DDE Smarter Solutions Brochure - PPT

1. SmarterSolutions for EnduringValue Design Manufacture Commission Qualify

2. ABOUTUS THE WAYFORWARD We are redefining boundaries in the high purity business while working with sterile formulations, bio-pharmaceuticals, vaccines and MDIindustries. DDE is constantly working to provide smarter technologies, systems and solutions to healthcare companies. For the last 30 years, our focus has been to develop smarter innovations. Today, DDE houses 350+ engineers, technicians, designers, biotechnologists, researchers and experts working at the intersection of technology and healthcare sciencestosolvesomeoftheindustry’stoughestproblems. We have positioned ourselves to be the world’s smart sterile systems manufacturer by envisioning smarter ideas, greener technologies andsolutions. OUR VISION /MISSION To lead the global industrial footprint with distinguished solutions and be a partner in growth for our customers. With exceptional customer focus and astute project management skills our mission is to bring inspiration and ingenuity to everything we engineer. We aim to enhance the credibility and success of our customers throughour reliable path-breaking systems and equipments by being as future-oriented and diversified as the industry in which weoperate. 01

3. ProcessEngineering Automation Qualification &Validation Plan DesignEngineering Training After-SalesSupport Manufacturing SMARTER PROCESSES We are your product custodian Your satisfaction and trust are our performanceparameters. We hearyou Your vision is at the center of our process roadmap. With proactive dialogue and exchange of ideas, we identify critical factors for performance and analyse your requirements. We plan +design Our team of hand-picked experts plan and design your project with highest attention to detail. We propose smart turnkey solutions that are reliable, cost-effective and in compliance with prevalent regulatoryrequirements. We partner throughout the project life cycle Our advanced manufacturing processes involve the industry’s best in class techniques and knowledge accrued over theyears. We implement quality assurance systems for consistency and a thorough check across our manufacturing and automation process to ensure complete aseptic design of our solutions. At DDE, we don’t just execute a project, we ensure highest quality and consistency to deliver smarter solutions for enduringvalue. We understand that creating solutions for any industry’s toughest challenges not only requires current wisdom to be harnessed but also investment insmarter future-proof technologies andprocesses. We partner with you for installing and validating systems to ensure a quick qualification for minimized time tomarket. We work closely with you through your entire manufacturing lifecycle with our training and after- salessupport. Our processes are creating enduring value for our customers and are driving advancements in the domain of protection. This approach is helping us address customer needs more efficiently and effectively. To offer these life saving equipments, we follow all engineering and quality standards. This can be seen through our long-standing association with the world’s best and biggest pharmaceuticalcompanies. Driven by an in-depth understanding and domain expertise, we are contributing to the global pharmaceutical industry to play a pivotal role in improving countlesslives. 02 03

4. SMARTERINDUSTRIES • Bio-pharma • Cell Culture / Microbial / Bio-Enzymes • SterileFormulations • Solutions, Suspensions, Emulsions, Gels for injection, Implants and External applications • mAbs / Biotherapeutics Blood Plasma, Biosimilars / Nutraceuticals,Pro-biotics • Parenteral – Oncology / General Injectables / Complex Injectables- Liposomes / Microspheres / Hormonal / LVP, Ophthalmic, Nasal,Otic. • Vaccines • Viral -Bacterial • Human - Veterinary • MDI (Metered DosageInhaler) • Dry powdered inhaler, Pressurized metered dose inhalers, Nebulizers 04 05

5. SMARTERSOLUTIONS • SterileFormulations • Sterile formulations manufacturers are looking for strong and effective solutions to compound a wide variety of formulations, which include products administered by injection (IV, IM, IP, SC-SQ, ID, intrathecal, epidural) or via otic, intranasal or ophthalmicroutes. • We have decades of experience in developing innovative technologies and smarter solutions for challenging pyrogen free and sterile formulations. • SmarterSystems: • Manufacturing/ Compoundingvessels • Holding/ Filtrationvessels • Filtration skids with Integritytesting • Buffer Vessels for all fillinglines • CIPsystems • SIPsystems • Neutralisation systems/ Inactivationsystems • Integratedsuites • WFIcoolers • Clean steamsampler • Temperature control units(TCUs) • Sterile formulations compounded in our systems including suspensions and emulsions are delivered to end users in a variety of dosage forms including Vial, Ampoule, PFS, Cartridge, FFS/BFS. 06 07

6. SMARTERSOLUTIONS • Bio-pharma |Vaccines • Bio-pharma and vaccine industries require large investment in time and capital to effectively translate scientific discovery into novel and affordabletherapies. • With decades of experience, DDE has become a strategic driver in providing scalable and flexible bioprocess solutions of highquality. • Smarter Systems: • In-Situ Fermenters/Bioreactors • Upstream bioprocess vessels for Media /Buffer preparation, Feed hold, SerumVessels • Transfer sterile filtration skids with Integritytesting • Downstream processing – Harvest Vessels, Pooling Vessels, Buffer preparation, PurificationVessels • TFF/ Cross flow concentrationSkids • Blending/ Formulationsvessels • Product feed vessels for fillingmachine • Integratedsuites • Virus inactivationsystems • Bio-kill/ Decontamination systems - Continuous &Batch • CIP systems – Mobile/Centralized • SIP systems – Integrated/Standalone • Temperature control units(TCUs) • Emergence of new diseases is constantly pushing bio-pharma and vaccine industries to innovate novel therapies and drugs. DDE provides sophisticated and smarter ecosystems to help overcome thesechallenges. 08 09

7. SMARTERSOLUTIONS • MDI /DPI • There has been a significant rise in the prevalence of diseases that are related to the respiratory system such as chronic obstructive pulmonary diseases, asthma, chronic respiratory diseases andothers. • The demand for the metered dose inhalers, Dry powder inhalation and nebulizers hasincreased. • We have vast years of experience in designing and executing standalone and integrated process systems from Pilot to production scale with Vibro Mixers, Top mounted Agitators and Bottom mounted MagneticMixers. • SmarterSystems: • Mixing/ CompoundingVessel • Homogenizing Vessel • API charging ball/ Drug additionvessel • Integratedsuite • Inbuilt or Standalone CIPsystem 10 11

8. EXPERTISE Bio-Pharma | Vaccine | Sterile Formulations | MDI -DPI Our sterile systems are designed to be 100% cleanable and free from dead-leg areas. To ensure that our products offer consistent quality, we use high precision components integrated with a fully automated and intelligent control system and a full cGMP documentationpackage. • Codes, Guidelines andStandards • ASMEBPE • ASME/PED • GAMP • cGMP • FDA, MHRA,WHO • ASMEU-Stamp • 21CFR Part 11compliance • UL • EHEDG • CE • ATEX/ IECEx/ EXd/ EXi/ Exe/FLP • SmartDesign • PFD and P & IDdevelopment • QbD • 3DModelling • Plant equipmentlayouts • AR, VR,MR • Ergonomics • LEAN and LEEDcustomized design • Flexible andModular • Focused pharmaengineering 12 13

9. SMARTERSYSTEMS 14 15

10. SmartQualification • We use a qualification documentation system to monitor commissioning tests (FAT-SAT), optimize non-conformity management, facilitate and speed up reporting processes (review workflow, protocol approval, reports), standardize testprotocols • Qualification is usually carried out by conducting the following activities, individually orcombined • Design Qualification(DQ) • The tests and verification required to be undertaken during commissioningis • documented in ‘Equipment Qualification Plan’ (EQP), which is approved by the end user prior to initiation of IQ & OQactivities. • Installation Qualification (IQ) Documented verification that the equipment or systems are installed or modified • Operational Qualification (OQ) Documented verification that the equipment or systems perform as intended throughout the anticipated operating ranges (an interactive SOP, comes with the IQ/OQ protocol and on completing the requirements specified in the SOP the IQ/OQ protocol iscompleted) • Performance Qualification (PQ) Experienced Commissioning and Performance Qualification (PQ) team has the required technical skills and qualification experience for successful handingover • to the customer to start Performance Qualification activities(PQ) • Smart ProjectExecution • Single point project manager who manages your project from design to delivery. • Project & process engineers are dedicated to implementing the strictest international regulatory requirements. • Highest market expectations met by providing performanceguarantee. • Ensurance of your projects being managed within budget, on time and meeting your exactdeliverables. • SmartInstallation • Installation team consisting of process specialists, automation specialists, technicians, orbital welders andengineers • Highly experienced Process Engineers ensuring quickstart-up • Fully tested skids reassembled at site with Plug n Playdesign • Project management systems combined with our strong on-site managementcapabilities • ensure the proper control of schedule and costs as well as quality of the field installationwork. • Our engineers also partner with the customer’s teams to perform all SAT activities uptoOQ • A well-planned, documented and managed engineering approach is used resulting in a safe and functional environment to meet established design requirements and stakeholder’sexpectations. • SmartFacilities • Dedicated FAT centre with testingbays • which are fully equipped with clean and blackutilities • Static & Dynamic testing of all skids • Fully equipped with instruments and testing equipments to simulate the conditions at the customer’s site • All skids are fully tested andqualified • All pre-FAT reports are available for customers prior to FATvisit 16 17

11. V - MODEL X - MODEL ENGINEERING & AUTOMATION VALIDATION ENGINEERING & AUTOMATION VALIDATION UserRequirements Specifications Performance Qualification(PQ) (Supportonly) User Requirements Specification ValidtionPlan SystemAcceptance (Supportonly) PQ ONSITE FunctionalSpecification Functional Qualification(OQ) SAT Validation Report QualityPlan HW Design Specification Installation Qualification(IQ) Functional Specification Sequences/Recipes HW Integration Test SW IntegrationTest (OQ Protocol andReport) OQ INSTALLATION Functional Testing(OQ) FunctionalSpecification HW Design Specification SW (Module) Design Specification PLC/ OPC/ PCS/ Feldbus/ SCADA/LAN HW Component Acceptance SW ModuleTesting (IQ Protocol andReport) FAT FACTORY IQ HW Design Specification Installation Testing(IQ) HW Construction HWPurchase SWImplementation TopDown BottomUp Engineering, Specification, Pre-Installation at ourfactory 18 19

12. SMARTAUTOMATION 1 2 THIS DRAWING IS THE COPY RIGHT OF D.D.ENTERPRISES. ANY REPRODUCTION IN PART OR WHOLE WITHOUT THE WRITTEN PERMISSION OF DDE ISPROHIBITED. 5 7 3 8 6 4 SYSTEM ARCHITECTURE REDUNDANT SCADA STATION (COMMON FOR ALLSUITES) REDUNDANT PLC SYSTEM (COMMON FOR ALLSUITES) A A FT VIEW SE STATION 250 DISPLAY FT VIEW SE STATION 250 DISPLAY DATABASE SERVER (ASSETCENTERAND FACTORY TALK TRANSACTION MANAGER 5000TAGS) 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-RM2 1756-RM2 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-L74 1756-L74 1756-L74 1756-L74 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-PA75 1756-PA75 OS OS 1756-RMC1-CABLE • PLC/ PCS/ DCS / SCADA, OPC driven systems with remote connectivity and redundancy • SCADA software Supports OPC technology, “Plug & Play” communication, feature-rich GAMP categorysoftwares • Real time data input for MES systems, Alarm & eventnotification • Fully user configurable and upgradeable, Scalable software, Unique customization level and flexible features with local operations via HMI/IPC • Technologically and economically optimizedsolutions • Delivered on Central platform for historians and batchreporting • Can deliver Customized recipes complying to the S-88, GAMP-5 &cGMP • Reliable and seamless integration into existing control strategies & erternal SCADA/MES • Batching systems with eBMR recipe management • Graphics based process automation withloops • Qualification for Software design, Automation hardware Operating platform and softwareinstallation • Unitoperations • Supports most demanding research and productionenvironments • Fully-open automation systems compatible with major solutions from (Siemens, Rockwell, Emerson,etc.) TOSUITE-2 TOSUITE-4 TOSUITE-3 (COMMONFORALLSUITES) HUBERSYSTEM (SUITE-1 &2) GATEWAY PLX32-EIP -MBTCP I/O'S FORHARDWIRE HUBERSYSTEM (SUITE-3 &4) CONNECTION WITH HUBER SYSTEM 5 B B P O R T 1783-BMS20CGL GIGABIT 1734IE4C 1734OE4C 1734AENT MFG.AREA (SUITE-1) MFG.AREA (SUITE-1) MFG.AREA (SUITE-1) MFG.AREA (SUITE-1) CIPAREA(SUITE-1) MFG.AREA (SUITE-1) VALVE GANG -1 5 P O R T VALVE GANG -1 8 P O R T 8 P O R T 8 VALVE 8 P O R T GANG -1 P O R T VALVE GANG -1 LOAD CELL • Recognized Standards &Guidelines • Computer Validation(GAMP5) • Systems Compliance (e.g.21CFR11) • Plant Integration (ISA S95.01 &02) • Batch Control (S88.01 &02) • Interfaces (OPC, B2MML) • Control System Security (ISAS99) • Fieldbuses (IEC 61158) 8 P O R T VALVE GANG -2 C C LOAD CELL 1734AENT 1734IE4C 1734IE2C 1734IE4C 1734IE2C 1734IB4 1734OB4 1734VHSC24 1734IE4C 1734IE2C 1734IB4 1734OB4 1734VHSC24 1734AENT 1734AENT 1734AENT 1734IE4C 1734IB4 1734OB4 1734AENT VALVE GANG -1 RIOPANEL-01 1734IE8C 1734IE2C 1734IB8 1734IB4 1734OB4 1734IE8C 1734IB4 1734OB4 1734AENT AB HMI HMI HMI HMI LOAD CELL VALVE GANG -1 VALVE GANG -2 VFD VFD Powerflex525 Powerflex525 VFD VFD Powerflex525 Powerflex525 VFD 10.4"HMI VFD VFD Powerflex525 Powerflex525 Powerflex525 10.4"HMI 400L JACKETED MANUFACTURINGVESSEL (400L-JMV2-S1/S2)(V4) 20LJACKETED 200L JACKETED 10.4" HMI MANUFACTURINGVESSEL (200L-JMV1-S1)(V7) UTILITYSTATION-01 (044B16-U1-S1)(U1) MANUFACTURING VESSEL 10.4" HMI (20L-JMV5-S1)(V8) 500L-CIP SYSTEM (500L-CIP1-S1/S2 )(CIP1) (SERVICEAREA) MFG. AREA(SUITE-1) MFG. AREA(SUITE-1) MFG.AREA (SUITE-1) FLT.AREA LOAD D D VALVE GANG -1 CELL(SUITE-1) VALVE GANG -1 8 P O R T 8 P O R T VALVE VALVELOAD LOAD VALVE 16 P O R T VFD VFD VFD VFD Powerflex525 Powerflex525 Powerflex525 Powerflex525 VALVE GANG GANGCELL -2-3 16 CELLGANG -2 P O R T GANGVALVE 1734IE8C 1734IE4C 1734IB8 1734OB4 1734VHSC24 1734AENT -1 LOAD CELL GANG -2 1734IE8C 1734IE8C 1734IE2C 1734IB8 1734OB4 1734VHSC24 1734AENT 16 P O R T 1734IE4C 1734IE2C 1734IB4 1734OB4 1734VHSC24 1734AENT 1734AENT 1734IE8C 1734IE8C 1734IB8 1734OB4 1734VHSC24 1734IE4C 1734IE2C 1734IB4 1734OB4 1734AENT VALVE VALVE GANG -1 GANG -1 VALVE GANG -3 AB AB HMI HMI AB LOAD CELL VFD Powerflex525 HMI HMI HMI 10.4"HMI 10.4"HMI VFD Powerflex525 VFD E E Powerflex525 10.4"HMI 10.4"HMI 10.4" HMI 400LJACKETED 1500LJACKETED 750L JACKETED MANUFACTURINGVESSEL VFD Powerflex525 VFD VFD VFD VFD VFDVFD 400L JACKETED MANUFACTURING VESSEL (400L-JMV3-S1/S2)(V2) VFD MANUFACTURING VESSEL 1500L JACKETED FILTRATION VESSEL (400L-JMV4-S1) (V3) (1500L-JFV1-S1)(V6) MANUFACTURINGVESSEL Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525Powerflex525 Powerflex525 (1500L-JMV7-S1)(V5) REFERENCE DRAWINGS NOTE MV7PP-01 (750L-JMV6-S1) (V1) COMMON PANEL FOR VFD(SUITE-1) 02 25.04.2018 NOTE 2 UPDATED SK 01 24.11.2017 REVISED AS PER CLIENT'S COMMENT SMK FV1PP-01 SD AC SD AC SD 00 19.07.2017 ISSUED FOR CLIENT'S APPROVAL PLWAC CHANGESVIACADONLY REV. DATECHANGES DRAWN CHECKEDAPPROVED D. D.ENTERPRISES PLOT NO. 81-B/12 M.I.D.C. BHOSARI, PUNE, MAHARASHTRA, INDIA-411026. 1) P&ID DRG NO :- 044B16-SUT-01-101-001 REV.asb 1) COMMUNICATION CABLEMARKED AS IS IN CUSTOMERSCOPE. 2) P&ID DRG NO :- 044B16-SUT-02-101-001 REV.asb 2) COMMON SCADA WITH OPERATIONAL REDUNDACY FOR SUITE-1, SUITE-2, SUITE-3 AND SUITE-4.OPERATION PROJECT NO.:- FOR ALL SUITES CAN BE PERFORMED FROM BOTHSCADA PCS. DATABASE FOR BATCH REPORT, ALARM, TRENDS AND AUDIT TRAIL WILL BE STORED ON ASSET CENTER PC ONLY.REPORTVIEWORPRINTISPOSSIBLEFROMBOTHSCADAPCS. AUTOBACKUPFROM ASSETCENTERPC TOCLIENTSERVER SHALLBECONFIGUREDON PERIODICBASISSO AS TOENSURETHATDATAWILLNOTEXCEEDDEFINEDLIMITANDOLDDATAWILLNOTBEOVERWRITTEN. DDE 044B16 F F TITLE:- SYSTEM ARCHITECTURE FOR SUITE-1 (AQUEOUS) & SUITE-2(SUSPENSION) SCALE : - NTS QTY. :- 01 SHEET :- 1 OF 5 DRG NO :- 044B16-SUT-01-02-L001 REV :-02 6 7 8 5 1 2 3 4 21 20

13. SMARTERSOLUTIONS • Smart IntegrationServices • Integration of different process systems and packageunits • Multifaceted, integrated automation with OEMsystems • Cross-platformcapabilities • Integrated usersecurity • Data collection to meet regulatory and internalrequirements • Plant-wide future-proofautomation • CIP /SIP/ Process Integration with various OEM’s Processsystems • Handshaking with Controllers of OEM’s processsystems • Control systemaudits • Some of the process system OEMs integrated by usinclude • Smart After Sales and ServiceSupport • Quick telephonic support • Safe remote access in compliance with 21 CFR part11 • Maintenance contract for reliable and cost effective plantplanning • Pre-arranged maintenance visits ensuring Zerodowntime • Recommendedspares • Emergency sparesreplacement • Softwareupgradation • Process and instrumentation support • System modifications, extensions, improvements • Onsite and Onlineservices 22 23

14. BUILDING RELATIONSHIPS WORLDWIDE Our systems are prefabricated with modular designs which can be installed quickly in worldwidelocations. We have the ability to assist your company’s worldwide expansion and look forward to strengthen and build relationships for a smarterfuture. Together we can achieve growth andprofitability. 24

15. Head Office: S- 76/1, M.I.D.C.Bhosari, Pune - 411 026, Maharashtra,India Ph: +91 (20) 2712 2514 / 5 / 6 /7 FactoryAddress: 81- B/12, M.I.D.C.Bhosari, Pune - 411 026, Maharashtra,India Ph: +91 (20) 2712 1631 / 7189| +91 (20) 6611 3189 /90 www.ddentp.com |info@ddentp.com Branch Office: Hyderabad |New Jersey