SPECTRUM PHARMATECH CONSULTANTS - NEW COMPANY PROFILE

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
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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.