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DDE_Brochure | CIP SIP System

DDE is constantly working to provide smarter technologies, systems and solutions to healthcare companies.

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DDE_Brochure | CIP SIP System

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  1. Smarter Solutions for Enduring Value Design Manufacture Commission Qualify

  2. ABOUT US THE WAY FORWARD 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 sciences to solve some of the industry’s toughest problems. We are redefining boundaries in the high purity business while working with sterile formulations, bio-pharmaceuticals, vaccines and MDI industries. We have positioned ourselves to be the world’s smart sterile systems manufacturer by envisioning smarter ideas, greener technologies and solutions. 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 through our reliable path-breaking systems and equipments by being as future-oriented and diversified as the industry in which we operate. 01

  3. Process Engineering Process Engineering Automation Automation Qualification & Validation & Validation Qualification Plan Plan Design Engineering Design Engineering Training Training After-Sales Support After-Sales Support Manufacturing SMARTER PROCESSES SMARTER PROCESSES We hear you 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 implement quality assurance systems for consistency and a thorough check across our manufacturing and automation process to ensure complete aseptic design of our solutions . We are your product custodian Your satisfaction and trust are our performance parameters. performance parameters. We are your product custodian Your satisfaction and trust are our At DDE, we don’t just execute a project, we ensure highest quality and consistency to deliver smarter solutions for enduring value. for enduring value. At DDE, we don’t just execute a project, we ensure highest quality and consistency to deliver smarter solutions We understand that creating solutions for any industry’s toughest challenges not only requires current wisdom to be harnessed but also investment in smarter future-proof technologies and processes. future-proof technologies and processes. We understand that creating solutions for industry’s toughest challenges not only requires current wisdom to be harnessed but also investment in smarter We partner with you for installing and validating systems to ensure a quick qualification for minimized time to market. 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 regulatory requirements. We work closely with you through your entire manufacturing lifecycle with our training and after- sales support. 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. effectively. 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 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 pharmaceutical companies. We partner throughout the project life cycle Our advanced manufacturing processes involve the industry’s best in class techniques and knowledge accrued over the years. Driven by an in-depth understanding and domain expertise, we are contributing to the global pharmaceutical industry to play a pivotal role in improving countless lives. a pivotal role in improving countless lives. Driven by in-depth understanding and domain expertise, we are contributing to the global pharmaceutical industry to play 02 02 03

  4. SMARTER INDUSTRIES Bio-pharma Sterile Formulations • Cell Culture / Microbial / Bio-Enzymes • 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 Vaccines • Viral - Bacterial • Human - Veterinary MDI (Metered Dosage Inhaler) • Dry powdered inhaler, Pressurized metered dose inhalers, Nebulizers 04 04 05

  5. SMARTER SOLUTIONS SMARTER SOLUTIONS Sterile Formulations Sterile Formulations 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 ophthalmic routes. intranasal or ophthalmic routes. 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, We have decades of experience in developing innovative technologies and smarter solutions for challenging pyrogen free and sterile formulations. formulations. We have decades of experience in developing innovative technologies and smarter solutions for challenging pyrogen free and sterile Smarter Systems: • Manufacturing/ Compounding vessels • Holding/ Filtration vessels • Filtration skids with Integrity testing • Buffer Vessels for all filling lines • CIP systems • SIP systems • Neutralisation systems/ Inactivation systems • Integrated suite • WFI coolers • Clean steam sampler • Temperature control units (TCUs) • Temperature control units (TCUs) Smarter Systems: • Manufacturing/ Compounding vessels • Holding/ Filtration vessels • Filtration skids with Integrity testing • Buffer Vessels for all filling lines • CIP systems • SIP systems • Neutralisation systems/ Inactivation systems • Integrated suites • WFI coolers • Clean steam sampler 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. Cartridge, FFS/ BFS. 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, 06 06 07 07

  6. SMARTER SOLUTIONS Bio-pharma | Vaccines Bio-pharma and vaccine industries require large investment in time and capital to effectively translate scientific discovery into novel and affordable therapies. SMARTER SOLUTIONS With decades of experience, DDE has become a strategic driver in providing scalable and flexible bioprocess solutions of high quality. Bio-pharma | Vaccines Smarter Systems: • In-Situ Fermenters/ Bioreactors • Upstream bioprocess vessels for Media /Buffer Bio-pharma and vaccine industries require large investment in time and capital to effectively translate scientific discovery into novel and affordable therapies. preparation, Feed hold, Serum Vessels • Transfer sterile filtration skids with Integrity testing • Downstream processing – Harvest Vessels, Pooling Vessels, Buffer preparation, Purification Vessels • TFF/ Cross flow concentration Skids • Blending/ Formulations vessels • Product feed vessels for filling machine • Integrated suites • Virus inactivation systems • Bio-kill/ Decontamination systems - Continuous & Batch • CIP systems – Mobile/ Centralized • SIP systems – Integrated/ Standalone • Temperature control units (TCUs) With decades of experience, DDE has become a strategic driver in providing scalable and flexible bioprocess solutions of high quality. Smarter Systems: • In-Situ Fermenters/ Bioreactors • Upstream bioprocess vessels for Media /Buffer preparation, Feed hold, Serum Vessels • Transfer sterile filtration skids with Integrity testing • Downstream processing – Harvest Vessels, Pooling Vessels, Buffer preparation, Purification Vessels • TFF/ Cross flow concentration Skids • Blending/ Formulations vessels • Product feed vessels for filling machine • Integrated suites • Virus inactivation systems • Bio-kill/ Decontamination systems - Continuous & Batch • CIP systems – Mobile/ Centralized • SIP systems – Integrated/ Standalone • Temperature control units (TCUs) overcome these challenges. 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 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 these challenges. 08 08 09

  7. SMARTER SOLUTIONS SMARTER SOLUTIONS MDI / DPI MDI / DPI There has been a significant rise in the prevalence of the diseases that are related to the respiratory system such as chronic obstructive pulmonary diseases, asthma, chronic respiratory diseases and others. and others. 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 The demand for the metered dose inhalers, Dry powder inhalation and nebulizers has increased. nebulizers has increased. The demand for the metered dose inhalers, Dry powder inhalation and 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 Magnetic Mixers. mounted Magnetic Mixers. 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 Smarter Systems: • Mixing/ Compounding Vessel • Homogenizing Vessel • API charging ball/ Drug addition vessel • Integrated suite • Inbuilt or Standalone CIP system • Inbuilt or Standalone CIP system Smarter Systems: • Mixing/ Compounding Vessel • Homogenizing Vessel • API charging ball/ Drug addition vessel • Integrated suite 10 10 11

  8. EXPERTISE Bio-Pharma | Vaccine | Sterile Formulations | MDI - DPI Codes, Guidelines and Standards • ASME BPE • ASME/PED • GAMP • cGMP • FDA, MHRA, WHO • ASME U-Stamp • 21CFR Part 11 compliance • UL • EHEDG • CE • ATEX/ IECEx/ EXd/ EXi/ Exe/ FLP Smart Design • PFD and P & ID development • QbD • 3D Modelling • Plant equipment layouts • AR, VR, MR • Ergonomics • LEAN and LEED customized design • Flexible and Modular • Focused pharma engineering 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 documentation package. 12 13

  9. SMARTER SYSTEMS 14 14 15

  10. Smart Project Execution Smart Qualification Smart Qualification Smart Installation • 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 test protocols • Qualification is usually carried out by conducting the following activities, individually or combined •Design Qualification (DQ) The tests and verification required to be undertaken during commissioning is documented in ‘Equipment Qualification Plan’ (EQP), which is approved by the end user prior to initiation of IQ & OQ activities. • 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 is completed) • Performance Qualification (PQ) Experienced Commissioning and Performance Qualification (PQ) team has the required technical skills and qualification experience for successful handing over • 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 test protocols • Qualification is usually carried out by conducting the following activities, individually or combined • Design Qualification (DQ) • The tests and verification required to be undertaken during commissioning is documented in ‘Equipment Qualification Plan’ (EQP), which is approved by the end user prior to initiation of IQ & OQ activities. • 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 is completed) • Experienced Commissioning and Qualification team has the required technical skills and qualification experience for successful handing over to the customer to start Process Qualification activities ( PQ ) to the customer to start Performance Qualification activities (PQ) • Installation team consisting of process specialists, automation specialists, technicians, orbital welders and engineers • Highly experienced Process Engineers ensuring quick start-up • Fully tested skids reassembled at site with Plug n Play design • Project management systems combined with our strong on-site management capabilities ensure the proper control of schedule and costs as well as quality of the field installation work. • Our engineers also partner with the customer’s teams to perform all SAT activities upto OQ • A well-planned, documented and managed engineering approach is used resulting in a safe and functional environment to meet established design requirements and stakeholder’s expectations. • 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 performance guarantee. • Ensurance of your projects being managed within budget, on time and meeting your exact deliverables. Smart Facilities • Dedicated FAT centre with testing bays which are fully equipped with clean and black utilities • 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 and qualified • All pre-FAT reports are available for customers prior to FAT visit 16 16 17

  11. X - MODEL V - MODEL ENGINEERING & AUTOMATION VALIDATION ENGINEERING & AUTOMATION VALIDATION Performance Qualification (PQ) Performance Qualification (PQ) (Support only) (Support only) User Requirements Specifications Specifications User Requirements User Requirements Specification Validtion Plan PQ System Acceptance (Support only) ONSITE ONSITE Functional Qualification (OQ) Qualification (OQ) Functional Functional Specification Functional Specification Validation Report Quality Plan SAT SAT HW Design Specification Specification HW Design Installation Qualification (IQ) Qualification (IQ) Installation HW Integration Test SW Integration Test (OQ Protocol and Report) Functional Specification Sequences/ Recipes OQ INSTALLATION INSTALLATION Functional Specification Functional Specification Functional Testing (OQ) Functional Testing (OQ) HW Design Specification SW (Module) Design Specification PLC/ OPC/ PCS/ Feldbus/ SCADA/ LAN HW Component Acceptance SW Module Testing (IQ Protocol and Report) FACTORY FACTORY IQ FAT FAT HW Design Specification Specification HW Design Installation Testing (IQ) Installation Testing (IQ) HW Construction HW Purchase SW Implementation Top Down Bottom Up Engineering, Specification, Pre-Installation at our factory Pre-Installation at our factory Engineering, Specification, 18 19 19

  12. SMART AUTOMATION 5 5 7 7 1 1 3 3 6 6 8 8 2 2 4 4 THIS DRAWING IS THE COPY RIGHT OF D.D.ENTERPRISES. ANY REPRODUCTION IN PART OR WHOLE WITHOUT THE WRITTEN PERMISSION OF DDE IS PROHIBITED. PART OR WHOLE WITHOUT THE WRITTEN PERMISSION OF DDE IS PROHIBITED. SYSTEM ARCHITECTURE REDUNDANT SCADA STATION (COMMON FOR ALL SUITES) REDUNDANT PLC SYSTEM (COMMON FOR ALL SUITES) REDUNDANT PLC SYSTEM (COMMON FOR ALL SUITES) A A A DATABASE SERVER (ASSET CENTER AND FACTORY TALK TRANSACTION MANAGER DATABASE SERVER (ASSET CENTER AND FACTORY TALK TRANSACTION MANAGER 5000 TAGS) 5000 TAGS) FT VIEW SE STATION 250 DISPLAY FT VIEW SE STATION 250 DISPLAY 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-RM2 1756-RM2 1756-RM2 1756-RM2 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-EN2T 1756-L74 1756-L74 1756-L74 1756-L74 1756-L74 1756-L74 1756-L74 1756-L74 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-N2 1756-PA75 1756-PA75 1756-PA75 1756-PA75 OS OS 1756-RMC1-CABLE 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 category softwares • Real time data input for MES systems, Alarm & event notification • Fully user configurable and upgradeable, Scalable software, Unique customization level and flexible features with local operations via HMI/ IPC • Technologically and economically optimized solutions • Delivered on Central platform for historians and batch reporting • 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 with loops • Qualification for Software design, Automation hardware Operating platform and software installation • Unit operations • Supports most demanding research and production environments • Fully-open automation systems compatible with major solutions from (Siemens, Rockwell, Emerson, etc.) TO SUITE-2 TO SUITE-4 TO SUITE-3 TO SUITE-2 TO SUITE-4 (COMMON FOR ALL SUITES) (COMMON FOR ALL SUITES) HUBER SYSTEM (SUITE-1 & 2) GATEWAY PLX32-EIP -MBTCP -MBTCP GATEWAY PLX32-EIP TO SUITE-3 I/O'S FOR HARDWIRE CONNECTION WITH HUBER SYSTEM CONNECTION WITH HUBER SYSTEM I/O'S FOR HARDWIRE HUBER SYSTEM (SUITE-3 & 4) (SUITE-3 & 4) HUBER SYSTEM B B 5 P O R 5 P O R T T 1783-BMS20CGL GIGABIT GIGABIT 1783-BMS20CGL 1734 OE4C 1734 AENT 1734 IE4C MFG. AREA (SUITE-1) (SUITE-1) MFG. AREA MFG. AREA MFG. AREA (SUITE-1) (SUITE-1) MFG. AREA (SUITE-1) (SUITE-1) MFG. AREA MFG. AREA MFG. AREA (SUITE-1) (SUITE-1) CIP AREA(SUITE-1) MFG. AREA (SUITE-1) (SUITE-1) MFG. AREA VALVE GANG VALVE GANG -1 -1 5 P O R T T 5 P O R VALVE GANG -1 -1 VALVE GANG 8 P O R T T 8 P O R 8 P O R 8 P O R T T 8 P O R T T 8 P O R VALVE GANG -1 -1 VALVE GANG 8 P O R 8 P O R T T VALVE GANG -1 -1 VALVE GANG Recognized Standards & Guidelines LOAD LOAD CELL CELL 8 P O R T T 8 P O R VALVE GANG -2 -2 VALVE GANG C C LOAD CELL CELL LOAD 1734 AENT 1734 AENT 1734 IE4C 1734 IE4C 1734 IE2C 1734 IE2C 1734 VHSC24 1734 VHSC24 1734 VHSC24 1734 VHSC24 1734 AENT 1734 AENT 1734 IE4C 1734 IE4C 1734 AENT 1734 AENT 1734 AENT 1734 AENT 1734 IE2C 1734 IE2C 1734 OB4 1734 OB4 1734 IE4C 1734 IE4C 1734 IE2C 1734 IE2C 1734 IE4C 1734 IE4C 1734 OB4 1734 OB4 1734 OB4 1734 OB4 1734 IB4 1734 IB4 1734 IB4 1734 IB4 1734 IB4 1734 IB4 1734 AENT VALVE GANG -1 -1 VALVE GANG 1734 IE8C 1734 IE2C 1734 OB4 1734 IB8 1734 IB4 RIO PANEL-01 RIO PANEL-01 1734 IE8C 1734 IE8C 1734 AENT 1734 AENT 1734 OB4 1734 OB4 1734 IB4 1734 IB4 AB AB AB AB AB AB AB HMI HMI LOAD LOAD CELL CELL HMI HMI HMI HMI HMI VALVE GANG -1 -1 VALVE GANG VALVE GANG -2 -2 VALVE GANG VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD Powerflex525 Powerflex525 Powerflex525 Powerflex525 VFD Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 10.4" HMI 10.4" HMI Powerflex525 400L JACKETED MANUFACTURING VESSEL (400L-JMV2-S1/S2) (V4) (400L-JMV2-S1/S2) (V4) 400L JACKETED MANUFACTURING VESSEL 20L JACKETED MANUFACTURING VESSEL 20L JACKETED MANUFACTURING VESSEL (20L-JMV5-S1) (V8) (20L-JMV5-S1) (V8) 200L JACKETED MANUFACTURING VESSEL (200L-JMV1-S1) (V7) (200L-JMV1-S1) (V7) 200L JACKETED MANUFACTURING VESSEL Powerflex525 10.4" HMI 10.4" HMI 10.4" HMI 10.4" HMI 10.4" HMI UTILITY STATION-01 (044B16-U1-S1) (U1) (044B16-U1-S1) (U1) UTILITY STATION-01 500L-CIP SYSTEM (500L-CIP1-S1/S2 ) (CIP1) 500L-CIP SYSTEM (500L-CIP1-S1/S2 ) (CIP1) • 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 (ISA S99) • Fieldbuses (IEC 61158) (SERVICE AREA) (SERVICE AREA) MFG. AREA (SUITE-1) MFG. AREA (SUITE-1) MFG. AREA (SUITE-1) MFG. AREA (SUITE-1) MFG. AREA MFG. AREA (SUITE-1) (SUITE-1) FLT. AREA FLT. AREA (SUITE-1) (SUITE-1) D D VALVE GANG VALVE GANG -1 -1 LOAD LOAD CELL CELL VALVE GANG -1 -1 VALVE GANG 8 P O R 8 P O R T T 8 P O R 8 P O R T T VALVE GANG -2 -2 VALVE GANG VALVE GANG -3 -3 VALVE GANG VALVE GANG VALVE GANG -2 -2 LOAD CELL CELL LOAD LOAD LOAD CELL CELL 16 P O R T T 16 P O R VALVE GANG VALVE GANG -1 -1 16 P O R 16 P O R T T VFD VFD VFD VFD VFD VFD VFD VFD VALVE GANG -2 -2 VALVE GANG Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 1734 VHSC24 1734 VHSC24 1734 AENT 1734 AENT 1734 IE8C 1734 IE8C 1734 IE4C 1734 IE4C 1734 OB4 1734 OB4 LOAD LOAD CELL CELL 1734 VHSC24 1734 VHSC24 1734 IB8 1734 IB8 1734 AENT 1734 AENT 1734 IE8C 1734 IE8C 1734 IE8C 1734 IE8C 1734 IE2C 1734 IE2C 1734 OB4 1734 OB4 1734 IB8 1734 IB8 16 P O R 16 P O R T T 1734 VHSC24 1734 VHSC24 1734 AENT 1734 AENT 1734 AENT 1734 AENT 1734 VHSC24 1734 VHSC24 1734 IE2C 1734 IE2C 1734 IE2C 1734 IE2C 1734 IE4C 1734 IE4C 1734 IE4C 1734 IE4C 1734 AENT 1734 AENT 1734 OB4 1734 OB4 1734 OB4 1734 OB4 VALVE GANG -1 -1 VALVE GANG VALVE GANG -1 -1 VALVE GANG 1734 IE8C 1734 IE8C 1734 IE8C 1734 IE8C 1734 OB4 1734 OB4 1734 IB4 1734 IB4 1734 IB4 1734 IB4 1734 IB8 1734 IB8 VALVE GANG -3 -3 VALVE GANG AB AB AB AB HMI HMI HMI HMI AB AB AB AB AB AB LOAD LOAD CELL CELL HMI HMI HMI HMI HMI HMI VFD VFD 10.4" HMI 10.4" HMI Powerflex525 Powerflex525 10.4" HMI 10.4" HMI VFD VFD VFD VFD E E Powerflex525 Powerflex525 Powerflex525 Powerflex525 10.4" HMI 10.4" HMI 10.4" HMI 10.4" HMI 10.4" HMI 400L JACKETED MANUFACTURING VESSEL (400L-JMV3-S1/S2) (V2) (400L-JMV3-S1/S2) (V2) 10.4" HMI 400L JACKETED MANUFACTURING VESSEL 400L JACKETED MANUFACTURING VESSEL 400L JACKETED MANUFACTURING VESSEL (400L-JMV4-S1) (V3) (400L-JMV4-S1) (V3) 1500L JACKETED MANUFACTURING VESSEL 1500L JACKETED MANUFACTURING VESSEL (1500L-JMV7-S1) (V5) (1500L-JMV7-S1) (V5) 750L JACKETED MANUFACTURING VESSEL (750L-JMV6-S1) (V1) (750L-JMV6-S1) (V1) 750L JACKETED MANUFACTURING VESSEL VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD VFD 1500L JACKETED FILTRATION VESSEL 1500L JACKETED FILTRATION VESSEL (1500L-JFV1-S1) (V6) (1500L-JFV1-S1) (V6) Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 Powerflex525 COMMON PANEL FOR VFD (SUITE-1) COMMON PANEL FOR VFD (SUITE-1) MV7PP-01 MV7PP-01 FV1PP-01 FV1PP-01 25.04.2018 25.04.2018 SD NOTE 2 UPDATED NOTE 2 UPDATED SK AC 02 02 24.11.2017 REVISED AS PER CLIENT'S COMMENT 24.11.2017 REVISED AS PER CLIENT'S COMMENT SD SMK AC 01 19.07.2017 19.07.2017 PLW AC SD 00 ISSUED FOR CLIENT'S APPROVAL ISSUED FOR CLIENT'S APPROVAL NOTE NOTE REFERENCE DRAWINGS CHANGES VIA CAD ONLY CHANGES VIA CAD ONLY CHANGES CHANGES D. D. ENTERPRISES PLOT NO. 81-B/12 M.I.D.C. BHOSARI, PUNE, MAHARASHTRA, INDIA-411026. DRAWN CHECKED APPROVED DRAWN CHECKED APPROVED DATE DATE REV. REV. 1) 1) 2) 2) COMMUNICATION CABLE MARKED AS IS IN CUSTOMER SCOPE. COMMON SCADA WITH OPERATIONAL REDUNDACY FOR SUITE-1, SUITE-2, SUITE-3 AND SUITE-4. OPERATION FOR ALL SUITES CAN BE PERFORMED FROM BOTH SCADA PCS. DATABASE FOR BATCH REPORT, ALARM, TRENDS AND AUDIT TRAIL WILL BE STORED ON ASSET CENTER PC ONLY. REPORT VIEW OR PRINT IS POSSIBLE FROM BOTH SCADA PCS. AUTO BACKUP FROM ASSET CENTER PC TO CLIENT SERVER SHALL BE CONFIGURED ON PERIODIC BASIS SO AS TO ENSURE THAT DATA WILL NOT EXCEED DEFINED LIMIT AND OLD DATA WILL NOT BE OVERWRITTEN. TO ENSURE THAT DATA WILL NOT EXCEED DEFINED LIMIT AND OLD DATA WILL NOT BE OVERWRITTEN. COMMUNICATION CABLE MARKED AS IS IN CUSTOMER SCOPE. COMMON SCADA WITH OPERATIONAL REDUNDACY FOR SUITE-1, SUITE-2, SUITE-3 AND SUITE-4. OPERATION FOR ALL SUITES CAN BE PERFORMED FROM BOTH SCADA PCS. DATABASE FOR BATCH REPORT, ALARM, TRENDS AND AUDIT TRAIL WILL BE STORED ON ASSET CENTER PC ONLY. REPORT VIEW OR PRINT IS POSSIBLE FROM BOTH SCADA PCS. AUTO BACKUP FROM ASSET CENTER PC TO CLIENT SERVER SHALL BE CONFIGURED ON PERIODIC BASIS SO AS 1) 2) 2) 1) P&ID DRG NO :- 044B16-SUT-01-101-001 REV.asb P&ID DRG NO :- 044B16-SUT-01-101-001 REV.asb P&ID DRG NO :- 044B16-SUT-02-101-001 REV.asb P&ID DRG NO :- 044B16-SUT-02-101-001 REV.asb PROJECT NO. :- PROJECT NO. :- DDE DE PLOT NO. 81-B/12 M.I.D.C. BHOSARI, PUNE, MAHARASHTRA, INDIA-411026. 044B16 044B16 F F TITLE :- TITLE :- SYSTEM ARCHITECTURE FOR SUITE-1 (AQUEOUS) & SYSTEM ARCHITECTURE FOR SUITE-1 (AQUEOUS) & SUITE-2 (SUSPENSION) SUITE-2 (SUSPENSION) SHEET :- 1 OF 5 SHEET :- 1 OF 5 QTY. :- QTY. :- DRG NO :- 044B16-SUT-01-02-L001 DRG NO :- 044B16-SUT-01-02-L001 SCALE : - NTS 6 SCALE : - NTS REV :- 02 REV :- 02 01 01 5 7 1 2 3 4 8 8 20 06 21

  13. SMARTER SOLUTIONS SMARTER SOLUTIONS Smart Integration Services Smart Integration Services • Integration of different process systems and package units • Multifaceted, integrated automation with OEM systems • Cross-platform capabilities • Integrated user security • Data collection to meet regulatory and internal requirements • Plant-wide future-proof automation • CIP /SIP/ Process Integration with various OEM’s Process systems • Handshaking with Controllers of OEM’s process systems • Control system audits • Integration of different process systems and package units • Multifaceted, integrated automation with OEM systems • Cross-platform capabilities • Integrated user security • Data collection to meet regulatory and internal requirements • Plant-wide future-proof automation • CIP /SIP/ Process Integration with various OEM’s Process systems • Handshaking with Controllers of OEM’s process systems • Control system audits • Some of the process system OEMs integrated by us include Smart After Sales and Service Support Service Support Smart After Sales and • Quick telephonic support • Safe remote access in compliance with 21 CFR part 11 • Maintenance contract for reliable and cost effective plant planning • Pre-arranged maintenance visits ensuring Zero downtime • Recommended spares • Emergency replacement • Software upgradation • Process and instrumentation support • System modifications, extensions, improvements • Onsite service/ service at our work • Onsite and Online services • Quick telephonic support • Safe remote access in compliance with 21 CFR part 11 • Maintenance contract for reliable and cost effective plant planning • Pre-arranged maintenance visits ensuring Zero downtime • Recommended spares • Emergency spares replacement • Software upgradation • Process and instrumentation support • System modifications, extensions, improvements 22 06 23

  14. BUILDING RELATIONSHIPS WORLDWIDE Our systems are prefabricated with modular designs which can be installed quickly in worldwide locations. We have the ability to assist your company’s worldwide expansion and look forward to strengthen and build relationships for a smarter future. Together we can achieve growth and profitability. 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 Factory Address: 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

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