smart factory, integrated approach and applications of
TRANSCRIPT
2nd Industrial IoT Conference
Digitalization of Manufacturing through Industry 4.0
Smart Factory, Integrated Approach and Applications of Industry 4.0 in Pharma
24th Nov 2018
Ravi K,
Head IT & AI, Anthem Biosciences Group
Tel: +91 9243555508
2014
• IS0 90012008,
• IS0 14001:2004
• BS OHSAS 18001:2007
2006
Company Was Incorporated
2015
Fermentation
AAALAC Accreditation
Apr 2016
GLP
Q2 - 2016
• High Potent Lab
• Solid Phase Peptide Synthesis
• R&D Expansion
Q1-2017
New Commercial Site Operational
2007
Chemistry Services
2013
USFDA Approval
2010 Plant Expansion
2011GMP Authorization
2008Discovery Biology
2009 EU QP Authorisation
2018 USFDA Approval
Chemistry Services
QC / QADiscovery
Biology
Fermentation & Cell Culture
Services
Preclinical Research
Medicinal Chemistry
Library Synthesis
- Natural product inspired virtual compound libraries
Custom Synthesis
Process Chemistry
DoE, QbD concepts
GMP Manufacturing
HiPo suites
Peptides (Solid Phase)
Method Development
Method Validation
API release testing
Stability Studies
Separation Science
Regulatory Support
- e-CTD filing- Open/closed part DMF- IND filing
Platform technologies
Molecular Modeling
Preclinical Biology
Assay Biology
Microbiology
- In vitro studies- In vivo Studies
Preclinical Biology
Efficacy Studies
ADME Studies
Toxicity Studies
In vivo Pharmacology
High density cell cultivation
Low , Medium & High pressure chromatography
Microbial & mammalian cell lines (of fungi, yeast, bacteria, actinomycetes, and mammalian)
Process development & scale up
Product Research /
Development
Pilot Scale Mfg. Bulk Mfg. (API)
Formulations
Pharma Product Cycle
PCR
Regulatory Approval
Discrete & Process Device Comm. Network
Operations Information
Network
Weigh and Dispense
Mixing Granulation Drying Pressing Coating BlisteringCheck and
SealPrint Id &
Expiry
DMS
SCADA Systems Control From SCADA Track and Trace System
ELNSStandalone
systems
Tumble and Tunnel Drying
Rapid Mixing Granulator Fluid Bed Processor
Various Station Compression machine
CVC, Sachet and Blister Packing
Machine.Multiple Packaging
LinesWeighing Scales (WD) Tablet
printing
Automated Inspection systems
L0, L1, L2, L3, L4 defined as per ISA 95 Standards
L3
L1
L2
L5
L4
Gap between manufacturing and Enterprise systems
QMS
ERP
BMS/CMS/EMSQC Systems
Big Data
CPAS/DCS
LIMSQbD
MES
PHARMA Mfg. Flow
Biomarker is a measurable indicator of the severity or presence of some disease
Personalized Medicine
Challenges
Affordability
Compliances
Security Concerns
Sourcing
Support & Services
Integrations
Capabilities
Safety Regulations
Ecosystem availability
Change
Legacy Equipment's
& Applications
Interoperability
Productivity
Product Quality
Equipment Control
Supply Chain
SMART FACTORY OBJECTIVES
Technology Innovations
Networking of Devices
Customers/Suppliers
Regulatory
Technology Transformations
Collaborations
Consumerization
Employees
Previously, “technology was more a barrier than an enabler.” The current technology revolution, “will allow manufacturers to get closer to their supply chains and plants.”
Technology Trends
Continuous Mfg.
Paperless Mfg.
Big Data & Analytics
Predictive & Prescriptive
Analysis
Intelligent Devices
Simulation
Personalized Mfg
3D Printing
AI, Augmented, VR
Traditional Mfg. VS Continuous Mfg..
CP Factory partner facility
The factory of the future
16
Mechatronic systems are turning into cyber-physical systems
+ IP capacity
+ Internet communication+ machine-to-machine communication• Wireless communication• Semantic description
+ sensors, actuators+ integrated intelligence
The Internet of things
Cyber-physical systems
Integrated systems
Physical objects, devices
Sensors
IP address, controller platform
Valves
Paperless Office
Integrated work flow
R&D, Pilot Plant, Bulk Mfg.ELN ,E-BMR Integrated LIMS
Integrated IT & OT
Personalized Alarm
ManagementIntegrated Alarm &
Condition Monitoring
Integrated QMS
Integrated Automation
Electronic
Continuous Mfg.
PAT Continuous Quality
VerificationSmaller Foot Print
Reducing wasteSignificant savings
Flexible Mfg.
Improved yield with better quality
Reduced CIP
Cost Savings
Efficient Usage
Single use & Flexible Mfg.
Compliances
M2M , M2P, M2L
M2M Communication Condition Monitoring Modeling, Predictive & Control(MPC)
Work Flow Deviations/Quality AspectsBatch Progress
Machine to People Interaction
Electronic Review Intelligent
Reliability Planning
Reporting
ANTHEM SMART FACTORY
ANTHEM SMART FACTORY ARCHITECTURE
Advantages of Integrated Automation & Virtualization
Operator Convenience
Remote Control
High Availability
Easy to collaborate
Less Maintenance Efforts
Significant Savings
Operator Safety
E-audits
Integrated Control
Integrated Alarm
Management
Reliability Regulatory compliance
Fermentation Upstream
BMS
API
FermentationDownstream
PEMS
Integrated Automation
Control Process Automation SystemsDTS/DMS
LIMS/QC
Quality Assurance
Utility Data & BMS
Labs Knowledge Portal
DMZ Delivery Controllers Apps & DataResource Location
Service ManagementMonitoring Analytics Automation Provisioning
Virtual Desktops
Virtual Applications
Enterprise Mobility Management
File Sync and Sharing
Desktops
Windows Apps
Secure Browser
SaaS & Web Apps
Mobile Apps
Data
On-premises
Hybrid Cloud
Cloud (Public or Private)
Application Delivery
Networking
