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Practice 14

The document outlines the process of industrial production of paracetamol, detailing each step from the preparation of materials to the final product. It includes a block flow diagram illustrating the reaction and separation stages, emphasizing the importance of purification and quality control throughout the process. The final verification step ensures that the system is clean and ready for the next production cycle, adhering to Good Manufacturing Practices.

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0% found this document useful (0 votes)
50 views6 pages

Practice 14

The document outlines the process of industrial production of paracetamol, detailing each step from the preparation of materials to the final product. It includes a block flow diagram illustrating the reaction and separation stages, emphasizing the importance of purification and quality control throughout the process. The final verification step ensures that the system is clean and ready for the next production cycle, adhering to Good Manufacturing Practices.

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Fabiola OR
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© © All Rights Reserved
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UNIVERSIDAD NACIONAL DEL CENTRO DEL PERÚ

FACULTAD DE INGENIERÍA QUÍMICA

ESCUELA PROFESIONAL DE INGENIERÍA QUÍMICA

INDUSTRIAL

“PRACTICE 14: INNOVATIONS IN CHEMICAL


INDUSTRY: INORGANIC INDUSTRIAL
CHEMISTRY”
COURSE:
093D – ENGLISH I
TEACHING:
ING. ROMERO REY AMANDA LUZ
STUDENTS:
AGUILAR FLORE MARGOTH
ARMAS LAZO, LUCERO ANA CRISTINA
OLARTE RAMOS FABIOLA SHANTALL

HUANCAYO _ PERÚ

2025
PRACTICE 14:

INNOVATIONS IN CHEMICAL INDUSTRY:

INORGANIC INDUSTRIAL CHEMISTRY

INSTRUCTIONS: Choose a chemical (the one of your choice), write a description of


the process, and draw it on a block flow diagram of the reaction and separation steps.
Examples: aspirin, penicillin, paracetamol, etc.

PARACETAMOL PROCESS
Paracetamol, also known as acetaminophen, is a medication widely used for its
analgesic and antipyretic properties. Its industrial production is based on a series of
well-defined chemical and physical-chemical steps, ensuring the purity and efficacy of
the final product. The complete production process, from the initial reagents to the
packaged product, is described below.
1. DESCRIPTION OF THE PROCESS
The paracetamol manufacturing process, as represented in the document's
flowchart, is based on an orderly sequence of operations that include chemical
reaction and product purification stages.
1.1. START
The process begins with the preparation of the operating system, ensuring
that the equipment is clean, the materials are available, and the reagents are
ready for use. This step involves a prior review of the procedure, safety
conditions, and verification of the proper functioning of the reactor and other
instruments.
1.2. Allow flow from the p-aminophenol tank to the purifier
In this step, p-aminophenol, the main reactant, is transferred from its storage
tank to a pre-purification unit, if necessary. This is done to remove
impurities that could interfere with the subsequent acetylation reaction.
According to references for industrial pharmaceutical processes (Good
Manufacturing Practices, WHO), the inputs must meet quality specifications
before entering the reactor.
1.3. Purifie
An initial purification of the p-aminophenol is performed here, which may
include filtration, pH adjustment, or moisture removal. This step ensures that
the input material has the appropriate purity, concentration, and stability
conditions to react efficiently.

1.4. Allow flow from the acetic acid, acetic anhydride and p-
aminophenol tank to the reactor
Once purified, the main reagents acetic anhydride (acetylating agent), acetic
acid (can act as a medium or stabilizer) and p-aminophenol are sent to the
chemical reactor to carry out the main reaction.
1.5. Loading of Reactants and Reaction Conditions
The reactor is loaded with the main reactants: p-aminophenol (paracetamol
precursor) and acetic anhydride (acetylating agent), along with potential
catalysts or solvents such as glacial acetic acid. The acetylation reaction is
conducted under controlled conditions:
 Temperature: Between 70°C and 90°C to optimize reaction rate
without thermal degradation.
 Constant agitation: Ensures mixture homogeneity and promotes heat
transfer.
 Residence time: Typically 4 to 6 hours, depending on scale, to ensure
complete conversion.
During this stage, p-aminophenol is converted into paracetamol
through amide bond formation, releasing acetic acid as a byproduct.
1.6. Reaction Monitoring and Control
Analytical techniques (e.g., HPLC or IR spectroscopy) are used to verify
reactant conversion and intermediate purity. pH may be adjusted to minimize
impurities (e.g., undesired hydrolysis of acetic anhydride).
1.7. Transfer to the Separator or Downstream Stage
Upon reaction completion, the reactor contents (a suspension or solution
containing crude paracetamol, residual acetic acid, and potential byproducts)
are pumped to a separator or neutralization tank. This step may include:
 Controlled cooling: To precipitate paracetamol and facilitate separation.
 Addition of water or activated carbon: In some processes, the mixture is
diluted or impurities are adsorbed.
1.8. Separation process
Once the reaction between para-aminophenol and acetic anhydride is
complete in the reactor, the resulting mixture contains: Paracetamol, acetic
acid, and possible traces of unconsumed reactants.
The separation process aims to isolate paracetamol from the remaining
components using physical and chemical techniques, such as:
 Crystallization: a common technique, since paracetamol has limited
solubility in cold solvents. The mixture is cooled to precipitate the
paracetamol.
 Filtration: to separate the solid paracetamol crystals from the mother
liquor (which contains acetic acid and other impurities).
Decantation or liquid-liquid extraction (in more advanced or continuous
processes).
1.9. Allow flow from the separator to the paracetamol and acetic acid
tanks:
Once the separation is complete, the components are redirected to their
respective storage tanks:Once the separation is complete, the components are
redirected to their respective storage tanks:
 Tanque de paracetamol: recibe el producto sólido o líquido ya separado,
el cual puede requerir una etapa adicional de secado si se obtiene por
 Paracetamol tank: Receives the already separated solid or liquid product,
which may require an additional drying step if obtained by
crystallization.
 Acetic acid tank: This byproduct can:
 Be reused if recovered under appropriate conditions.
 Be treated as waste if it contains contaminants.
1.10. Verification - End of process:
Before completing the production cycle, a final check is performed to
confirm that all material has been evacuated from the system, in this case,
from the purifier. This check can be done manually or with level sensors and
is essential to ensure that no traces of compounds remain inside the pipes or
equipment. This practice prevents problems such as cross-contamination
between batches, waste accumulation, or product loss that could interfere
with the quality of the next batch.
This stage is a requirement within Good Manufacturing Practices (GMP), as
it guarantees the cleanliness of the system and allows for the implementation
of clean-in-place (CIP) protocols. Only when the system is completely
empty and safe is the cycle considered complete and preparation for new
production can begin. This practice reflects the pharmaceutical industry's
commitment to the safety, quality, and efficiency of industrial processes.

2. BLOCK FLOW DIAGRAM OF THE REACTION AND


SEPARATION STEPS.

START

Permitir flujo desde


tanque de para-
Aminofenol al purificador

FULL
PURIFIE NO
R

SI

PURIFIE

Allow flow from the acetic acid


tank, acetic anhydrous acid
tank, and purifier to the reactor
FULL
REACTOR
SI NO

GENERAR
REACCION

ALLOW FLOW FROM THE


REACTOR TO THE SEPARATOR

EMPTY
REACTOR
NO

SI

SEPARATION
PROCESS

Allow flow from the


separator to the paracetamol
and acetic acid tanks

EMPTY
PURIFIE
NO

SI

END

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