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 while simultaneously providing real-time connectivity between relevant stakeholders such as warehouses, supply chains, maintenance, production, quality, and other associated departments.
The heart of pharma 4.0 is the data 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?
Digitalization in pharma 4.0 is a broad and innovative term associated with 4th industrial revolution. Digitalization in pharma 4.0 has the following characteristics.
- Real-time data collection associated with different production processes, equipment, and quality
- Using collected data to optimize various processes
- All the relevant stakeholders, such as production, supply chain, quality, and marketing, are fully connected to meet customer satisfaction and process optimization.
What is pharma 4.0 implementation methodology?
Implementing pharma 4.0 in a real pharma production facility requires key technologies called Enablers. Every technology has different functions and roles that work in a combiner manner to enable the pharma 4.0 framework.
Some key technologies or enablers are described below.
Big Data & Analytics
Big data refers to the hardware and software that collect available data from associated production departments and processes. The data is a real-time indication of various operations and conditions throughout the entire pharmaceutical operation cycle, such as production planning, warehousing, logistics, manufacturing operations and maintenance, suppliers, 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 that fulfils different requirements and processes the collected data. Analytics helps to extract the information from the raw data into a format that can be fed to various enablers of pharma 4.0. The information obtained from the analytics is used for improving the process, and customer requirements, reducing costs and responding to any dynamic market conditions
Robots in the pharma 4.0 framework are used to optimize manufacturing operations in the pharmaceutical industry. They can understand big data and analytics from various sources such as warehouses, supply chains, production and maintenance. They can use this data to execute the associated manufacturing operations aligned with the organizational requirements.
Robotic processes are controlled with little or no human involvement. The robots plan, organize, execute and report the manufacturing process, provided they are fed with the correct, original, real-time data.
Simulation is the ability of the pharma 4.0 framework to simulate different pharma processes, such as production planning, drug development, facility design and product operation in a fully computer-enabled environment. It uses big data to replicate actual processes in the virtual world. It allows various input variables to analyze their impact in the different stages of the product life cycle.
Using simulation, pharma 4.0 allows its users to plan and design in advance according to real ground conditions and market requirements. The user can select from various input variables, such as raw material, equipment, and facility design, that best matches the organization’s needs.
The integration connects all the business functions throughout the pharma organization with the same level of resources.
In pharma 4.0, it is the onboarding process of the related enablers at the same level throughout the pharma organization so that each department, entity or process functions according to the pharma 4.0 framework.
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, which becomes useful to other machines and can then be fed to analytics for further analysis and decision-making. This data can also be stored in centralized storage for future analysis, use or decision-making.
Software analytics also use the data collected through IIOT as a part of big data.
Cybersecurity is the protective measure deployed on an organizational level to protect the collected data. It also prevents any security breach to the organization’s virtual network to disrupt the production process, steal valuable process and product data, and change any process parameter.
Cloud is the virtual storage where the entire data set is stored. Different relevant interested parties, such as software, humans, machines, and computing workstations, can access the cloud storage depending on the approvals and privileges granted. Cloud storage also provides standard security features to prevent breaches and data leaks.
Cloud storage facilities can be on–premises or off-premises on third-party locations.in any case, it is accessed through standard internet protocols, depending upon each device’s approvals and permission granted.
Augmented reality in pharma 4.0 is the human-to-computer interface that enables visualization of actual pharma plants, operations and processing through specialized hardware. The visualization can be created away from the operational area, such as in an office environment, seminars or a meeting.
It allows personnel to gain insight into production, process, operating and environmental conditions without physically going into it.
Augmented reality can also be used for training purposes for new employees. It can also be used by maintenance personnel to detect any fault before it happens. It can also be used by production personnel to monitor the production process for better production.