Intense competition, higher production requirements and a strict regulatory environment place pressure on pharma manufacturers to optimise production. Speed to market is more important than ever to reach new emerging markets, to compete with generics and to get the most out of products before their patents expire. Manufacturing processes are not fully automated and manual operations & data recording are prone to errors. Hence, batch rejection incurs huge losses. 45% of manufacturing executives report the inability to access data as a key barrier to solving their challenges.
Addressing industry demands
The COVID-19 pandemic is shaping the industry’s transition to digitalisation in multiple ways. Notably, social distancing measures have prompted substantial changes to how and where work is done. Companies are being forced to be more flexible and consider remote options, including having a qualified person working from home, having workers who are essential for business continuity and unable to be onsite, which brings a business case to digitalisation.
Pharmaceutical manufacturing companies can achieve flexibility, optimised production and regulatory compliance with automation, process control and information solutions. It is important to harness the power of an integrated control and information system to build a connected enterprise and the ability to attain organisation-wide connectivity & visibility.
In the pharmaceutical industry, digitalisation involves developing and implementing digital technologies at all levels of operations. The aim is to transform the industry by capturing, analysing and using vast amounts of data collected from a wide range of sources to support research & development (R&D), clinical development, drug manufacturing, supply chain management, patient engagement, Quality Assurance (QA) and Quality Control (QC), product safety monitoring and other objectives.
The Pharma 4.0™ operating model is interconnected, meaning that the digital tools allow for a fully connected network to allow direct communication between all levels in an organisation. There is a movement towards building digital twins to virtually model how the operation will function even before plant construction begins. Successful facility design thoroughly anticipates needs related to automation levels and optimal data flow across the product lifecycle, including how data from plants, labs, products and supply chains fit together. This focus on increased digital integration should stretch from the physical layer of the plant to how the sensing, controls & automation work, all the way up to enterprise management & the supply chain.
Line integration & connected enterprise
Line integration & connected enterprise automates data collection to help speed up the documentation process and reduce the likelihood of errors. The logged data reduces cycle times by optimising every stage of the product life cycle. There is an increase the inventory turnaround times leading to greater efficiencies in the production, and compliance efforts enable the industry to lower the cost of operations by reducing human errors.
Supervisory remote batch status monitoring allows a single operator to service several processes. These reports are stored in an electronic form to allow batch traceability. The historical data available for trending and process analysis enables us to configure dashboard reports with role-based KPIs to provide operators & management clear, actionable and real-time information.
Increased efficiencies reduce costs and enforce compliance in real-time that eliminates time-consuming, error-prone paper-based documentation. It also reduces the risk of errors and leads to an average 10% of labour savings and reduced product & management review times by 50% or more.
A comprehensive Electronic Batch Record (EBR) that captures complete product genealogy, facilitates review by exception & connects with the anti-counterfeiting serialisation system. Role-based recipe management is optimised for each stage of a recipe lifecycle and drives time to results for every user. A robust solution for data integrity helps ensure that documentation or production human errors do not result in wasted product, contamination or potential recalls.
The objective to achieve for quality assurance and quality control is to use data for predictive models. This allows to have more inline technologies on the floor to provide analytical readouts, faster methods that can pick up trends in real-time and having elements that identify those trends and feed them into the quality system to compare with previous experiences. In this way, the quality team moves away from being focused on records of batches that have already been produced to becoming a business partner to improve processes, as is seen in other industries.
In continuous manufacturing, there is data capture, but now one can use it in the manufacturing process in a predictive way. We are not just learning about the past and reacting to it; we are using it for decision-making and preventive actions in the present. This uses analytics and predictive algorithms. A software platform can store, organise and display data from control systems to automate FDA reporting, present custom reports and ensure quality control. This software platform is a suite of various services, including live data, directory, audit, security, activation and alarm & events.
With easily accessible quality insights, the industry can use analytics to realise proactive process improvements and productivity. With a future-focused information infrastructure in place that brings together IT and OT, key process data is no longer siloed. The industry can collect and analyse real-time data to make better decisions while achieving compliance.
Visualisation technologies for Augmented Reality (AR) provide standard operating procedures directly to the operator. They can also help mitigate downtime events and quickly resolve incidents by doing just this. Appearing right before one’s eyes will be the information needed to assess a machine’s condition or perform a task.
Collect real-time data at centralised data centre from multiple process equipment – Oral solid dosages & sterile equipment machine control system upgradation with respect to hardware, software & IT infrastructure can be offered in formulations units
Different makes of PLC/HMI/SCADA exist in different process equipment – Various existing devices in a network can be aligned by standardisation. Necessary upgradations can be done to meet data integrity requirements
Systems need to comply with 21 CFR Part 11 FDA requirements – Rexel has a wide array of SCADA & HMI products which are 21 CFR Part 11 compliant. Suitable customised software solutions are developed and delivered with its domain experts/solution partners
Centralised data centre will store large amounts of historical data – Software solutions can be offered to collect various machines’ PLC data through Kepware Manufacturing Suite, asset centre software for HMI data pick up and other utilities software for dedicated operator stations. The alarm, process parameters & audit data will be processed in the centralised server with dash boards created on software and a host of other tools will be used to analyse & predict the equipment operations for maintenance & trouble shooting locally or remotely.
Uniform connectivity (like Ethernet) between process equipment & centralised system with plant wide time synchronisation of all machines – The time synchronisation is an essential part of the compliance and all the equipment clocks get synchronised to record universal time in the batch records. This can be done using the Plant NTP server clock & dedicated PLC clock over Ethernet network.
Batch report in pre-defined format
Read Only Client required (sub-area wise) to monitor process equipment
Validation – All the production equipment is validated for its operations & diagnostics provided in the control system
User/operator/maintenance training related to line integration – Training modules for operation, maintenance & troubleshooting can be provided through various software tools and simulation software available in the industry.
Summarising digitisation of pharma manufacturing
Market-leading industrial innovation platform to drive digital transformation for increased operational performance and agility across all pharmaceutical manufacturing
Industry-leading AR development tools to improve workforce efficiency and training
Unified suite integrating production management, analytics, paperless shop floor & execution to drive efficiency across production. We have the opportunity to evolve from a culture of compliance to a culture of quality.