• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Spark Therapeutics Appoints CTO

    Cryoport Launches ESG Program

    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail

    Thermo Fisher Scientific Completes Mesa Biotech Acquisition

    Ashfield Engage, Popit Form Digital Monitoring Collaboration
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Solid Dose Market Trends

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    C2 Pharma Completes Multiple Regulatory Filings

    Bormioli Opens New Glass Research Center
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Ashfield Engage, Popit Form Digital Monitoring Collaboration

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    CrownBio & JSR Life Sciences Partner with Cambridge Quantum Computing
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Adare Pharma Solutions

    Reed-Lane

    Alcami

    test company saurabh

    Aphena Pharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    PCI Pharma Services

    Emergent BioSolutions

    Almac Group

    Syngene

    Adare Pharma Solutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Features

    Industry 4.0 in the Pharma Industry

    Digitization is not a single-handed project.

    Industry 4.0 in the Pharma Industry
    Related CONTENT
    • Legacy Pharma Solutions
    • PCI Pharma Services
    • Catalent Pharma Solutions
    • MedPharm
    • Regis Custom Pharma
    Dr. Christian Hanisch, Project Manager Industry 4.0 Pharma, Bosch Packaging Technology03.06.19
    From sensors and software to data-based services throughout production, Industry 4.0 solutions are opening new potentials in terms of transparency, quality, safety and efficiency. In the pharmaceutical industry, especially complex processes must be adhered to, and stringent requirements upheld. Nobody can do this alone.

    Humans, machines, processes and IT. In the factory of the future, everything and everyone is connected. Intelligent manufacturing is the answer to a rapidly changing market environment. Products are becoming more individualized, production processes more complex, and batches smaller. Manufacturers can address these challenges by reorienting their production, ensuring that it can quickly and continuously adapt to changing requirements. The basis for the digital transformation lies in the smart use of the virtually boundless amounts of available data. 

    Pharma: a special case
    Compared to many other industries, pharmaceutical production underlies more demanding regulations. Changes to production mean changes to the machines, processes and ultimately the product itself. To ensure consistently high product quality, authorities like the U.S. FDA and the EU Commission issue strict guidelines, such as those on Good Manufacturing Practice (GMP). Accordingly, companies have their fair share of reservations when it comes to implementing new and untried technologies.

    Nevertheless, many pharmaceutical companies have already taken the first step toward digitization and are now engaged in its implementation. In this case, we are talking about serialization based on Track and Trace applications—at least, if a holistic solution is used. To adhere to all relevant legal guidelines, it is not enough to simply print a data matrix code on the folding carton. A holistic serialization and aggregation solution should include the connection between machines and software, ensuring that the entire process can be managed, and the data is constantly available. Only this way manufacturers and distributors alike have a clear overview of all process steps while simultaneously achieving the connectivity that is the hallmark of Industry 4.0.

    Getting started step by step
    The implementation of a serialization solution alone represents a huge challenge. However, in the next step, pharmaceutical companies face obstacles of a very different kind: while Track and Trace applications focus on the packaging, other instruments directly affect the production or filling process. Accordingly, pharmaceutical manufacturers have especially high demands when it comes to new Industry 4.0 solutions. They need the security of knowing that a given solution can be or has already been successfully implemented in the market.

    Digitization projects can influence many processes and components. Hence, no one party can or should try to implement them alone. Instead, digitization is about bundling the respective expertise and experience on a cross-project basis. This can include participating in nationwide initiatives. Above all, however, machine providers, software manufacturers and process experts need to work together closely to reap the maximum benefits of Industry 4.0 for their customers. This does not mean they have to replace their entire machine park or abandon their current production philosophy. A step-by-step approach is often the more sensible alternative.

    Making use of existing competencies
    The first step is to make the existing data visible. For this purpose, Bosch designed its Pharma i 4.0 Starter Edition, which offers machine operators key functions for condition monitoring, event tracking and measuring Overall Equipment Effectiveness (OEE) on their PC or mobile device, including a complete audit trail for all user interactions. No matter whether anomalies or unexpected downtimes occur in the ongoing production, employees can access exactly the information they need, whenever and wherever they like, greatly simplifying their day-to-day work. The data gathered by the software can be subsequently analyzed and used as the basis for targeted process optimizations. This also includes historical data, which can be compared to real-time data and offers valuable insights into the development of central parameters, such as the OEE within a certain timeframe.

    To make this possible, Bosch works with a software partner and applies the software according to the respective customer’s specific situation and needs. Thanks to the use of open standards, incorporating machines and lines from different brands does not mean reinventing the wheel. OPC-UA and the machine programming language PackML are primarily used as the standard for communication and data exchange. Adding further features, for instance the generation of Electronic Batch Records (EBR), is also possible. Here, too, all process steps are subject to strict regulations concerning electronic signatures, GMP-compliant processes and long-term data archiving.

    Finding buried treasure
    Once the data is available, the real challenge consists in identifying previously overlooked information and new potential for optimization. With the help of data analytics or data mining, huge amounts of data are assessed for effects and correlations using statistical methods. Usually, the data from two production batches is sufficient to draw initial conclusions. Yet the more data is evaluated, the more details come to light. The only equipment needed are sensors to gather the data, which can also be found on the majority of older machines, and the right tool for analyzing the data. The most important aspect, however, is the combination of extensive process expertise and IT know-how.

    Here is a real-world example. A pharmaceutical manufacturer suddenly had an “out of specification” (OOS) batch. The data analysis revealed that a certain valve was responsible for the problem. Yet the valve had been ruled out in advance, as it was assumed to have no effect on product quality. The deeper correlations were analyzed, and a previously undetected causal chain became apparent. The analysis ultimately determined that the valve provided indirect evidence of an incorrect gas flow in the system, which would never have been detected otherwise. The problem was then easily solved by recalibrating the system.

    From vision to reality
    In the near future, such recalibrations could be even easier, thanks to Augmented Reality and Virtual Reality (AR and VR). For example, AR applications can guide employees through the process step by step, and be used to display calibration instructions and spare parts. This can considerably accelerate the process without the need for lengthy training. When more complex processes are involved that make training essential, it no longer has to take place in a classroom or on the shopfloor. VR applications produce 3D simulations of machines, which can be used under highly realistic conditions in virtual training sessions. Trainers can follow the simulation live and add helpful instructions as needed, while operators can practice safely and without stress, since any errors they make will have no direct consequences or interrupt the ongoing process.

    Admittedly, some of these Industry 4.0 applications are still in an early stage of development. Nonetheless, the digital future is within our grasp, as essential devices like sensors are getting smaller and smaller, and components are becoming more affordable. To gradually make the vision of a connected pharmaceutical industry a reality in day-to-day production, strong partnerships are called for. After all, the challenges posed by digitization can only be successfully and sustainably overcome if machine manufacturers, software developers, process experts, and employees on the shopfloor work hand in hand. 
    Related Searches
    • Manufacturing
    • training
    • quality
    • serialization
    Suggested For You
    Legacy Pharma Solutions Legacy Pharma Solutions
    PCI Pharma Services PCI Pharma Services
    Catalent Pharma Solutions Catalent Pharma Solutions
    MedPharm MedPharm
    Regis Custom Pharma Regis Custom Pharma
    Reed-Lane Reed-Lane
    Adare Pharma Solutions Adare Pharma Solutions
    Manufacturing Equipment Insights Manufacturing Equipment Insights
    Manufacturing Equipment Technology & Trends Manufacturing Equipment Technology & Trends
    Are We Embracing FDA’s Messages? Are We Embracing FDA’s Messages?
    Manufacturing Equipment Showcase Manufacturing Equipment Showcase
    Aphena Ready for Opioid Crisis Response Act Aphena Ready for Opioid Crisis Response Act
    Akorn Receives FDA Warning Letter Akorn Receives FDA Warning Letter
    Bosch Introduces Sigpack HML Machine Bosch Introduces Sigpack HML Machine
    Janssen Receives FDA Approval for INVOKANA Janssen Receives FDA Approval for INVOKANA

    Related Features

    • Analytical Services | Information Technology | Laboratory Testing
      Business Intelligence For (and From) the Lab

      Business Intelligence For (and From) the Lab

      How a digital ecosystem can harness the most data-rich environment in the CDMO.
      Bob Voelkner, VP Sales and Marketing, LabVantage 01.27.21

    • Clinical Trials | Information Technology | R&D
      Decentralized Trials Fuel AI Revolution in Clinical Research

      Decentralized Trials Fuel AI Revolution in Clinical Research

      The life sciences industry is giving clinical a full makeover, dramatically improving how new therapeutics are developed.
      Nick Moss, Vice President of Analytics and Machine Learning, Medable 11.17.20

    • Clinical Trials | Information Technology
      The Role of Electronic Monitoring in Maintaining Medication Adherence

      The Role of Electronic Monitoring in Maintaining Medication Adherence

      Digital solutions offer hope to get patients to take their medications properly.
      Bernard Vrijens, Scientific Lead, AARDEX Group 10.14.20


    • Information Technology
      You Need Solutions, Digitization is the Answer

      You Need Solutions, Digitization is the Answer

      Cloud technology helps today’s contract manufacturers be agile, transparent and efficient.
      Brian Curran, Senior Vice President of Strategic Growth, MasterControl 10.14.20

    • Information Technology
      Five Ways to Enhance Clinical Operational Efficiencies Utilizing AI

      Five Ways to Enhance Clinical Operational Efficiencies Utilizing AI

      The proven promise and huge potential of using AI and ML to accelerate drug discovery.
      Lucas Glass, Gary Shorter, and Rajneesh Patil, IQVIA 11.20.19

    • Information Technology
      A Brave New World of Data Integrity

      A Brave New World of Data Integrity

      How modern CMOs are keeping up with stringent regulatory guidelines by embracing advanced laboratory information systems.
      Bob Voelkner, VP Sales and Marketing, LabVantage 06.13.19


    • Clinical Trials | Information Technology
      The New Horizon: Metaprise Analytics in Life Sciences

      The New Horizon: Metaprise Analytics in Life Sciences

      Going beyond enterprise analytics to metaprise analytics—patient-centric systems that create a data driven trial team.
      Michelle Longmire, MD, CEO and Founder, Medable 05.07.19

    • Information Technology
      The Manufacturing Revolution In Medicine

      The Manufacturing Revolution In Medicine

      Real-time data insights help both pharma companies and contract manufacturers meet regulatory requirements while ensuring high production standards.
      Petter Moree, OSIsoft, LLC 05.07.19

    • Information Technology
      Digitization: Pharma 4.0

      Digitization: Pharma 4.0

      A look at how technology is impacting the pharma industry
      Fatih Kaya and Gerald Buerkle, Vetter Pharma 01.25.19


    • Information Technology
      FDA & Data Integrity

      FDA & Data Integrity

      FDA Publishes Final Guidance on Data Integrity
      Robert Marohn, Director of Quality Business Systems, Kite Pharmaceutical 01.25.19

    • Information Technology | Serialization | Supply Chain
      Serialization Compliance

      Serialization Compliance

      Automated data controls during packaging help improve compliance.
      Miguel Pitarch, Executive Director, Global Serialization, Bristol-Myers Squibb & the Bristol-Myers Squibb Serialization Team 11.13.18

    • Clinical Trial Materials | Information Technology
      Interactive Response Technology in Clinical Trial Supply

      Interactive Response Technology in Clinical Trial Supply

      Exploring the benefits of including IRT professionals earlier in trial planning
      Dave Holly, Senior Manager, IRT Development and Operations, Sharp Clinical Services 10.10.18


    • Drug Development | Information Technology | R&D
      CRO Industry Update: Big Data Drives Drug Development Efforts

      CRO Industry Update: Big Data Drives Drug Development Efforts

      With growth in virtual trials and RWE, the clinical development landscape may never look the same
      Kristin Brooks, Managing Editor 05.11.18

    • Information Technology | Serialization
      Stripping Serialization Back to Data Integrity

      Stripping Serialization Back to Data Integrity

      Why companies can’t afford to make compromises on quality
      Rachna Mohanka, Sr. Director, Global Solution Consulting, TraceLink 05.08.18

    • Information Technology | Regulatory Affairs
      Data Integrity: A Practical  and Risk-Based Approach

      Data Integrity: A Practical and Risk-Based Approach

      Ways an organization can form a culture and cost-effective means to meet the various challenges in sustaining data integrity.
      Robert Marohn, ClinLogic, LLC 09.06.17

    Trending
    • Catalent Acquires Delphi Genetics
    • Inside A Vaccine Trial
    • Pfizer Selects Seven Bridges To Support RNA Sequencing Data
    • Pfizer Partners With Medicines Manufacturing Innovation Center
    • ICON Acquires Medpass
    Breaking News
    • Spark Therapeutics Appoints CTO
    • Cryoport Launches ESG Program
    • U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    • Thermo Fisher Scientific Completes Mesa Biotech Acquisition
    • Ashfield Engage, Popit Form Digital Monitoring Collaboration
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    ACI Urges Senate to Approve Regan as EPA Administrator
    Estée Lauder Signs Actress Ana de Armas
    GUM Recalls Oral Spray
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login