Materials of Pharmaceutical Plant Construction

There are a variety of equipment required when manufacturing pharmaceuticals, bulk drugs, antibiotics, and biological products. These equipment are mostly used for packaging and processing the products. For the manufacture of these equipment, many different materials are used. Acidic and alkaline materials are used for manufacturing these equipment. For instance, biological products need to be handled carefully.

Consequently, the selection of materials, the design of the equipment, and the fabrication technique must be carefully considered. They determine whether a new chemical plant succeeds or fails. A container that is not sized correctly can lead to contamination. Therefore, proper material selection is essential for the construction of processing equipment, containers for storing finished products, and closers for closing them. In making this decision, you should consider expert guidance, experience, and a laboratory test.

Construction of a Pharmacy Plant: Factors Affecting Material Selection

Materials that are used to construct the equipment are selected according to their following properties:

Economic Factors

Initial equipment costs are determined by the materials used. Construction can be done with several materials, but only the least expensive one is used. It is more economical long-term to use materials with low maintenance costs. Materials used for building a plant can be divided into metals (ferrous and non-ferrous) and nonmetals (organic and inorganic).

Chemical Factors

Chemicals are exposed to the construction material of containers and equipment each time they are placed in them. Because of this, the construction material may contaminate the product (contamination) or may cause the product to corrode (corrosion).

Corrosion of Materials of Construction

There may be corrosive products present. Their reaction with the material can damage the material. Destroying the material will reduce its lifespan. A strong acid, a strong alkali, a powerful oxidizer, tannins, etc., react with these materials, so alloys with special chemical resistance are being used to resist strong acids, strong alkalis, powerful oxidizers, etc.

Contamination of Products

Products contaminated with iron can change color (like gelatin capsules), and catalyze some reactions which can accelerate decomposition. Aqueous products can become alkaline after leaching of glass. By using an alkaline medium, the product may decompose faster. Penicillin is inactivated by heavy metals like lead.

Physical Factors

Wear Properties

Friction between two surfaces causes the softer surface to disappear and contamination to occur. A worn-out grinding surface, for example, can contaminate the powder during milling and grinding. The use of ceramic and iron surfaces for grinding pharmaceutical products of high purity is not recommended.

Thermal Expansion

If the material of the equipment has a high thermal expansion coefficient, its shape will change as the temperature increases. Inequal stresses result, causing fractures. Therefore, equipment should be made from materials that can maintain their shape and dimensions at working temperatures.

Mass

Materials that are lightweight are used in packaging for transportation. Pharmaceuticals are packaged with materials such as plastic, aluminum, and paper.

Thermal Conductivity

The materials that are used in evaporators, dryers, stills, and heat exchangers need to have excellent thermal conductivity. Graphite, copper, or iron tubes are used in this case for efficient heat transfer.

Strength

To withstand pressure and stress, the material must be sufficiently strong. These properties can be met by steel and iron. In order to handle extremely high pressure, the punching machine, die, and upper and lower punches are made of stainless steel. Although strong, glass is fragile. A tin container covered with some polymers (lacquered) is used for aerosol containers because of the high pressure they must withstand. Some packaging materials, such as blister packs, have been made from plastic materials due to their weakness.

Cleaning

Surfaces that are smooth and polished are easier to clean. In order to ensure that the next product is not contaminated by the previous one, the equipment is thoroughly cleaned after the operation. Stainless steel and glass surfaces can be polished and smoothed.

Ease of Fabrication

Equipment is made from a variety of materials that undergo a variety of processes, such as casting, welding, and forging. Glass and plastic, for example, can easily be molded into containers of any size and shape. It can be used in reaction vessels as an insulating material.

Sterilization

All equipment used for the production of parenterals, ophthalmics, and bulk drugs needs to be sterilized in order to prevent contamination by microbes. The most common method is to use high-pressure streams. For materials to endure high temperatures (121°C) and pressures (15 pounds per square inch), they must be heat resistant. To be able to withstand light temperatures, rubber materials must be vulcanized.

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