Pharma 4.0 is the latest trend in the pharmaceutical industry that represents the methodology of digitalization. This article discusses what is pharma 4.0 and what are the technologies behind it.
Pharma 4.0 utilizes the latest digital and automation technologies to modernize traditional pharmaceutical manufacturing operations. It provides real-time connectivity between different segments such as warehouses, supply chains, maintenance, production, and quality for efficient production processes, enhanced quality in the product, and cost-effective operations.
The heart of pharma 4.0 is the techniques and software analytics to collect and analyze real-time data. It then communicates this real-time data throughout the entire pharma setup to optimize production, fulfill customer requirements, and respond to changing market dynamics.
What is pharma 4.0 ?
Digitalization or pharma 4.0 is an innovative term that has been derived from the concept of the fourth industrial revolution or industry 4.0. In it data and digital technologies form the basis of pharma processes.
Pharma 4.0 includes
- Real-time data collection from different production processes, equipment, and quality
- Using collected data to optimize processes by processing through analytics
- Connectivity among relevant stakeholders for process optimization and customer satisfaction
What is pharma 4.0 implementation methodology?
Implementing pharma 4.0 in a pharma production facility requires key technologies called Enablers. Each technology has its specific function in pharma 4.0.
Some key technologies or enablers are described below.
Big Data & Analytics
Big data refers to the large collection of datasets spread across the entire pharma process, equipment facility, and alike to collect raw data. The data is a real-time indication of the entire pharmaceutical manufacturing cycle, such as planning, warehousing, logistics, manufacturing operations, maintenance, supply chain, marketing, and customers. The data is then converted into a format understandable by machines and computers for further processing by analytics techniques.
Analytics is generally defined as a set of algorithms to process the collected data. It helps to extract useful information from the big data that can fed to various enablers of pharma 4.0. The output from the analytics is used for improving the process, fulfilling customer requirements, reducing costs, and responding to any dynamic market conditions
Robots
Robots in pharma 4.0 are used to optimize manufacturing operations in the pharmaceutical industry. They are able to process information from analytics, fed through sources such as warehouses, supply chains, production and maintenance. They can use this data to plan, execute, and manage manufacturing operations in line with the organization’s requirements, provided they are fed with the correct, original, real-time data.
Simulation
Simulation is the ability to simulate pharma processes, such as production, drug development, facility design, and manufacturing operations, in a virtual environment. It uses big data to replicate actual processes. Various input variables can be used to analyze their impact on the different stages of the product life cycle.
Simulation allows to plan and design pharma processes in advance, using actual scenarios. The user can select various variables to optimize the process, such as raw material, equipment, and facility design, according to the organization and market needs.
Integration of new technologies
It is the integration of entire digital technology into each business function in a way that each function equally gets its share of resources. It can be enabled by investing in systems and processes for each pharma business function to enhance efficiency and productivity.
In pharma 4.0, it is the onboarding process of enablers to all departments, processes, and functions at the same level. The type of integration can include data Integration, system integration, and technology integration.
Industrial Internet of Things – IIOT
Industrial Internet of Things – IIOT is the industrial version of the Internet of Things. It allows industrial machines to act smartly and communicate with other compatible machines. Commutation enables the sharing of valuable information for data-driven decision-making, real-time monitoring, and process automation.
IIOT is the combination of internet and physical monitoring devices & sensors. It enables these devices to collect relevant data and communicate with enabled devices through the internet. The data can then be analyzed by various functions for different acceptance criteria in the analytics.
For example, IIOT-enabled sensors can measure temperature & humidity and transmit it to a centralized repository through the internet, usually Cloud storage. This temperature & humidity data can be analyzed by analytics for different process-related applications, such as production and improvement.
Cybersecurity
Cybersecurity is a combination of various measures to protect the organization’s digital assets and collected data.
Since the foundations of pharma 4.0 are built upon digital technologies and data, that keeps pharma processes connected to both inside and outside world. This connectivity makes them vulnerable to digital & cyber attacks.
Cyber attacks in pharma 4.0 enabled environment can disrupt manufacturing operations, data breaches, and leak sensitive corporate data into the hands of competitors.
Cyber security in pharma 4.0 is a structured approach to protect digital footprint. It includes security training among the employees, assessing loopholes in the digital assets of the organization, and defensive measures to protect against attacks. It enables pharma organizations to establish dedicated resources and expertise to defend against cyber attacks.
Cloud
Cloud is the virtual storage where the entire data is stored. It can be accessed by all the components, such as software, humans, machines, and computing workstations of pharma 4.0, provided they are allowed to do so. These components have defined approvals and privileges, depending upon their role in pharma organization life cycle
Cloud storage also provides standard security features to prevent breaches and data leaks.
Cloud storage can be on-premises or off-premises. In any case, it is accessed through standard internet protocol.
Augmented Reality
Augmented reality in pharma 4.0 is the human-to-computer interface that enables visualization of actual pharma plants, operations, and processing. It requires specialized hardware to view the virtual version of the physical process or plant.
Through Augmented Reality, a user can create visualization away from the operational area, and can be viewed in an office environment, seminars, or a meeting without physically going into it.
Augmented reality can be used for training new employees. It can be used by maintenance personnel to study and detect any fault before it happens. It can also be used by production personnel to monitor the production process for optimization.