockbuster drugs according to IBisWorld.

All of these factors, combined with COVID-19, has increased competition and accelerated digital transformation in Pharma Manufacturing. Pharma 4.0, which is the extension of Industry 4.0 principles to the life sciences manufacturing process, is spearheading these efforts. While Pharma 4.0 mirrors Industry 4.0, there are unique challenges that life sciences organizations face due to industry specific regulations that impact the rate of adoption. Pharma 4.0 is predicated on the Industrial Internet of Things (IIoT), where deep data is harnessed from a myriad of connected sensors and devices and used to make instant and automated operational decisions, and to enable business intelligence at a strategic level. Apart from the usual benefits of IIoT in manufacturing such as increased safety, improved productivity, heightened efficiency, and enhanced sustainability, Pharma Manufacturing also benefits from improved supply chain and automated regulatory reporting. Although Pharma Manufacturing has begun to warm up to IIoT and its possibilities, GEP says that only 30% of the top 20 pharma companies have adopted IIoT technologies in their manufacturing process at some level. This leaves a lot of potential value to be gained in Pharma Manufacturing by properly deploying IIoT solutions to improve everyday operations.

How IIoT is Improving Pharma Manufacturing

The pharma industry, including manufacturing, is experiencing a period of heightened regulatory scrutiny both in the US and globally. This scrutiny is occurring in a number of areas, including quality control activities around manufacturing operations.

IIoT technology is making it possible to automate Pharma Manufacturing operations, optimize supply chains and enable digitized regulatory reporting. With the help of smart sensors and advanced gateways, companies can easily monitor the performance of a system in real-time, automatically adjust parameters for optimum industrial efficiency, and ensure better productivity at all stages.

Some of the ways IIoT is benefitting Pharma Manufacturing include:

1. Getting access to real-time data and achieving visibility of operations throughout the manufacturing process—from supply chain to production to distribution.
2. Eliminating the need for separate testing and sampling steps in the manufacturing process by interlinking processes to ensure data integrity.
3. Allowing for modular automation in a manufacturing plant, helping to easily scale pharmaceutical production as per market demands. Identifying bottlenecks among several processes within a plant, while also indicating whether any equipment is being overused or underused, thereby increasing operational efficiency.
4. Maintaining electronic batch manufacturing records for pharma companies without compromising data integrity which can then be easily used for regulatory reporting.
5. Enabling faster, continuous, and feasible data collection from several processes in a manufacturing plant required for regulatory continued process verification.

How MQTT Addresses Connectivity Challenges in Pharma Manufacturing

The first step towards successfully implementing IIoT in Pharma Manufacturing is to establish the connections to manufacturing machines, processes, databases, and supply chains in order to make the data available to the enterprise data center in a secure, scalable, and reliable manner. However, data connectivity and availability is a big challenge for the following reasons:

1. Disparate systems that don’t necessarily talk to each other seamlessly due to proprietary communication protocols
2. Legacy infrastructure which hasn’t been updated in a long time
3. Manual processes that only experienced technicians understand pose bottleneck challenges, especially for regulatory reporting

Pharma Manufacturing companies need a solution that can consistently overcome these challenges. MQTT is a lightweight publish/subscribe protocol that was specifically created to overcome connectivity challenges by:

1. Establishing MQTT clients that can talk to proprietary systems and then consolidate data to a centralized MQTT broker
2. Connecting to existing infrastructure, creating a standard data layer, and pushing data to make it available to any cloud or enterprise system

Here are some of the advantages of using MQTT in Pharma Manufacturing:

1. With MQTT, all messages are published to a central MQTT broker and all MQTT clients connect to the broker, subscribe to specific topics and receive updates. This broker serves as the ‘single source of truth’.
2. The decoupling of data through the broker that MQTT offers provides a significant advantage when it comes to creating and managing new assets.
3. The publish/subscribe technology on which MQTT is based works much better than the poll/response that OPC UA or other protocols use, especially when it comes to reducing network latency and cellular costs.
4. The smaller and efficient message sizes of MQTT packets helps to reduce network bandwidth usage and costs.

HiveMQ: An Enterprise MQTT Platform for Optimizing Supply Chain and Enabling Regulatory Compliance

HiveMQ is an MQTT-based messaging platform designed for fast, efficient, and reliable movement of data to and from manufacturing machines, processes, applications, and supply chain components to enterprise data locations on premises or in the cloud. Adopting the HiveMQ broker enables customers to optimize the supply chain and create electronic batch reports for optimizing manufacturing processes and regulatory reporting. HiveMQ provides the following features to power bidirectional data movement in Pharma Manufacturing, thus enabling Industry 4.0/Pharma 4.0 and IIoT:

Reliability: HiveMQ supports MQTT’s three quality of service (QoS) levels to control whether a message is sent at most once, at least once, or exactly once. This makes it possible to establish reliability rules for specific messages.

Security: HiveMQ ensures secure transfer of IIoT asset data with industry standards such as TLS, secure WebSockets, and state-of-the-art cipher suites. Support for authentication and authorization includes X.509 certs, username/password, IP-based authentication, and an API that allows for custom authentication, authorization, and permission logic such as OAuth 2.0 integration.

The HiveMQ Enterprise Security Extension (ESE) makes it easy to integrate third-party enterprise security systems into HiveMQ, including support for authentication and authorization using SQL databases, OAuth 2.0 and LDAP. ESE also supports:

1. Pre-processing of authentication and authorization data from MQTT clients and x509 client certificates
2. A structured access log for tracking security-related device information
3. Fine-grained authorization rules to specify permissions for specific clients or a group of clients
4. Access control for the HiveMQ Control Center

Scalability: HiveMQ scales with underlying hardware. The non-blocking, multi-threaded approach allows more than 10,000,000 concurrent device connections while maintaining extremely fast throughput and adding minimal latency. This is especially useful to ensure data is transferred quickly when legacy equipment has inefficient data bandwidths.

High-Availability Clustering: HiveMQ is architected with a truly distributed and masterless cluster architecture, which means there is no single point of failure and the cluster can grow and shrink at runtime without losing data or availability. Support for Kubernetes, OpenShift, and cloud platforms like Azure, AWS and Google, makes it possible to automatically scale HiveMQ to meet the requirements of most Pharma Manufacturing IIoT use cases.

Extension Framework: HiveMQ has an open API and flexible extension framework that makes it possible to integrate Pharma Manufacturing IIoT machine, process, application and supply chain data into existing enterprise systems. The extension framework allows developers to quickly create extensions for custom data processing, device authentication, and device authorization mechanisms. HiveMQ also provides a marketplace of pre-built extensions for Kafka, MongoDB, and other systems. The HiveMQ Enterprise Extension for Kafka is of particular interest for streaming analytics of pharma data. Apache Kafka is a popular open-source streaming platform that is widely used to share data between back-end systems and applications. The HiveMQ extension solves the difficulty of using Kafka for IIoT by seamlessly integrating MQTT messages into the Kafka messaging flow.

Full support of MQTT 5: HiveMQ provides full support for MQTT 5, the most recent version of the MQTT protocol. MQTT 5 includes new features that make it easier to develop reliable systems and integrate the MQTT data into other systems and is the preferred choice for Pharma Manufacturing applications. HiveMQ is 100% compliant with all versions of the MQTT specification. MQTT 3 and MQTT 5 clients can communicate with HiveMQ simultaneously and all features such as topic wildcards, persistent sessions with offline queuing, retained messages, and quality of service levels are available at scale.

Sparkplug Adds Additional Data Context to Pharma Manufacturing

MQTT is designed to push data to and from thousands of remote devices across numerous sites to the enterprise. Sparkplug is a new open-source software specification that sits on top to add context to the data, thus extending use cases. Sparkplug provides MQTT clients with a framework to integrate data and provide context to it by defining data models. HiveMQ is fully Sparkplug compliant.

In the Sparkplug architecture, devices, EoN (Edge of Network) nodes, and the SCADA/IIoT hosts connect to a central MQTT broker to publish and subscribe to data. The SCADA/IIoT host is the central application that pharma system operators use to remotely manage and monitor the overall state of the Pharma Manufacturing systems. The advantage here is that unlike a traditional SCADA system the SCADA/IoT host is not responsible for directly establishing or maintaining connections to devices. That is managed by EoN nodes that are used to connect legacy infrastructures. Devices and sensors collect data and pass it on to the upper layers. MQTT applications, or secondary applications, are components that participate in Sparkplug communication and can generate and process MQTT messages.

Pharma Manufacturing IIoT Use Case Reference Architectures

Here are common architectures for supply chain optimization and regulatory reporting use cases seen in Pharma Manufacturing:

Use Case 1: Pharma Supply Chain Optimization

Pharma supply chain managers want to trigger necessary workflows as needed from a centralized location based on leading indicators derived from sourcing, supplier inventory and shipping. Supply chain performance data flows through the HiveMQ Broker to the cloud provider’s infrastructure where it is ingested and then analyzed or monitored.

There are two major advantages to using a HiveMQ Broker in this scenario. The first is that it provides a very scalable solution that load balances the control data from different systems that may be in remote locations, worldwide. Secondly, it offers tools to provide a high level of factory IIoT data observability and transparency to overcome any data bottlenecks going to the cloud or coming back to remote locations.

Use Case 2: Regulatory Reporting Enablement

Regulatory scrutiny and enforcement actions will certainly continue given the ever increasing volume of drug sales by pharma companies. The industry will be challenged to move beyond the current crisis management approach to regulatory compliance and implement a comprehensive strategic approach that builds compliance into the way companies do business.

The batch records, which maintain all the details of the manufacturing steps and are typically manual, will need to be digitized. The manufacturing batch records data, along with other factory data, flows through the HiveMQ Broker to the cloud provider’s infrastructure where dashboards and reports can be created.

In this use case, the HiveMQ Broker is highly scalable and balances the load of the control data and process data being received from various locations. In addition, it provides highly secure communication between HiveMQ and the remote systems or cloud with features like TLS/SSL support, OAuth 2.0, X.509 certificates, etc.

Conclusion

Many Pharma Manufacturing organizations are digitizing their operations and IIoT technologies are at the forefront. This push to digitize and enable IIoT comes with challenges including unreliable networks, legacy infrastructure, costly bandwidth, inefficient protocols, and complex systems. The MQTT protocol addresses all of these challenges and provides a simple and reliable way to connect to various systems and bring data to the enterprise.

The MQTT protocol uses a publish and subscribe architecture that efficiently moves data between various systems and enterprise IT cloud services, while also providing high quality of service data transfer. The HiveMQ Enterprise MQTT broker is the platform best suited to enable Pharma Manufacturing supply chain optimization and regulatory reporting due to its performance scaling capabilities, implementation of all MQTT 5 features, and professional support services. In addition to MQTT, Sparkplug provides additional benefits to Pharma Manufacturing companies by enabling mission-critical, real-time OT operations.

Contact us to discuss how the HiveMQ enterprise MQTT platform can help solve your connectivity needs in a secure and reliable way, enabling your IIoT and digital transformation journey.