|
Case Studies
Laboratory and R&D
Setting up Pharmaceutical laboratories requires lot of parameters,
appropriate guideline with cost effective parameters by consultants or respective
project manager. Ajit G Kadam General Manager, Lab Projects, Spectrum
PharmaTECH Consultants reveals the case studies which have been undertaken by
Spectrum PharmaTECH
1) Laboratory and R&D
Lab and R&D Facility Novartis Healthcare., Thane, India
Spectrum designed and engineered a global research and development laboratory
and pilot scale manufacturing facility for Novartis healthcare.
The main sections built in the centre were:
- Analytical Laboratory
- Wet Chemistry Lab
- Pilot Plant for OSD, Liquids & Semisolids.
- Stability Chambers' section
- Offices for Chemists
- Utility Area
The project was done in existing building. Approximate area
of the facility is 12,500 square feet. Facility was planned to accommodate 25
chemists. All utilities such as lab gases and air compressors were located on
Terrace. The major constraint in the project was that the Lab was located on
fifth floor and all the utilities had to pass through the sixth floor to reach
the Labs. This project was completed in record time of 10 Months and within
budgeted cost of Rs 180 million. Spectrum's scope of services included basic
engineering, detailed engineering, procurement assistance, commissioning and
validation support.
The facility was appreciated as a state of the art facility
and was qualified by Novartis, Switzerland's quality control department.
Scope of services:
- Concept Design
- Basic Engineering
- Detail Engineering
- Procurement Assistance
- Inspection and Expedition
- Site Audits
- Commissioning and Start Up
- Validation
Laboratory and R&D
Lab and R&D facility Novartis Healthcare Pvt. Ltd., Thane,
India.
This pilot scale manufacturing facility for solids, liquids
and ointments was set up at a project cost of Rs 450 million and in a time span
of 20 months. Services provided by Spectrum include basic engineering, detailed
engineering, procurement assistance, commissioning and validation support and
construction management. 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 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 were consists main sections like-
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.
The special feature of this project is the containment solutions
provided to handle PBOEL3B compounds with various containment devices and specifically
designed equipments. The HVAC design for this plant is unique and is designed
to meet not only these containment objectives but also satisfy the stringent
environmental protection requirements in view of its close proximity to residential
areas.
2) Laboratory and R&D
LAB and R&D Facility Janssen Cilag Pharmaceuticals (Johnson
& Johnson), Mumbai, India
Ajit G Kadam General Manager, Lab Projects, Spectrum PharmaTECH
Consultants reveals about J&J's plans, Johnson & Johnson wanted to set
up the global R&D centre, laboratory facility for solids, liquids and ointments
for its pharma business in India.
The main sections of the centre were:
- Analytical Laboratory
- Wet Chemistry Lab
- Administrative Area
- Utility Area
- Stability Study Area
- PBOEL 4 Sampling Facility
The R&D centre was built in an existing 30 year building,
with a clear height of only 3.6 mtrs. The total area developed was about 18000
Square feet. The facility was planned to accommodate 40 Chemists. The lab was
equipped with 60 HPLCs and four stability chambers with all associated utilities.
This project was completed in record time of 10 Months with a cost of Rs 300
million. Services provided by Spectrum were basic engineering, detailed engineering,
procurement assistance, commissioning and validation support. This was a unique
project executed by Spectrum, as there were specific Environment Health and
Safety (EH&S) and Quality issues to be followed right from the design stage.
Since the height was very low it a challenge to accommodate the HVAC and other
utilities.
Scope of services:
- Concept Design
- Basic Engineering
- Detail Engineering
- Procurement Assistance
- Inspection and Expediation
- Site Audits
- Commissioning and Start Up
- Validation
|
