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Introduction:

This proposal is a response to your request pertaining to the


design and manufacturing of a mixing element for your
pharmaceutical industry. Your request was properly analyzed by
our technical department and assessed on the basis of our
availability of services and equipment. It is with great pleasure
that we inform you that your specifications lie well within our
expertise and resources. Our industry is capable enough to
develop the machine tailored to your specifications. We have
previously made mixing-machines for various process industries
including pharmaceuticals and all have been technically
appraised.

Background Information:
From the specifications and data charts provided to us we have
derided the following problem statement:
Development of a mixer specified for pharmaceutical
components with the aim to blend the actual medicine in a
quantified proportion with the salt. The proportion being 5mg of
medicine in a 5g pill.
The aforementioned task is challenging as is the manufacturing of
any component that comes in direct contact with the consumerbased medicines and where chemistry of regents is involved.
Tolerance limit in such cases are negligible as in addition to the
exact mixing specified by the company and approved by FDA we
have to take into account the fact that every particulate is
reactive. So we have to be extra cautious in choosing the
materials involved in manufacturing.

Objectives:
Our main objectives for this project constitute:
1) Development of an effective mixing equipment to blend
the salt and actual medicine.

Equipment must be

Located
Designed
Constructed
Adapted
maintained

to suit the operations to be carried out.


Equipment layout and design must aim:
to minimize risks of error
to permit effective cleaning and maintenance
To avoid:
cross-contamination, dust and dirt build-up
any adverse effect on the quality of products
Equipment must be installed to:
Minimize risks of error
Minimize risks of contamination

2) Optimize the resources involved thereby becoming cost


effective
3) Material Selection keeping in consideration the unique
chemistry of the ingredients involved.
No hazard to the products
contact parts of suitable non-reactive materials
non additive and
not absorptive

4) Timely completion

Technical Approach:
Mixing in industrial terminology may be defined as a unit operation
that aims to treat two or more components initially in an unmixed or
partially mixed state, so that each unit of components lies as nearly as
possible in contact with a unit of the components

Our aim is thorough and uniform mixing. Initially two silos will be
constructed for the storage of the ingredients. One for the salt
and the other for the medicine, each will have an opening in the
main mixer.
The body of silos and containers will be made via Fluoropolymers
because of its outstanding friction reduction, material release,
chemical resistance, and thermal stability, fluoropolymers,
especially Teflon perfluoropolymers, have found increasing
applications as materials of construction in the pharmaceutical
and biotechnology industries. These adoptions showcase its anticorrosive and non-wetting surface characteristics, enhanced by its
reduced surface friction.
Silos will have shafts for the transfer of material to the mixer via
valves which will be controlled by autonomous systems to ensure
proper proportion is sent to the mixer.

Mixer:
A planetary type mixer will be used made of less reactive
stainless steel. It will have two blades which rotate on their own
axis while they orbit the mix vessel on a common axis. The blades
continuously advance along the periphery of the vessel, removing
material from the vessel wall and transporting it to the interior.

Scope of Work:
An initial model will be developed through our design department.
It will be approved after thorough analysis and computer
simulations which include material testing and sheer analysis. It
will be then sent to our manufacturing department which will

fabricate the material body and blades of the mixer. Assembly will
be done next. Pneumatically controlled and electronically handled
control valves will be introduced in the shafts extruding from silos.
The material will be tested through NDTs for final validation.
Performance qualification
Verifies that the equipment performs according to design
specifications and user defined requirements in a reliable
and reproducible manner under normal production
conditions.
Verified in accordance with a performance qualification
protocol
Documented records performance qualification report
Show satisfactory performance over a period of time i.e.
carried out long enough to prove that the equipment is
under control and turns out product of specified quality
consistently.
Manufacturers to justify the selected period

Project Team:
The project team will be comprised of a project head, who has a
tremendous experience in handling delicate projects. He will have
all the department heads working under him.
1) Design Team:
5 qualified draftsman, 2 engineers and a computer technician
working under the Design head.
2) Analysis Team:
2 Simulations experts , 3 analytical engineers working under the
analysis head.
3) Manufacturing Team:
Project heads working in Casting, Forging, Fabrication, Foundary

and Machining Departments with nearly 50 technical experts


distributed among the departments.
4) Systems Engineers who will look after the control valves and
the electronics involved.
5) Testing team proficient in Material Validation and testing.

Schedule:
October-November
November-December
December-January
January-February
February-March
April

Cost:
Two Silos
Blades
Mixer body
Control Valves
Shafts
Extraction
Assembly

Design and Modeling


Simulations
Analysis
Manufacturing
Material Testing
Final Validation and
Dispatch

3,000
2,000
1,000
2,000
1,000
1,000

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