DDE Smarter Solutions Brochure - PPT

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Smarter Solutions for Enduring Value
Design Manufacture Commission Qualify
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ABOUT US
THE WAY FORWARD We are rede?ning boundaries in
the high purity business while working with
sterile formulations, bio-pharmaceuticals,
vaccines and MDI industries.
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
industrys toughest problems.
We have positioned ourselves to be the worlds
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 diversi?ed as the
industry in which we operate.
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Process Engineering
Automation
Quali?cation Validation
Plan
Design Engineering
Training
After-Sales Support
Manufacturing
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 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-e?ective and in compliance with prevalent
regulatory requirements. We partner throughout
the project life cycle Our advanced
manufacturing processes involve the industrys
best in class techniques and knowledge accrued
over the years.
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.
At DDE, we dont just execute a project, we
ensure highest quality and consistency to
deliver smarter solutions for enduring value.
We understand that creating solutions for any
industrys toughest challenges not only requires
current wisdom to be harnessed but also
investment in smarter future-proof technologies
and processes.
We partner with you for installing and
validating systems to ensure a quick
quali?cation for minimized time to market.
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 e?ciently
and e?ectively.
To o?er these life saving equipments, we follow
all engineering and quality standards. This can
be seen through our long-standing association
with the worlds best and biggest pharmaceutical
companies.
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.
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SMARTER INDUSTRIES

• Bio-pharma
• Cell Culture / Microbial / Bio-Enzymes

• Sterile Formulations
• 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 Dosage Inhaler)
• Dry powdered inhaler, Pressurized metered dose
  inhalers, Nebulizers

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SMARTER SOLUTIONS

• Sterile Formulations
• Sterile formulations manufacturers are looking
  for strong and e?ective 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
• Bu?er Vessels for all ?lling 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.

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SMARTER SOLUTIONS

• Bio-pharma Vaccines
• Bio-pharma and vaccine industries require large
  investment in time and capital to e?ectively
  translate scienti?c discovery into novel and
  a?ordable therapies.
• With decades of experience, DDE has become a
  strategic driver in providing scalable and
  ?exible bioprocess solutions of high quality.
• Smarter Systems
• In-Situ Fermenters/ Bioreactors
• Upstream bioprocess vessels for Media /Bu?er
  preparation, Feed hold, Serum Vessels
• Transfer sterile ?ltration skids with Integrity
  testing
• Downstream processing Harvest Vessels, Pooling
  Vessels, Bu?er preparation, Puri?cation Vessels
• TFF/ Cross ?ow concentration Skids
• Blending/ Formulations vessels
• Product feed vessels for ?lling machine
• Integrated suites
• Virus inactivation systems
• Bio-kill/ Decontamination systems - Continuous
  Batch
• CIP systems Mobile/ Centralized
• SIP systems Integrated/ Standalone
• Temperature control units (TCUs)

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SMARTER SOLUTIONS

• MDI / DPI
• There has been a signi?cant 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

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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 o?er consistent
quality, we use high precision components
integrated with a fully automated and
intelligent control system and a full cGMP
documentation package.

• 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

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SMARTER SYSTEMS
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• Smart Project Execution
• 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 Quali?cation
• We use a quali?cation documentation system to
  monitor commissioning tests (FAT-SAT), optimize
  non-conformity management, facilitate and speed
  up reporting processes (review work?ow,
  protocol approval, reports), standardize test
  protocols
• Quali?cation is usually carried out by
  conducting the following activities,
  individually or combined
• Design Quali?cation (DQ)
• The tests and veri?cation required to be
  undertaken during commissioning is
• documented in Equipment Quali?cation Plan
  (EQP), which is approved by the end user prior
  to initiation of IQ OQ activities.
• Installation Quali?cation (IQ) Documented
  veri?cation that the equipment or systems are
  installed or modi?ed
• Operational Quali?cation (OQ) Documented
  veri?cation 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 speci?ed in the SOP the IQ/OQ
  protocol is completed)
• Performance Quali?cation (PQ) Experienced
  Commissioning and Performance Quali?cation (PQ)
  team has the required technical skills and
  quali?cation experience for successful handing
  over
• to the customer to start Performance
  Quali?cation activities (PQ)

• Smart Installation
• 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 ?eld installation
  work.
• Our engineers also partner with the customers
  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 stakeholders
  expectations.

• 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
  customers site
• All skids are fully tested and quali?ed
• All pre-FAT reports are available for customers
  prior to FAT visit

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V - MODEL
X - MODEL
ENGINEERING AUTOMATION VALIDATION
ENGINEERING AUTOMATION VALIDATION
Performance Quali?cation (PQ) (Support only)
User Requirements Speci?cations
User Requirements Speci?cation Validtion Plan
System Acceptance (Support only)
PQ
Functional Quali?cation (OQ)
Functional Speci?cation
ONSITE
Validation Report
Quality Plan
SAT
Installation Quali?cation (IQ)
HW Design Speci?cation
Functional Speci?cation Sequences/ Recipes
HW Integration Test SW Integration Test (OQ
Protocol and Report)
OQ
INSTALLATION
Functional Testing (OQ)
Functional Speci?cation
HW Component Acceptance SW Module Testing (IQ
Protocol and Report)
HW Design Speci?cation SW (Module) Design
Speci?cation PLC/ OPC/ PCS/ Feldbus/ SCADA/ LAN
FAT
FACTORY
IQ
HW Design Speci?cation
Installation Testing (IQ)
HW Construction HW Purchase SW Implementation
Top Down
Bottom Up
Engineering, Speci?cation, Pre-Installation at
our factory
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SMART AUTOMATION
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1 2 THIS DRAWING IS THE COPY RIGHT OF
D.D.ENTERPRISES. ANY REPRODUCTION IN PART OR
WHOLE WITHOUT THE WRITTEN PERMISSION OF DDE IS
PROHIBITED.
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SYSTEM
ARCHITECTURE
REDUNDANT SCADA STATION (COMMON FOR ALL SUITES)
REDUNDANT PLC SYSTEM (COMMON FOR ALL SUITES)
A
A
FT VIEW SE STATION 250 DISPLAY
FT VIEW SE STATION 250 DISPLAY
DATABASE SERVER (ASSET CENTER AND FACTORY TALK
TRANSACTION MANAGER 5000 TAGS)
1756-EN2T
1756-RM2
1756-EN2T
1756-RM2
1756-EN2T
1756-EN2T
1756-EN2T
1756-EN2T
1756-EN2T
1756-EN2T
1756-L74
1756-N2
1756-L74
1756-N2
1756-N2
1756-N2
1756-L74
1756-L74
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 category
  softwares
• Real time data input for MES systems, Alarm
  event noti?cation
• Fully user con?gurable and upgradeable, Scalable
  software, Unique customization level and ?exible
  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
• Quali?cation 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
(COMMON FOR ALL SUITES)
HUBER SYSTEM (SUITE-1 2)
GATEWAY PLX32-EIP -MBTCP
I/O'S FOR HARDWIRE
HUBER SYSTEM (SUITE-3 4)
CONNECTION WITH HUBER SYSTEM 5
B
B
P O R T
1783-BMS20CGL GIGABIT
1734 AENT
1734 IE4C 1734 OE4C
MFG. AREA (SUITE-1)
MFG. AREA
MFG. AREA (SUITE-1)
MFG. AREA (SUITE-1)
(SUITE-1)
CIP AREA(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
VALVE
8
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 (ISA S99)
• Fieldbuses (IEC 61158)

8 P O R T
VALVE GANG -2
C
LOAD CELL
C
1734 AENT
1734 IE4C 1734 IE2C
1734 AENT
1734 IE4C 1734 IE2C 1734 IB4 1734 OB4 1734 VHSC24
1734 IE4C 1734 IE2C 1734 IB4 1734 OB4 1734 VHSC24
1734 AENT
1734 AENT
1734 IE4C 1734 IB4 1734 OB4
1734 AENT
1734 IE8C 1734 IE2C 1734 IB8 1734 IB4 1734 OB4
VALVE GANG -1 RIO PANEL-01

1734 IE8C 1734 IB4 1734 OB4
1734 AENT
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
Powerflex525

VFD VFD Powerflex525 Powerflex525
10.4" HMI
400L JACKETED MANUFACTURING VESSEL
(400L-JMV2-S1/S2) (V4)
200L JACKETED 10.4" HMI MANUFACTURING
VESSEL (200L-JMV1-S1) (V7)
20L JACKETED
UTILITY STATION-01 (044B16-U1-S1) (U1)
MANUFACTURING VESSEL 10.4" HMI (20L-JMV5-S1) (V8)
500L-CIP SYSTEM (500L-CIP1-S1/S2 ) (CIP1)
(SERVICE AREA)
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 VALVE LOAD
LOAD VALVE
16 P O R T
VFD VFD VFD VFD Powerflex525
Powerflex525
Powerflex525
Powerflex525
VALVE
GANG GANG CELL -2 -3
16 CELL GANG
P O R T
-2
GANG VALVE
1734 IE8C 1734 IE4C 1734 IB8 1734 OB4 1734 VHSC24
-1
LOAD CELL
1734 AENT
1734 AENT
GANG -2
1734 IE8C 1734 IE8C 1734 IE2C 1734 IB8 1734
OB4 1734 VHSC24
1734 IE4C 1734 IE2C 1734 IB4 1734 OB4 1734 VHSC24
16 P O R T
1734 AENT
1734 AENT
VALVE
1734 AENT
1734 IE8C 1734 IE8C 1734 IB8 1734 OB4 1734 VHSC24
VALVE
1734 IE4C 1734 IE2C 1734 IB4 1734 OB4
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
E

VFD
E
Powerflex525
10.4" HMI
10.4" HMI
10.4" HMI 400L JACKETED
1500L JACKETED
750L JACKETED MANUFACTURING VESSEL
VFD Powerflex525
VFD VFD VFD VFD VFD VFD
400L JACKETED MANUFACTURING VESSEL
(400L-JMV3-S1/S2) (V2)
VFD
MANUFACTURING VESSEL
MANUFACTURING VESSEL 1500L JACKETED FILTRATION
VESSEL (400L-JMV4-S1) (V3) (1500L-JFV1-S1) (V6)
Powerflex525
Powerflex525 Powerflex525 Powerflex525
Powerflex525 Powerflex525 Powerflex525
(1500L-JMV7-S1) (V5)
FV1PP-01
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
AC
SD
AC
SD
SD
00 19.07.2017 ISSUED FOR CLIENT'S APPROVAL PLW AC
CHANGES VIA CAD ONLY
REV. DATE CHANGES DRAWN CHECKED APPROVED
1) PID DRG NO - 044B16-SUT-01-101-001
REV.asb 1) COMMUNICATION CABLE
MARKED AS IS IN CUSTOMER SCOPE.
D. D. ENTERPRISES PLOT NO. 81-B/12 M.I.D.C.
BHOSARI, PUNE, MAHARASHTRA, INDIA-411026.
PROJECT NO. -
2) PID 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
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.
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
4
3
2
1
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SMARTER SOLUTIONS

• Smart Integration Services
• Integration of di?erent 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 OEMs
  Process systems
• Handshaking with Controllers of OEMs process
  systems
• Control system audits
• Some of the process system OEMs integrated by us
  include

• Smart After Sales and Service Support
• Quick telephonic support
• Safe remote access in compliance with 21 CFR
  part 11
• Maintenance contract for reliable and cost
  e?ective plant planning
• Pre-arranged maintenance visits ensuring Zero
  downtime
• Recommended spares
• Emergency spares replacement
• Software upgradation
• Process and instrumentation support
• System modi?cations, extensions, improvements
• Onsite and Online services

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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 companys worldwide expansion and
look forward to strengthen and build
relationships for a smarter future. Together we
can achieve growth and pro?tability.
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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_at_ddentp.com
Head O?ce S- 76/1, M.I.D.C. Bhosari, Pune - 411
026, Maharashtra, India Ph 91 (20) 2712 2514 /
5 / 6 / 7
Branch O?ce Hyderabad New Jersey