Gestion De Inventario

SYNTHESIZED PHARMACEUTICAL MANUFACTURING PLANTS
A. PROCESS DESCRIPTION
The synthesis of medicinal chemicals may be done in a very small facility producing only one
chemical or in a large integrated facility producing many chemicals by various processes. Most
pharmaceutical manufacturing plants are relatively small. Organic chemicals are used as raw
materials and as solvents. Nearly all productsare made using batch operations. In addition,
several different products or intermediates are likely to be made in the same equipment at
different times during the year; these products, then, are made in “campaigned” equipment.
Equipment dedicated to the manufacture of a single product is rare, unless the product is made
in large volume.
Production activities of the pharmaceutical industry can bedivided into the following categories:
1. Chemical Synthesis - the manufacture of pharmaceutical products by chemical synthesis.
2. Fermentation - the production and separation of medicinal chemicals such as antibiotics and vitamins from microorganisms.
3. Extraction - the manufacture of botanical and biological products by the extraction of
organic chemicals from vegetative materials or animaltissues.
4. Formulation and Packaging - the formulation of bulk pharmaceuticals into various
dosage forms such as tablets, capsules, injectable solutions, ointments, etc., that can be
taken by the patient immediately and in accurate amount.
Production of a synthesized drug consists of one or more chemical reactions followed by
a series of purifying operations. Production lines may contain reactors,filters, centrifuges,
stills, dryers, process tanks, and crystallizers piped together in a specific arrangement. Arrangements can be varied in some instances to accommodate production of several compounds. A very small plant may have only a few pieces of process equipment but a large plant
can contain literally hundreds of pieces.
Exhibit 1 shows a typical flow diagram for a batch synthesisoperation. To begin a production
cycle, the reactor may be water washed and perhaps dried with a solvent. Air or nitrogen is
usually used to purge the tank after it is cleaned. Following cleaning, solid reactants and
solvent are charged to the glass batch reactor equipped with a condenser (which is usually
water-cooled). Other volatile compounds may be produced as product or by-products. Any
remainingunreacted volatile compounds are distilled off. After the reaction and solvent removal
are complete, the pharmaceutical product is transferred to a holding tank. After each batch is
placed in the holding tank, three to four washes of water or solvent may be used to remove any
remaining reactants and by-products. The solvent used to wash may also be evaporated from
the reaction product.
EXHIBIT 1:Typical Synthetic Organic Medicinal Chemical Process
The crude product may then be dissolved in another solvent and transferred to a crystallizer for
purification. After crystallization, the solid material is separated from the remaining solvent by
centrifugation. While in the centrifuge the product cake may be washed several times with

water or solvent. Tray, rotary, or fluid-bed dryers may thenbe employed for final product finishing.
B. SOURCES OF POLLUTION
Exhibit 2 identifies pollutants from a typical pharmaceutical process. Volatile organic compounds may be emitted from a variety of sources within plants synthesizing pharmaceutical
products. The following process components have been identified as VOC sources and will be
discussed further: reactors, distillation units, dryers,crystallizers, filters, centrifuges, extractors, and tanks.
1. Reactors
The typical batch reactor is glass lined or stainless steel and has a capacity of 2,000 to 11,000
liters (500-3000 gallons). For maximum utility the tanks are usually jacketed to permit temperature control of reactions. Generally, each tank is equipped with a vent which may discharge
through a condenser. Batch reactors can be...