SPECTRUM PHARMATECH CONSULTANTS - NEW COMPANY PROFILE

20
CELEBRATING
Company Profile
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Contents
About Us 1
Field of Expertise 4
Our Capabilities 5
Our Clients 7
Case Studies 11
Project Coverage 13

ABOUT US
SPECTRUM PharmaTECH Consultants Pvt. Ltd. (SPECTRUM) is a
knowledge based, fully integrated Architectural and Engineering firm
providing state of art solutions to clients in the pharmaceutical, biotech,
food, beverage and cosmetic industries worldwide, satisfying the strictest
regulatory requirements.
Started in 1995, SPECTRUM has been offering one-stop Engineering
Solutions to APIs, Finished Dosage Forms (OSD, Semi Solids, and Aseptic
Products.), Analytical and Microbiological Laboratories, Pilot Plants, R&D
Centres, High Potent Products, Herbal Medicines, Cosmetics etc.
.
VISION:
To be a leading Architectural and Engineering Consultant
providing integrated services from Laboratory to Consumer.
To achieve our vision we will strive to:
Provide reliable professional services to our clients
Forge mutually beneficial and lasting relationships with our clients and
partners
Develop our staff to deliver the highest quality of service and to seek
innovative and creative approaches to problem solving.
1
SPECTRUM employs more than 80 technical professionals and offers a
broad range of highly experienced and motivated engineers with hands on
experience and technical expertise in their chosen domains.
With a strong history of innovation and technological advancement, our
experts seek out not only the most up to date equipment but also the most
logical solutions for our clients.
SPECTRUM's designs are based on foresight and experience, resulting in GMP
compliance by design.

Advantage SPECTRUM
SPECTRUM has a track record of working with leading Indian and Multinational clients. One can count on SPECTRUM
to deliver quality advice based on a thorough market research, current trends and future scenario; the best and most
practical designs; track schedules and monitor construction to produce the most suitable, cost effective solutions within
fixed time-lines.
Single Source Reliability
You can count on SPECTRUM to deliver quality designs, track schedules &
monitor construction as an agent on your behalf.
Single source responsibility means the firm will fix a problem when it shows
up. Spectrum provides Single Point Reliability, which means that we will
avoid having most of those problems in the first place.
ETHICS:
SPECTRUM lays great emphasis on ethics and honesty. What
you get is a fair, unbiased and objective appraisal of the
market.
Commitment
SPECTRUM is committed to providing their clients with the highest possible level of architectural, planning, design,
engineering and validation services.
Our Quality policy
Ensuring customer satisfaction through leadership in engineering, technology and management services.
Spectrum is committed to understand, meet and when possible exceed our Customer's expectations through continuous
improvement of our working methods, systems and processes. We are dedicated to delivering defect-free services to all
our customers on time - every time.
Passion for excellence, obsession with customer satisfaction, integrity in our commitments and mutual respect in our day to
day working guide us to fulfilling this.
2

Sustainability
SPECTRUM gives prime importance to energy efficient designs and undertakes strict measures to protect the
environment. All our designs by policy are zero discharge facilities (unless specifically requested otherwise) that use all
the waste water generated on site for internal usage.
We take design decisions that help in consumption of optimum energy required only and no more.
We also recognize that land is the most valuable asset today. We ensure during the conceptualization stage itself that we
optimize its usage and always strive for ability to expand in future.
Our Approach
At SPECTRUM we have embraced the Project Cycle
Approach. We participate and guide the Client through
the project life cycle from concept design, basic and
detailed engineering, undertake project management
along with construction supervision to validation and
start-up of the facility.
We believe that as consultants we are but an extension
of our clients. Each of our project team members not
only aim but achieve client satisfaction.
Hand
Over
Commissioning
&
Qualification
Construction
Procurement Assistance
Basic & Detailed Engineering Design
Concept Design and Master Planning
You & We
WE HELP YOU TO CONVERT
YOUR PLANS FOR TODAY INTO
A BETTER
TOMORROW
We recognize that our team is not the largest
that you will come across, but we also know
that you will be hard pressed to find a team
more agile, responsive and flexible enough to
accommodate your needs. We are engaged,
c o m m u n i c a t i v e , c o l l a b o r a t i v e a n d
committed.
After all we are an extension of you.
3

Field Of Expertise
INDUSTRIES
SERVED
We provide complete project
engineering services from concept
to commissioning with in-house
expertise for architectural, civil,
structural, mechanical, HVAC,
piping, water treatment, electrical,
effluent treatment and fire and
safety systems.
We Follow
®
Baseline Engineering guides published by ISPE
ISO 14644 – Design of Clean Room & Associated
Controlled Environments
US FDA
UK MHRA
SOUTH AFRICAN MCC
AUSTRALIAN TGA
INDIAN SCHEDULE – M
BRAZILIAN ANVISA
WHO GMP
DESIGN
APPROACH
FlexibleandComprehensive
EnvironmentProtection
SafetybyDesign
CostEffectiveSolutions
CustomizedEngineering
UnderstandtheClient’sRequirements
4

Our Capabilities
We provide complete project engineering services from concept to commissioning with in-house expertise for
architectural, civil, structural, mechanical, HVAC, piping and electrical engineering services. We are known in the
Pharmaceutical Industry for the services we undertake including:
Advisory/
Master Planning
Basis of
Design
Development
Engineering
Construction
Qualification
&
Validation
Pre-feasibility &
Feasibility studies
Master Planning &
Conceptual design
Site selection studies
Tenant Search
Benchmarking
EU-GMP / FDA
consulting
Due Diligence &
Audits
General Planning or
Engineering
Technology
Research
Equipment Study &
Procurement
Design Development
Civil & Architecture
Expansion/Relocatio
n/ Integration
Planning
Detailed Building
Engineering including
Architectural
Civil
Structural
Process
HVAC
Electrical
Mechanical & Piping
Utilities
Plumbing
Instrumentation &
Automation
Fire & Safety
Environmental
Inter - Disciplinary
Construction and
Project
Management
Site management
Construction
Supervision
Procurement
Time Cost
Estimation
Bill Certification
DQ / IQ / OQ
GMP Risk analysis
Computer system
validation
Cleaning validation
Support services for
process validation
Validation
Documentation
From the very level of conceptualizing, SPECTRUM participates with and guides the Client through the project life cycle
including assessment of project feasibility, master planning, architectural design, detailed engineering, risk and hazard
assessment, construction management to validation and start up.
We have a track of earning projects repetitively from world renowned national and international manufacturers like
Glenmark, Dr. Reddy's, Johnson & Johnson, RPG Life Sciences, Sanzyme, OmniActive, Novartis etc. This is a testimony
to the quality of service provided by us.
5

End To End Solutions for Your Business
SPECTRUM along with their
associates offers its clients endto-end
healthcare business
solutions enabling you to surpass
the short term as well as long term
goals.
Turnkey
setting up
State-of-the-art
cGMP compliant
facilities to
manufacture the
selected
products.
Technology
Identify
partners for
sourcing of
Techonology,
APIs, Intermediates,
Packaging material
and Finished
Products.
Product Portfolio
building by
identifying right
products with focus
on growing therapy
segments and
molecules.
End To End
Solutions
Recruitment
Support
recruitment of
personnel for
Operations.
Market Potential
Study for
Domestic Sale &
Exports.
Weareproudofourability
tocreateanddeliver
bettersolutionstoourclients
24
6

Key Clients: International
Acme, Bangladesh
Beximco Pharmaceu cals,
Bangladesh
Ethiopian Pharmaceu cal
Manufacturing (EPHARM), Ethiopia
Geltech, Dubai
Glenmark Pharmaceu cals, Brazil
Glenmark Generics, Argen na
Jizhong Pharma, China
Pharmasyntez, Russia
East Pharm, Russia
Kusum Pharm, Ukraine
Neapolis Laboratories, Tunisia
Letap Pharmaceu cals, Ghana
Medica Pharmaceu cals, Yemen
Novast Laboratories, China
Pharmax Pharmaceu cals, Dubai
Polygon FZC, Turkmenistan
Swiss Biogenics, Sri Lanka
Ultra Pharma, Bangladesh
A J Biologics, Malaysia
BDA Life Science, Congo
BIEM ILAC, Turkey
7

Key Clients: Finished Dosage Forms
Apex Laboratories
Aurobindo Pharma
AVN Ayurveda
Dr. Reddys Laboratories
Emmellen Biotech
Famycare
Glenmark Generics
Glenmark Pharmaceu cals
Helvoet Pharma
Hygieia Biogenics
Intas Pharmaceu cals
IPCA Labs
Korten Pharmaceu cals
Kusum Healthcare
M J Biopharm
Mepro Pharmaceu cals
MSN Laboratories
Naprod Life Sciences
Novar s Enterprises
Orchid Healthcare
Raichem Life Sciences (Shilpa
Medicare)
RPG Life Sciences
Sandoz
Sanzyme (Formerly known as
Unisankyo)
Shreya Life Sciences
Wincoat Colours & Coa ngs
8

Key Clients: Active Pharmaceutical Ingredients
Alkem Laboratories
Amrutanjan Healthcare
BASF Coa ng (India)
Dr. Reddy’s Labs
Embio
Enaltec Labs
Fermenta Biotech
Glenmark Generics
Mac-Chem
Navin Flourine Interna onal
Omni Ac ve Health Technologies
Reliance Life Sciences
RPG Life Sciences
Sterling Biotech
Unimark Remedies
Zydus Cadilla
9

Key Clients: Biopharmaceuticals
Biological E.
Fermenta Biotech
Kasiak Labs (Part of Bharat Serums
and Vaccines Group)
Sanzyme (Formerly known as
Unisankyo Ltd.)
Tex Biosciences
Key Clients: Labs, R&D and Pilot Plants
Wockhardt
Ivax India
Janssen Cilag
Lupin
Mankind Pharma
Merck India
Novar s Healthcare
Promed Research Centre
Sandoz
Watson India
10

Case Studies
Finished Dosage Forms
SOLID ORAL FACILITY
Glenmark Generics Ltd., Goa, India
This US FDA approved facility has a total built up area of 14800 Sq.m.
comprising of a utility block and main manufacturing block complete
with processing areas, quality control laboratory, warehouse,
personnel gowning areas and service areas for air handling units and
purified water generation and distribution system. This facility was
constructed in a phase-wise manner over a period of 24 months.
The facility has five lines for manufacture of Tablets. Each line
comprises of multiple suites for granulation, drying, blending,
compression, and coating. The facility has a central packing area with
provision for blister (Alu-PVC, Alu-Alu), and Bulk Packing.
The construction activities during the expansions were planned in such
a manner that at no time there was stoppage of production. Necessary
measures to minimize the interference with the ongoing operations
were adopted.
SCOPE OF SERVICES:
·Basic Engineering, Detail Engineering, Commissioning
& Start Up
SOLID ORAL & LIQUID ORAL FACILITY
Aurobindo Pharmaceuticals Ltd. , Hyderabad, India
This US FDA approved facility was built on a green-field site. The
facility comprises of two four-storey blocks built adjacent to each
other and interconnected through corridors on each floor.
The total constructed area of the production blocks is 26000 sq
meters inclusive of Warehouse and personnel gowning areas. The
facility was built in a time span of 18 months. The blocks have
manufacturing sections for three finished dosage forms viz. Tablets,
Dry Powder Suspensions and Liquid Syrup Suspensions.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance, Site Audits, Commissioning &
Start Up
The manufacturing section comprise of 7 Granulation suites, 8 Tablet
Compression suites, 7 Coating suites, 6 Packing lines, 1 line for Dry
Syrups and 1 line for Liquid Syrups. Facility designed as a multistorey
facility with intermediate flow of materials by gravity. This
allows effective utilization of ground space.
11

Case Studies
Finished Dosage Forms
SOLID ORALS & INJECTABLE FACILITY (ONCOLOGY)
Shilpa Medicare Ltd. (Raichem LifeSciences), Hyderabad, India
The facility is designed to meet the regulatory requirements of
international bodies such as US FDA, UK MHRA, Australian TGA,
Brazilian ANVISA, PMDA Japan. The entire development comprises of 7
separate blocks spread over 27000 Sq.M. of plot. The structures planned
include Oral Solids block, Injectable Block, R & D Block, Quality Control &
Quality Assurance Block, Administration Block, Canteen, Utility Block,
and other ancillaries like Security cabin, Pump rooms, ETP, etc.
SCOPE OF SERVICES:
Concept Design,
Basic Engineering,
Detailed Engineering,
Containment Strategies,
Procurement Assistance,
Construction Management
SOLID ORAL FACILITY (HORMONES)
Glenmark Generics Ltd., Goa, India
This US FDA approved facility was built on a green-field site and
comprised of two-storey production block along with other ancillary
blocks.
The production block has a pilot plant and a commercial scale
manufacturing section for hormones in Tablet Form. The total built up
area of the is 4830 sq meters which houses pilot plant, commercial
scale manufacturing section, packaging section, warehouse, personnel
gowning areas, technical area for AHUs and routing of services, Quality
control laboratories and administration offices.
The facility was built in a time frame of 10 months. The plant was
designed with a prime emphasis on product, personal & environmental
safety. Layout was prepared to allow unidirectional movement of
material and personnel and minimize potential mix-ups. The main
manufacturing areas were maintained at negative pressure with
respect to peripheral socially clean corridor.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance, Construction Management,
Commissioning & Start Up, Validation Support
12

PROJECT COVERAGE
GEORGIA
CONGO
MALAYSIA
INDONESIA
Note: The locations marked are only indicative

Case Studies
Finished Dosage Forms
PILOT PLANT (HI-POTENT PRODUCTS)
Janssen Cilag Pharmaceuticals, (Johnson & Johnson), Mumbai, India
This Pilot Scale Manufacturing facility for Solids, Liquids & Ointments was set up in a time span of 20 months.
The facility is designed for handling PBOEL 3B compounds. It is proposed to be one of J&J's prime facilities for handling high potent
formulations. Though the facility was a green field project, the constraint was that it was set up in an existing manufacturing site of
SCOPE OF SERVICES:
Concept Design
Basic Engineering
Detail Engineering
Procurement Assistance
Site Audits
Construction Management
Commissioning & Start Up
Validation Support
Janssen Cilag in Mumbai. This site is
located within a largely residential area of
Mumbai, and there were lots of restrictions
as far as usable ground space, height,
environmental protection etc. were
concerned.
The facility consists of the following main
sections Ware House, Development Lab,
Pre Formulation Scale Manufacturing, Pilot
Scale manufacturing. Approximate built up
area of the facility is 2000 Square Meters.
The facility is a Ground plus three-storied
structure.
LIQUID & FREEZE DRIED INJECTABLE FACILITY (ONCOLOGY)
Glenmark Generics Ltd., Pilar, Argentina
The facility was designed to produce Liquid and Freeze Dried Oncology
Injectables. The facility was designed on a green-field site of about
10000 Sq.M. The main block is designed as a two storey building with
Production area, Warehouse, Personnel Gowning areas housed on the
Ground Floor and the Quality Assurance and Quality Control sections
housed on the First Floor.
The Vial Filling line and Freeze Drier have been procured from leading
manufacturers in Europe. Clean room panels, HVAC items, Hi-Purity
water generation and distribution systems and other process
equipments have been supplied from India to reduce the project cost.
The AHUs have Bag-In Bag-Out type filter arrangement to avoid
exposure of operator to potent dust while replacing the filter. The
process effluents generated are first deactivated and then released into
the main effluent treatment plant. The exhaust air from various systems
is filtered thru ULPA filters prior to release in to the atmosphere.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance, Construction Management,
Commissioning & Start Up, Validation Support
14

Case Studies
Finished Dosage Forms
METERED DOSE INHALERS
Glenmark Pharmaceuticals Ltd., Baddi, India
The facility is designed to produce 'Metered Dose Inhalers' and
has a total built up area of about 3500 Sq.M. The main block is
designed as a three floor structure and houses Production
area, Stores, Personnel Gowning areas and a compact Quality
Control section.
The MDI Filling line has been procured from DH Industries
(Pamasol), UK. The line has an arrangement for single and
double stage propellant filling of containers. HFA 134a will
be used as propellant.
SPECTRUM was involved in developing Process P&IDs
including P&IDs for transfer of pressurized HFA, URS for
Process Vessels and in the process has gained valuable
exposure to special design requirements of such facilities. The
layout is planned in a manner so as to enable modular
expansion of the facility to accommodate second filling line in
future.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail
Engineering, Procurement Assistance, Construction
Management, Commissioning & Start Up.
INSULIN INJECTABLES, ORAL SOLIDS &
CEPHALOSPORINE POWDER INJECTABLE FACILITY
M J Biopharm, Navi Mumbai, India
SCOPE OF SERVICES:
Concept Design
Basic Engineering
Detail Engineering
Procurement Assistance
Validation Support
The facility was built with technical support of Eli-Lily, USA.
SPECTRUM's personnel visited US plant of Eli-Lily to understand
manufacturing operations prior to design of the facility.
The entire development comprises of 3 separate buildings spread
over 25000 Sq.M. of plot with the main block housing manufacturing
sections for Insulin Injectables. The Cephalosporine Dry Powder
Injectables are produced in a dedicated block and houses its own
manufacturing, warehousing and personnel gowning sections.
Built in a time span of 18 months, this Facility is approved by UK
MHRA, South African MCC, Brazil ANVISA.
15

Case Studies
Finished Dosage Forms
LARGE VOLUME PARENTERALS FACILITY
JSC Eastpharm, Vladivostok, Russia
The project involved setting up facility for producing Large
Volume Parenterals and associated testing laboratories at
Vladvostok in Russia. The facility was planned in accordance to
cGMP requirements of WHO.
SPECTRUM was involved in sizing and selection of process
Detail Engineering
equipment and SPECTRUM's scope included developing
Procurement Assistance
concept designs, basic engineering and detailed engineering.
Construction Management
Systems such as Modular Clean room panels, HVAC, Process
Validation Assistance
Equipment, Generation and Distribution systems for Purified
Water, WFI, Pure Steam were supplied from India.
Phase I of the project, has an annual installed capacity of 12 Million bottles of 500 ml fill volume whereas the Phase II of the project
augmented the annual capacity by additional 8 Million bottles of 100 ml fill volume.
16
SVP with BFS MACHINE, PENICILLIN & CEPHALOSPORIN DRY
POWDER INJECTABLES FACILITY and GENERAL ORAL SOLIDS FACILITY
SCOPE OF SERVICES:
Concept Design
Basic Engineering
Detail Engineering
Procurement Assistance
SCOPE OF SERVICES:
Concept Design
Basic Engineering
JSC Pharmasyntez, Irkutsk, Russia
The project involved setting up facilities for manufacturing SVP with BFS
machine for Water for Injection & Opthalmic products, General Oral
Solids, Penicillin Dry Powder Injectables and Cephalosporin Dry Powder
Injectables. The facilities were planned in an existing building and were
set up in accordance to cGMP requirements of WHO.
Unique feature of engineering was design of HVAC systems for sub-zero
temperatures of up to (– 40) deg.C. This required Humidification as the
humidity levels would fall to very low levels during winters. Systems such
as HVAC, Process Equipment, Generation and Distribution systems for
Purified Water, WFI, Pure Steam were supplied from India.
The project provided insight in to how project were executed in countries
of erstwhile Soviet Republic. It would typically involve preparing and
submitting project drawings and documents to a local project institute
who were the only ones authorized to design projects in Russia. The
institute would then translate all drawings in local language and then
issue the same to contractors for execution.
We have installed Rommelag 321 for manufacturing of ampoules for Water for Injection and ophthalmic products with BFS
technology. Machine has annual output 12.0 Million with one shift a day.

Case Studies
Finished Dosage Forms
INJECTABLE FACILITY (HORMONES)
SANZYME LTD, SHAMEERPET, HYDERABAD India
SCOPE OF SERVICES:
Concept Design
Basic Engineering
Detail Engineering
Procurement Assistance
Construction Management
Validation Support
The facility is designed to meet the regulatory
requirements of international bodies such as US FDA,
UK MHRA. The entire development comprises of 3
separate blocks spread over 15300 Sq.M. of plot. The
structures planned include Injectable Block, Bio Lab,
Utility Block, and other ancillaries like Security cabin,
Pump rooms, ETP, etc.
The salient design features of the facility include:
Combi line (Vial and Ampoule) for Hormonal Injections and with Lyophilization.
Dedicated Bio Animal Lab planned in the Plot
Construction of Process areas with Clean room Modular panels.
Clean Utility system consists of Purified water, Water for Injection and Pure steam planned for the Injectable plant.
Effluent deactivation prior to discharge to the main ETP.
SOLID ORALS & INJECTABLE FACILITY (ONCOLOGY)
Neapolis Pharma,Tunisia (Part of Medis Group)
The facility is designed to produce Oral Solids and Liquids
and Freeze Dried Injectables. The facility is designed in
accordance with regulatory requirements of EU GMP.
The salient design features of the facility include –
Isolators for Active Sampling & Dispensing, Solution
preparation for Injectables.
Single Pot Processor Technology for Granulation.
Contained transfer systems for Compression &
Coating machines.
Bag-in Bag-out filters for AHUs.
Pre-engineered concrete building.
Construction of Process areas with Clean room
panels.
Effluent deactivation system prior to discharge to the
main ETP.
SCOPE OF SERVICES:
Concept Design, Basic Engineering,
Detail Engineering, Procurement
Assistance, Commissioning
Assistance, Validation Support
17

Case Studies
Finished Dosage Forms
LAB and R&D FACILITY
Novartis Healthcare Pvt. Ltd., Thane, India
SPECTRUM designed and engineered a global research &
development laboratory & pilot scale manufacturing facility for
Novartis healthcare.
SCOPE OF SERVICES:
Project Management
The main sections built in the center were:
Basic Engineering
Analytical Laboratory
Detail Engineering
Wet Chemistry Lab
Procurement Assistance
Pilot Plant for OSD, Liquids & Semisolids.
Inspection & Expediting
Stability Chambers' section
Offices for Chemists
Construction Management
Utility Area
Validation Support
The Project was done in existing building. Approximate area of
he facility is 12,500 Square feet. Facility was planned to
accommodate 25 Chemists. All utilities such as Lab Gases & Air compressors were located on Terrace. The major constraint in the
project was that the Lab was located on 5th floor & all the utilities had to pass through the 6th floor to reach the Labs.This project was
completed in record time of 10 Months and was appreciated as a state of the art facility & was qualified by Novartis, Switzerland's
Quality Control Department
MULTIPLE DOSAGE FORMULATION FACILITY
Ethiopian Pharmaceuticals Ltd., Addis Ababa, Ethiopia
Ethiopian Pharmaceutical Manufacturing (EPHARM), fully owned by national government of Ethiopia, is the largest manufacturer
of Finished Dosage Formulations in Ethiopia. Epharm was planning to set up new manufacturing facilities in accordance with
cGMP requirements of WHO and had a requirement of carrying out Project Feasibility study before the initiative was taken further.
SCOPE OF SERVICES:
Capacity Planning, Conceptual Design, Basic Engineering ,
Project Costing, Project Implementation Strategy
18
SPECTRUM partnered with Industrial Project Services (IPS) of Ethiopia
to conduct this study. SPECTRUM's scope comprised of Capacity
Planning for all dosage forms based on Market Study reports and
Category of Products proposed by IPS. This was followed by sizing of
Production batches, recommending equipment capacities and preparing
facility layouts in accordance with GMP. The final capacities and facility
sizes were again reviewed based on the feasibility of accommodating
these blocks in the piece of land already available with Epharm.
The facilities or structures planned included Oral Solids Block for
General Products, Penicillin Block, Large Volume Parenteral Block, Oral
Liquids and Suspensions Block, Cephalosporin Block and Dermatology
formulation block. In addition to this a Central Warehouse,
Administration, Quality Control, Quality Assurance, R & D and Utility
Blocks were also planned. The total planned built up area was about
55,000 Sq. M.

Case Studies
Finished Dosage Forms
SCOPE OF SERVICES:
Project Management
Basic Engineering
Detail Engineering
Procurement Assistance
Inspection & Expediting
Construction Management
Validation Support
RUBBER COMPOUNDS PRODUCING FACILITY
Helvoet Pharma India Operation Pvt. Ltd., Near Pune, India
Helvoet Pharma, a Belgium based enterprise and part of the
Datwyler Group is one of the leading producers of Packaging
products for the Pharmaceutical industry in the world. This is
their first manufacturing plant in India.
The facility produces rubber components in the form of
Closures to be used in the Pharmaceutical industry. The facility
has sections for Rubber Mixing, Milling, Extrusion, Moulding,
Trimming, Washing and Packaging. Since the product being
produced was meant for use in pharmaceutical applications,
the environment in the washing sections of the facility were
classified and maintained in line with the cGMP standards
prevalent in the Pharmaceutical industry. The process water used in the final stages of washing of the components met the USP
standard of Purified Water and Water for Injection. In addition there were storage areas for Raw Materials, Packaging Material,
Finished products and Solvents, Quality Control laboratory, Administration offices, Maintenance areas, etc.
SOLID ORALS & INJECTABLE FACILITY (ONCOLOGY)
Naprod Life Sciences Pvt. Ltd., Tarapur, India
The facility comprised of a compact manufacturing block
with Dispensing and Manufacturing areas admeasuring
only 1000 Sq.M. The facility has received ANVISA
approval.
The production block has manufacturing sections for
Freeze-Dried Injectables and Oral Solids in the form of
Tablets and Capsules.
Dispensing of Actives and Solution Compounding for
Injectables is done inside Isolators. Personnel Protective
Gowns are planned for personnel working in other parts of
the manufacturing areas where they handle potent
material. The main manufacturing areas were maintained
at negative pressure with respect to peripheral socially
clean corridor. The process effluents generated are first
deactivated and then released into the main effluent
treatment plant.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Validation Support
19

Case Studies
Finished Dosage Forms
PHARMA CLUSTER
JSC Humanity, Tbilisi, Georgia
The ongoing facility is designed to meet the regulatory requirements of
international bodies such as EU GMP.
The entire development comprises of 9 separate blocks with total built up
area of 29000 Sq. Mtr. Facility has been planned in existing structures.
The structures planned include Repackaging for General products,
Repackaging for Oncology and Hormone products, Repackaging of
Cephalosporin products, Full manufacturing for Oral solid dosage form,
Central warehouse, Central Quality control laboratory, and
Administration & QA, Utility and HT yard. The projected cost of the entire
development is USD 30 Million.
The salient design features of the facility include:
Pre-Engineered Metal Building construction for the new buildings of
Full line Oral solid dosage form for faster construction.
Central warehouse is planned for storage of 10,000 pallets with selfsupported
ASRS.
Existing structures are refurbished to meet the GMP requirement.
Construction of Process areas with Clean room panels.
Effluent deactivation prior to discharge to the main ETP. .
SCOPE OF SERVICES:
Master Planning, Concept Design, Basic Engineering,
Detail Engineering, Procurement Assistance,
Construction Management, Validation Documentation,
QMS Development & Implementation
SOLID ORAL FORMULATION FACILITY
Pharmax pharmaceuticals, Dubai, UAE
The Facility is designed for manufacturing Oral Solid Dosage
formulations under General category with plans to expand and set up
facilities for the other pharmaceutical dosages in near future. The
Facility is planned in plot of approx. 8715.60 Sq. M. in the industrial
area at Duboitech, Dubai. The facility is designed in compliance with
requirements of the various local authorities like DEWA, DM, and
DCDA, etc and designed to meet cGMP requirements of regulatory
bodies like US FDA, EU and GCC.
SCOPE OF SERVICES:
Master Planning, Conceptual Design, Basic Engineering ,
Detail engineering, procurement assistance, Commissioning
assistance, Documentation & validation Support
When fully operational, this Oral Solid Dosage facility will be capable
of producing 195 million tablets per year & 10 million Capsules (Hard
Gelatine) per year.
The core areas are planned in Modular Panels. The Cooling system is
designed considering the District Cooling system.
20

Case Studies
Finished Dosage Forms
ONCOLOGY OSD & GENERAL OSD FACILITY
Novast Laboratories Ltd., Nantong, China
The project comprises of two separate blocks for producing Oral Solid
Dosage formulations for General and Oncology category of products.
The planned annual capacity of the General products facility is about
2 billion units and that of Oncology products facility is about 70 million
units. The facility has been set up in accordance with regulatory
guidelines of US FDA and other local statutory norms for safety and
building construction regulation.
SCOPE OF SERVICES:
Concept Design, Containment Strategy (For Oncology Facility),
Basic Engineering, Detail Engineering, Procurement Assistance
(For Oncology Facility Process Equipment), Construction
Supervision, Documentation & Validation Support
The Oncology facility has its dedicated Store and Quality Control
departments whereas the General products facility shares these
services with the other existing blocks.
Spectrum on this project worked in coordination with a local design
firm, who supported in development of Structural and Fire Safety
designs as per local codes and supported Novast in applying and
getting required statutory approvals.
VACCINE FILL FINISH FACILITY
A.J. Biologics, Malaysia
This is the first Vaccine production facility coming up in
Malaysia. The proposed facility will be planned, designed,
engineered and operated as per current cGMP standards
of international regulatory authorities of EMEA, PIC/S as
well as conform to all local regulatory requirements.
The facility will be designed to produce liquid injectable in
vials and pre-filled syringes and lyophilised injectable in
vials. The facility will be capable of producing 12.5 million
vials per year of liquid injections, 10 million vials per year of
lyophilised injections and 10 million syringes per year of
liquids in pre-filled syringes.
The facility will also have proper storage units for raw
materials, finished product storage prior to shipment and
other spares and consumables. A proper laboratory
system is also planned to allow quality assurance, quality
control and in-process quality control activities to be
conducted as per regulatory guidelines.
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance, Project Management, Site Supervision,
Commissioning & Startups, Documentation & Validation Support
21

Case Studies
Biopharmaceuticals
SCOPE OF SERVICES:
Project Management
Basic Engineering
Detailed Engineering
Procurement Assistance
ANIMAL FEED ENZYME PRODUCTION FACILITY
TexBioscience Pvt. Ltd., Chennai, India.
TexBioscience is one of the leading producers of enzymes
and has production facilities for textile and animal feed
enzyme.
The facility will be designed as multi-purpose facility to
facilitate manufacturing of animal feed enzymes based on
bacterial and fungal culture. The facility will be designed to
meet HACCP guidelines applicable for Animal feed
manufacturing.
The facility has two separate culture development and
fermentation sections, one each for Fungal and Bacterial
fermentation. There are two 20 KL production fermenters in
each module. The downstream processing involves
Harvesting, Filter Press, Centrifuge as one line and Microfiltration and Spray Drying as the other line. The final enzyme is blended with
diluent and packed.
VACCINE PRODUCTION FACILITY
BIOLOGICAL E. LTD., Hyderabad, India.
Biological E. was established over 50 years ago. It is the first private sector biological products company in India and the first
pharmaceuticals company in South India. BE is also the pioneer in preventive medicine.
The facility will be designed as multi-purpose facility to facilitate manufacturing of bulk vaccines on campaign basis. The facility will be
designed for 100 million doses/ year of each bulk vaccine under cGMP conditions. Required unit operations such as cell propagation,
incubation, Virus infection, virus incubation, harvesting, Media preparation and storage.
The facility will be designed in accordance of containment requirement for managing infectious agents of BSL 2 category. The design
objective is to protect the operators and others from exposure and also to protect the outside environment from potentially
hazardous/infectious agents.
SCOPE OF SERVICES:
Project Management, Basic Engineering , Detailed Engineering, Procurement Assistance, Validation Support
22

Case Studies
Biopharmaceuticals
FERMENTATION FACILITY
Sanzyme Ltd.,Near Hyderabad, India
SCOPE OF SERVICES:
Basic Engineering
Detail Engineering
Procurement Assistance
Site Supervision Support
Validation Support
The facility produces various types of Probiotics. The facility
is designed to meet the internal standards and international
regulatory requirements. Two dedicated blocks one for
probiotic and one for Lactic acid bacillus (LAB block) were
planned in the plot. In addition there block specific areas for
Raw Materials, Packaging Material, Finished products and
Solvents. The support infrastructure such as Quality Control
laboratory, Administration offices, Maintenance areas, ETP,
Utility block, etc. are common for both the block.
INSULIN PRODUCTION FACILITY
Wockhardt. Ltd., Aurangabad, India.
Wockhardt Ltd is one of the leading Pharmaceutical and
Biotech manufacturer in India and also has manufacturing
facilities in US and UK. This facility was the expansion of
their existing facility named as “Plant D, Phase-I”.
The process involved for the LAB block includes
fermentation, separation, drying (Spray drier) and powder
processing. Powder processing area is designed as clean room and having control and monitoring of air as per ISO 8 requirement for
HVAC system.Purified water as per USP grade was installed and was used for cleaning and rinsing of production equipment.
Fermenters, three in numbers of 25KL each were installed in LAB block.
The proposed facility was planned, designed and
engineered as per cGMP standards and shall confirm to all
relevant local statuary/regulatory and c G M P
requirements. The design was done considering phase-II
& phase-III expansions in future. The facility has two sets
of 20 KL, 2KL, 0.2KL & 0.02 KL fermenters & 2 Nos. of 7
KL Harvesters. The layout was planned as G+2 structure
with service area on terrace. Modular & Aerocon panels
were used on all the floors to ease dismantling and
expansion of facility. The utility equipment's were located
on terrace to reduce on pumping energy & associated
piping inventory.
SCOPE OF SERVICES:
Review of Conceptual Design, Basic Engineering , Detail
Engineering, Procurement Assistance, Validation Support
23

Case Studies
Active Pharmaceutical Ingredients
CEPHALOSPORIN CRYSTALLINE STERILE BULK FACILITY
Parabolic Drugs Limited, Derabassi, Punjab.
The facility is designed to produce
'Cephalosporin Crystalline Sterile Bulk' and
has a total built up area of about 1600 Sq.M.
The main block is designed as a ground plus
two storey structure with warehouse and
production area on Ground floor, Technical
area for placement of AHU on first floor and
Utility area on second floor
SCOPE OF SERVICES:
Concept Design, Basic Engineering, Detail Engineering,
Procurement Assistance,
The operations carried out in the sterile area
i.e. from crystallization step onwards thru to
Drying, Filling and Packing is fully
automated and is procured from Omca
Plants Srl. (BA.DO.), Italy.
MULTI PRODUCT SMALL SCALE PRODUCTION & KILO LAB FACILTY
Enaltec Labs, Ambernath, India
The facility was designed as a Multi-Product Small Scale
Production & Kilo Lab facility for manufacturing APIs.
The proposed facility was planned, designed and engineered as
per cGMP standards of international authorities like USFDA,
WHO etc. and confirms to all relevant local statuary/regulatory
and cGMP requirements. The facility design complies with ICH,
NFPA & ISPE guidelines. The facility has eventually received
approval by USFDA.
The project comprised of setting up of Production Block,
Warehouse & Quality Control Block. In addition, the facility has
all necessary ancillary structures like Utility Block, Solvent Drum
Yard, Transformer Yard and Effluent treatment plant.
SCOPE OF SERVICES:
Basic Engineering , Detail Engineering, Procurement
Assistance, Inspection & Expediting, Construction
Management, Validation Support
24

Case Studies
Active Pharmaceutical Ingredients
VITAMIN D3 & ALLIED PRODUCTS FACILITY
Fermenta Biotech, Dahej, India
The scope commenced with Site Master
Planning for setting up of blocks for all
production stages of Vitamin D3, in phases.
The entire project was envisioned to be
developed in four phases commencing with
setting up of API facility in the first phase
with backward integration to Fermentation
facility in the fourth phase.
The overall site to be developed is about
28,000 Sq.M with a total constructed area
of 3000 Sq.M in the first phase. The first
phase of the project was completed in 12
months.
SCOPE OF SERVICES:
Master Planning, Basic Engineering, Detail Engineering, Procurement
Assistance, Site Audits, Construction Management, Commissioning & Start
Up , Validation Support
API FACILITY (HORMONE)
Dr. Reddy's Laboratories (DRL), Vizag, India
The Hormone Manufacturing facility was constructed on an existing
site of DRL. Area of production block is approx. 1500 Sq.M with a
capacity of 50 Kgs/ month. The project cost was completed in 10
months.
The facility has two dedicated self-contained modules for
manufacturing two products simultaneously. The facility was design
for PBOEL (Performance Based Operator Exposure Limit) of 500
ng/cu.m. Based on this risk assessment Containment levels were
decided. Dedicated detoxification reactor is provided to detoxify the
effluent before discharging it to a common Effluent Treatment Plant.
SCOPE OF SERVICES:
Concept Design , Basic Engineering, Detail Engineering,
Procurement Assistance, Site Supervision, Commissioning &
Start up, Validation & Documentation Support
SPECTRUM provided critical inputs during planning stage to
minimize handling of potent product in powder form. The risk
elimination at source technique was used minimizing operator
interface. This facility has been approved by USFDA.
25

Spectrum PharmaTECH
Consultants Pvt. Ltd.
Address:
503, Dosti Pinnacle
Plot E-7, Road No. 22, Wagle Estate
Thane (West)- 400607, India
Tel: +91-22-21580500, Fax: +91-22-21580505
E-mail: engg@spectrumpharmatech.com
Web Site: www.spectrumpharmatech.com