smarter solutions for enduring value · products administered by injection (iv, im, ip, sc-sq, id,...

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Smarter Solutions for Enduring Value

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.

ABOUT US

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.

OUR VISION / MISSION

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.

THE WAY FORWARD

01

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.

ABOUT US

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.

OUR VISION / MISSION

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.

THE WAY FORWARD

01

SMARTER PROCESSES

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.

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.

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.

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 partner with you for installing and validating systems to ensure a quick qualification for minimized time to market.

We work closely with you through your entire manufacturing lifecycle with our training and after- sales support.

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.

Plan

Design Engineering

Process Engineering Automation

Qualification & Validation

Training

After-Sales SupportManufacturing

We hear youYour 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 regulatory requirements.

We partner throughout the project life cycleOur advanced manufacturing processes involve the industry’s best in class techniques and knowledge accrued over the years.

We are your product custodianYour satisfaction and trust are our performance parameters.

At DDE, we don’t just execute a project, we ensure highest quality and consistency to deliver smarter solutions for enduring value.

02 03

SMARTER PROCESSES

We understand that creating solutions for industry’s toughest challenges not only requires current wisdom to be harnessed but also investment in smarter future-proof technologies and processes.

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.

Driven by in-depth understanding and domain expertise, we are contributing to the global pharmaceutical industry to play a pivotal role in improving countless lives.

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 partner with you for installing and validating systems to ensure a quick qualification for minimized time to market.

We work closely with you through your entire manufacturing lifecycle with our training and after- sales support.

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 hear youYour 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 of prevalent regulatory requirements.

We partner throughout the project life cycleOur advanced manufacturing processes involve the industry’s best in class techniques and knowledge accrued over the years.

We are your product custodianYour satisfaction and trust are our performance parameters.

At DDE, we don’t just execute a project, we ensure highest quality and consistency to deliver smarter solutions for enduring value.

02 03

Plan

Design Engineering


Manufacturing

Plan

Design Engineering


Qualification & Validation

Training

After-Sales Support

Bio-pharma

Sterile Formulations

MDI (Metered Dosage Inhaler)

• Cell Culture / Microbial / Bio-Enzymes

• mAbs / Biotherapeutics Blood Plasma, biosimilars / Nutraceuticals, Pro-biotics

• Viral - Bacterial• Human - Vetenirary,

• Solutions, Suspensions, Emulsions, Gels for injection, Implants and External applications

• Parenteral – Oncology / General Injectables / Complex Injectables- Liposomes / Microspheres / Hormonal / LVP, Ophthalmic, Nasal, Otic.

• Dry powdered inhaler, Pressurized metered dose inhalers, Nebulizers

SMARTER INDUSTRIES

Vaccines

04 05

Bio-pharma


MDI (Metered Dosage Inhaler)

• Cell Culture / Microbial / Bio-Enzymes

• mAbs / Biotherapeutics Blood Plasma, Biosimilars / Nutraceuticals, Pro-biotics

• Viral - Bacterial• Human - Veterinary

• Solutions, Suspensions, Emulsions, Gels for injection, Implants and External applications

• Parenteral – Oncology / General Injectables / Complex Injectables- Liposomes / Microspheres / Hormonal / LVP, Ophthalmic, Nasal, Otic.

• Dry powdered inhaler, Pressurized metered dose inhalers, Nebulizers

SMARTER INDUSTRIES

Vaccines

04 05

06 07

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.

We have decades of experience in developing innovative technologies and smarter solutions for challenging pyrogen free and sterile formulations.

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)

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.


SMARTER SOLUTIONS

06 07

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.

We have decades of experience in developing innovative technologies and smarter solutions for challenging pyrogen free and sterile formulations.

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• 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.


SMARTER SOLUTIONS

Bio-pharma and vaccine industries require large investment in time and capital to effectively translate scientific discovery into novel and affordable therapies.

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)

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.

Bio-pharma | Vaccines

SMARTER SOLUTIONS

08 0908 09

Bio-pharma and vaccine industries require large investment in time and capital to effectively translate scientific discovery into novel and affordable therapies.

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)

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.

Bio-pharma | Vaccines

SMARTER SOLUTIONS

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.

The demand for the metered dose inhalers, Dry powder inhalation and nebulizers has increased.

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.

Smarter Systems:• Mixing/ Compounding Vessel• Homogenizing Vessel• API charging ball/ Drug addition vessel• Integrated suite• Inbuilt or Standalone CIP system

MDI / DPI

SMARTER SOLUTIONS

10 11

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 and others.

The demand for the metered dose inhalers, Dry powder inhalation and nebulizers has increased.

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.

Smarter Systems:• Mixing/ Compounding Vessel• Homogenizing Vessel• API charging ball/ Drug addition vessel• Integrated suite• Inbuilt or Standalone CIP system

MDI / DPI

SMARTER SOLUTIONS

10 11

12 13

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.

Bio-Pharma | Vaccine |Sterile Formulations |MDI - DPI

EXPERTISE

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

14 15

SMARTER SYSTEMS

14 15

• 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 Project Execution

• 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

Smart Facilities

• 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.

Smart Installation Smart Qualification

• 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 )

16 17

• 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.• We ensure your project is managed within budget, on time and meets your exact deliverables.

Smart Project Execution

• 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 customer prior to FAT visit

Smart Facilities

• 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.

Smart Installation Smart Qualification

• 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 to the customer to start Performance Qualification activities (PQ)

16 17

X - MODEL

ENGINEERING & AUTOMATION VALIDATION

V - MODEL


Top Down

ValidationReport

User RequirementsSpecification Validtion Plan

System Acceptance(Support only)

HW ConstructionHW Purchase

SW Implementation

Functional Specification Sequences/ Recipes

Quality Plan

HW Component AcceptanceSW Module Testing

(IQ Protocol and Report)

HW Design SpecificationSW (Module) Design Specification

PLC/ OPC/ PCS/ Feldbus/ SCADA/ LAN

HW Integration TestSW Integration Test

(OQ Protocol and Report)

Bottom Up

PQ

OQ

IQ

INSTALLATION

SAT

FAT

PerformanceQualification (PQ)

(Support only)

FunctionalQualification (OQ)

Engineering, Specification,Pre-Installation at our factory

HW DesignSpecification

Installation Testing (IQ)

Functional Specification Functional Testing (OQ)

InstallationQualification (IQ)

User RequirementsSpecifications

Functional Specification


ON

SITE

FACT

ORY

1918

X - MODEL


V - MODEL


Top Down

ValidationReport

User RequirementsSpecification Validtion Plan

System Acceptance(Support only)

HW ConstructionHW Purchase

SW Implementation

Functional Specification Sequences/ Recipes

Quality Plan

HW Component AcceptanceSW Module Testing

(IQ Protocol and Report)

HW Design SpecificationSW (Module) Design Specification

PLC/ OPC/ PCS/ Feldbus/ SCADA/ LAN

HW Integration TestSW Integration Test

(OQ Protocol and Report)

Bottom Up

PQ

OQ

IQ

INSTALLATION

PerformanceQualification (PQ)

(Support only)

FunctionalQualification (OQ)

Engineering, Specification,Pre-Installation at our factory


Installation Testing (IQ)

Functional Specification Functional Testing (OQ)

InstallationQualification (IQ)

User RequirementsSpecifications

Functional Specification


ON

SITE

FACT

ORY

SAT

FAT

18 19

CH

AN

GES

VIA

CA

D O

NLY

THIS DRAWING IS THE COPY RIGHT OF D.D.ENTERPRISES. ANY REPRODUCTION INPART OR WHOLE WITHOUT THE WRITTEN PERMISSION OF DDE IS PROHIBITED.

8

A

DRG NO :- 044B16-SUT-01-02-L001 REV :- 02

REV. DATE CHANGES DRAWN CHECKED APPROVED

SCALE : - NTS QTY. :-

TITLE :-

PROJECT NO. :-

7654321

87654321

B

C

D

E

F

A

B

C

D

E

F

00 PLW AC SD19.07.2017 ISSUED FOR CLIENT'S APPROVAL

044B16

01

D. D. ENTERPRISESDDE PLOT NO. 81-B/12 M.I.D.C. BHOSARI, PUNE,

MAHARASHTRA, INDIA-411026.

SYSTEM ARCHITECTURE FOR SUITE-1 (AQUEOUS) &SUITE-2 (SUSPENSION)

01 SMK AC SD24.11.2017 REVISED AS PER CLIENT'S COMMENT02 SK AC SD25.04.2018 NOTE 2 UPDATED

REFERENCE DRAWINGS

1) P&ID DRG NO :- 044B16-SUT-01-101-001 REV.asb2) P&ID DRG NO :- 044B16-SUT-02-101-001 REV.asb

NOTE

1) COMMUNICATION CABLE MARKED AS IS IN CUSTOMER SCOPE.2) 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.

SHEET :- 1 OF 5

1756-PA75 1756-PA75

REDUNDANT PLC SYSTEM (COMMON FOR ALL SUITES)

5PORT

1756

-L74

1756

-EN

2T

1756

-RM

2

1756

-N2

1756

-L74

1756

-EN

2T

1756

-RM

2

1756

-N2

1756

-EN

2T

1756

-N2

1756

-N2

1756

-N2

1756

-N2

1756

-EN

2T

OS

FT VIEW SE STATION250 DISPLAY

OS

REDUNDANT SCADA STATION (COMMON FOR ALL SUITES)


1734

IE4C

1734

AEN

T

1734

OE4

C

HUBER SYSTEM(SUITE-1 & 2)

1734

IE8C

1734

AEN

T

1734

OB

4

1734

IB8

CIP AREA(SUITE-1)

1734

IB4

AB

HMI10.4" HMI

Powerflex525

VFD

8PORT

VALVEGANG

-1

VALVEGANG

-2

1734

IE4C

1734

AEN

T

1734

OB

417

34 IB

4

MFG. AREA (SUITE-1)

AB

HMI10.4" HMI

Powerflex525

VFD

8PORT

VALVEGANG

-1

1734

IE8C

1734

AEN

T

1734

IB4

MFG. AREA(SUITE-1)

8PORT

VALVEGANG

-1

VALVEGANG

-2

1734

IE4C

1734

AEN

T

1734

OB

4

MFG. AREA (SUITE-1)

8PORT

VALVEGANG

-1

1734

IB4

AB

HMI10.4" HMI

Powerflex525

VFD

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE8C

1734

AEN

T

1734

OB

4

MFG. AREA(SUITE-1)

16PORTVALVE

GANG-1

1734

IB8LOAD

CELL

LOADCELL

LOADCELL

VALVEGANG

-2

VALVEGANG

-3

1734

IE8C

AB

HMI10.4" HMI

1734

IE8C

1734

AEN

T

1734

OB

4

FLT. AREA(SUITE-1)

16PORT

1734

IB8

1734

IE8C

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE4C

1734

AEN

T

1734

OB

4

8PORT

1734

IB4

LOADCELL

VALVEGANG

-1

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE4C

1734

AEN

T

1734

OB

4

8PORT

1734

IE2C

LOADCELL

VALVEGANG

-1

1734

VH

SC24

1734

VH

SC24

1734

VH

SC24

1734

VH

SC24

1734

VH

SC24

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE4C

1734

AEN

T

1734

OB

4

8PORT

1734

IB4

LOADCELL

VALVEGANG

-1

AB

HMI10.4" HMI

1734

IE8C

1734

AEN

T

1734

OB

417

34 IB

8

LOADCELL

VALVEGANG

-1

1734

IE4C

1734

VH

SC24

VALVEGANG

-2

1734

IE4C

1734

AEN

T

5PORT

500L-CIP SYSTEM (500L-CIP1-S1/S2 ) (CIP1)

400L JACKETED MANUFACTURING VESSEL(400L-JMV3-S1/S2) (V2)

400L JACKETEDMANUFACTURING VESSEL

(400L-JMV4-S1) (V3)


(1500L-JMV7-S1) (V5)1500L JACKETED FILTRATION VESSEL

(1500L-JFV1-S1) (V6)


(200L-JMV1-S1) (V7)


(400L-JMV2-S1/S2) (V4)


(20L-JMV5-S1) (V8)

750L JACKETED MANUFACTURING VESSEL

(750L-JMV6-S1) (V1)

RIO PANEL-01

SYSTEMARCHITECTURE

TO SUITE-2

Powerflex525

VFDPowerflex525

VFD

Powerflex525

VFD

Powerflex525

VFDPowerflex525

VFDPowerflex525

VFD

Powerflex525

VFD

GATEWAYPLX32-EIP

-MBTCPI/O'S FOR HARDWIRE

CONNECTION WITH HUBER SYSTEM

1783-BMS20CGLGIGABIT

DATABASE SERVER(ASSET CENTER ANDFACTORY TALKTRANSACTIONMANAGER5000 TAGS)

1756

-EN

2T

1756

-EN

2T

1756

-L74

1756

-EN

2T

1756

-EN

2T

1756

-L74

1756-RMC1-CABLE

TO SUITE-3TO SUITE-4

1734

IE2C


UTILITY STATION-01(044B16-U1-S1) (U1)

VALVEGANG

-1

1734

OB

4

MV7PP-01FV1PP-01

(COMMON FOR ALL SUITES)

VALVEGANG

-1

LOADCELL

VALVEGANG

-2

VALVEGANG

-3

Powerflex525

VFDPowerflex525

VFDPowerflex525

VFDPowerflex525

VFD

MFG. AREA(SUITE-1)

MFG. AREA (SUITE-1)

MFG. AREA(SUITE-1)

MFG. AREA(SUITE-1)

1734

IE2C

1734

IE2C

1734

IB4

1734

IE2C

1734

IE2C

Powerflex525

VFDPowerflex525

VFDPowerflex525

VFD

16PORT

COMMON PANEL FOR VFD (SUITE-1)

(SERVICE AREA)

Powerflex525

VFD

1734

IE2C

• 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

SMART AUTOMATION

• Reliable and seamless integration into existing control strategies & erternal SCADA/ MES

• Batching systems with eBMR recipe management

• Graphics based process automation with loops

• DDE offers 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.)

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 (ISA S99)• Fieldbuses (IEC 61158)

20 21

• 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

SMART AUTOMATION

• 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.)

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 (ISA S99)• Fieldbuses (IEC 61158)

06 21

CH

AN

GES

VIA

CA

D O

NLY

THIS DRAWING IS THE COPY RIGHT OF D.D.ENTERPRISES. ANY REPRODUCTION INPART OR WHOLE WITHOUT THE WRITTEN PERMISSION OF DDE IS PROHIBITED.

8

A

DRG NO :- 044B16-SUT-01-02-L001 REV :- 02

REV. DATE CHANGES DRAWN CHECKED APPROVED

SCALE : - NTS QTY. :-

TITLE :-

PROJECT NO. :-

7654321

87654321

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C

D

E

F

A

B

C

D

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F

00 PLW AC SD19.07.2017 ISSUED FOR CLIENT'S APPROVAL

044B16

01

D. D. ENTERPRISESDDE PLOT NO. 81-B/12 M.I.D.C. BHOSARI, PUNE,

MAHARASHTRA, INDIA-411026.

SYSTEM ARCHITECTURE FOR SUITE-1 (AQUEOUS) &SUITE-2 (SUSPENSION)

01 SMK AC SD24.11.2017 REVISED AS PER CLIENT'S COMMENT02 SK AC SD25.04.2018 NOTE 2 UPDATED

REFERENCE DRAWINGS

1) P&ID DRG NO :- 044B16-SUT-01-101-001 REV.asb2) P&ID DRG NO :- 044B16-SUT-02-101-001 REV.asb

NOTE

1) COMMUNICATION CABLE MARKED AS IS IN CUSTOMER SCOPE.2) 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.

SHEET :- 1 OF 5

1756-PA75 1756-PA75

REDUNDANT PLC SYSTEM (COMMON FOR ALL SUITES)

5PORT

1756

-L74

1756

-EN

2T

1756

-RM

2

1756

-N2

1756

-L74

1756

-EN

2T

1756

-RM

2

1756

-N2

1756

-EN

2T

1756

-N2

1756

-N2

1756

-N2

1756

-N2

1756

-EN

2T

OS


OS

REDUNDANT SCADA STATION (COMMON FOR ALL SUITES)


1734

IE4C

1734

AEN

T

1734

OE4

C


1734

IE8C

1734

AEN

T

1734

OB

4

1734

IB8

CIP AREA(SUITE-1)

1734

IB4

AB

HMI10.4" HMI

Powerflex525

VFD

8PORT

VALVEGANG

-1

VALVEGANG

-2

1734

IE4C

1734

AEN

T

1734

OB

417

34 IB

4

MFG. AREA (SUITE-1)

AB

HMI10.4" HMI

Powerflex525

VFD

8PORT

VALVEGANG

-1

1734

IE8C

1734

AEN

T

1734

IB4

MFG. AREA(SUITE-1)

8PORT

VALVEGANG

-1

VALVEGANG

-2

1734

IE4C

1734

AEN

T

1734

OB

4

MFG. AREA (SUITE-1)

8PORT

VALVEGANG

-1

1734

IB4

AB

HMI10.4" HMI

Powerflex525

VFD

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE8C

1734

AEN

T

1734

OB

4

MFG. AREA(SUITE-1)

16PORTVALVE

GANG-1

1734

IB8LOAD

CELL

LOADCELL

LOADCELL

VALVEGANG

-2

VALVEGANG

-3

1734

IE8C

AB

HMI10.4" HMI

1734

IE8C

1734

AEN

T

1734

OB

4

FLT. AREA(SUITE-1)

16PORT

1734

IB8

1734

IE8C

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE4C

1734

AEN

T

1734

OB

4

8PORT

1734

IB4

LOADCELL

VALVEGANG

-1

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE4C

1734

AEN

T

1734

OB

4

8PORT

1734

IE2C

LOADCELL

VALVEGANG

-1

1734

VH

SC24

1734

VH

SC24

1734

VH

SC24

1734

VH

SC24

1734

VH

SC24

AB

HMI10.4" HMI

Powerflex525

VFD

1734

IE4C

1734

AEN

T

1734

OB

4

8PORT

1734

IB4

LOADCELL

VALVEGANG

-1

AB

HMI10.4" HMI

1734

IE8C

1734

AEN

T

1734

OB

417

34 IB

8

LOADCELL

VALVEGANG

-1

1734

IE4C

1734

VH

SC24

VALVEGANG

-2

1734

IE4C

1734

AEN

T

5PORT

500L-CIP SYSTEM (500L-CIP1-S1/S2 ) (CIP1)

400L JACKETED MANUFACTURING VESSEL(400L-JMV3-S1/S2) (V2)


(400L-JMV4-S1) (V3)


(1500L-JMV7-S1) (V5)1500L JACKETED FILTRATION VESSEL

(1500L-JFV1-S1) (V6)


(200L-JMV1-S1) (V7)


(400L-JMV2-S1/S2) (V4)


(20L-JMV5-S1) (V8)

750L JACKETED MANUFACTURING VESSEL

(750L-JMV6-S1) (V1)

RIO PANEL-01

SYSTEMARCHITECTURE

TO SUITE-2

Powerflex525

VFDPowerflex525

VFD

Powerflex525

VFD

Powerflex525

VFDPowerflex525

VFDPowerflex525

VFD

Powerflex525

VFD

GATEWAYPLX32-EIP

-MBTCPI/O'S FOR HARDWIRE

CONNECTION WITH HUBER SYSTEM

1783-BMS20CGLGIGABIT

DATABASE SERVER(ASSET CENTER ANDFACTORY TALKTRANSACTIONMANAGER5000 TAGS)

1756

-EN

2T

1756

-EN

2T

1756

-L74

1756

-EN

2T

1756

-EN

2T

1756

-L74

1756-RMC1-CABLE

TO SUITE-3TO SUITE-4

1734

IE2C


UTILITY STATION-01(044B16-U1-S1) (U1)

VALVEGANG

-1

1734

OB

4

MV7PP-01FV1PP-01

(COMMON FOR ALL SUITES)

VALVEGANG

-1

LOADCELL

VALVEGANG

-2

VALVEGANG

-3

Powerflex525

VFDPowerflex525

VFDPowerflex525

VFDPowerflex525

VFD

MFG. AREA(SUITE-1)

MFG. AREA (SUITE-1)

MFG. AREA(SUITE-1)

MFG. AREA(SUITE-1)

1734

IE2C

1734

IE2C

1734

IB4

1734

IE2C

1734

IE2C

Powerflex525

VFDPowerflex525

VFDPowerflex525

VFD

16PORT

COMMON PANEL FOR VFD (SUITE-1)

(SERVICE AREA)

Powerflex525

VFD

1734

IE2C

• 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 Integration Services

SMARTER SOLUTIONS

• 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

Smart After Sales and Service Support

22 23

• 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

Smart Integration Services

SMARTER SOLUTIONS

• 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• Onsite and Online services

Smart After Sales and Service Support

06 23

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.

BUILDING RELATIONSHIPSWORLDWIDE

24

Factory Address:81- B/12, M.I.D.C. Bhosari,Pune - 411 026, Maharashtra, IndiaPh: +91 (20) 2712 1631 / 7189 | +91 (20) 6611 3189 / 90

Branch Office: Hyderabad | New Jersey www.ddentp.com | [email protected]

Head Office:S- 76/1, M.I.D.C. Bhosari,Pune - 411 026, Maharashtra, IndiaPh: +91 (20) 2712 2514 / 5 / 6 / 7

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