2. MATERIALS OF PHARMACEUTICAL
PLANT CONSTRUCTION
• A wide variety of materials are used for
manufacturing, processing and packaging of
products.
• Some products are highly acidic while some are
highly alkaline. so design of equipment ,material
selection and fabrication techniques need to be
considered carefully.
• These factors affect the success or failure of a
new chemical plant.
3. MATERIALS OF PHARMACEUTICAL
PLANT CONSTRUCTION
• if container is not compaitable with the
material then there are chances of
contamination.
• The proper choice of material is important
• The choice is based on expert advice,
previous experience and laboratory tests
4. MATERIALS OF PHARMACEUTICAL
PLANT CONSTRUCTION
• FACTORS AFFECTING DURING MATERIALS
SELECTED FOR PHARMACEUTICAL PLANT
CONSTRUCTION
• Chemical factors
• Physical factors
• Economic factors
5. CHEMICAL FACTORS
• Each time a chemical placed in the container
or equipment is exposed to the construction
material of the same.
• so construction material can contaminate the
product or the product can destroy the
construction.
6. CONTAMINATION OF THE PRODUCT
• Iron contamination can change the color of
products such as gelatin capsules.
• It catalyzes some reactions that can increase
the decomposition rate of the product.
• The leaching of glass makes the aqueous
product alkaline. This alkaline medium can
catalyze the decomposition of the product
e.g. lead inactivate penicillin
7. CORROSION OF MATERIAL OF
CONSTRUCTION
• The product can be corrosive in nature. They
can react with the material and can destroy it.
This shortens the life span of the equipment.
• Extreme PH, strong acids, strong alkalis,
powerful oxidizing agents, tannins etc react
with the materials and adversely affect them.
8. PHYSICAL FACTORS
1. STRENGTH:
• The materials must have sufficient physical
strength to withstand the pressure and stress
required
• Iron and steel have sufficient physical strength
• The tablet punching machine, the die, and the
upper and lower punches – made of stainless
steel(withstand high pressure)
9. PHYSICAL FACTORS
• 1. STRENGTH:
• The aerosol container must withstand high
pressure .so tin containers covered with some
polymers are used
• Plastic materials are weak-used for packaging
materials such as blister packs
10. MASS
• For transportation, light weight materials are
used.
• Plastic, aluminum, and paper packaging
materials are used for the packaging of the
pharmaceutical products.
11. WEAR PROPERTIES
• When there is friction occurs between two
surfaces, the softer surface disappears and
these materials contaminate the products.
E.g. during milling and grinding operations
grinding surfaces can wear out and
contaminate the powder.
• For handling pharmaceutical products
ceramics or iron are not used
12. THERMAL CONDUCTIVITY
• The materials should possess good thermal
conductivity
• Equipments such as dryers, evaporators, heat
exchangers-iron ,copper or graphite tubes are
used
13. THERMAL EXPANSION
• If the material has a very high coefficient of
thermal expansion, as the temperature
increases the shape of the equipment
changes. This produces unequal stresses
cause fracture.
• The materials that are capable of maintain
the shape and dimension of the equipments
at the working temperature should be used.
14. EASE OF FABRICATION
• Glass and plastic can be easily molded in to
containers of different shapes and size
15. CLEANING:
• Smooth and polished surfaces facilitate ease
in cleaning
• The surfaces of glass and stainless steel can be
smooth and polished
16. STERILIZATION
• In the production of parenterals, ophthalmic
and bulk drugs all equipment must be
sterilized.
• This is usually done by introducing high
pressure steam.
• The materials must withstand high
temperature(121° c) and pressure 15 pounds
per square inch
17. TRANSPARENCY
• In the reactors and fermentors observation
window provided to observe the progress of
the process.
18. ECONOMIC FACTORS
• The initial cost of the equipment depends on
the material used
• The materials that require a lower
maintenance cost are used because in the
long term it is economical.