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Social impact of The
Pharmaceutical Industry
ensuring health in social and
community development.Presented by Miss Sudipta Roy
Designation: Assistant Professor
Email: sudiptaroy89@gmail.com
Place: Department of pharmaceutics
Northern Institute of Pharmacy and
Contents.
• Aim and objective.
• Abstract.
• Introduction
• Pharmaceutical products and it's role.
• Pharmaceutical agents.
• Pharmaceutical unit operation.
• Pharmaceutical manufacturing process for
bulk drug.
• Pharmaceutical manufacturing process for
Contents.
• Pharmaceutical safety hazards to workers.
• Role of Pharmaceutical industry collaboration
in implementing development of social and
community affairs.
• Conclusion.
• References.
Aim and objective.
• To ensure healthy human life as well as
environmental sustainability for social and
community development.
Abstract.
• Health is a critical challenge for society on
basis of economic asset of people.
Pharmaceutical industries and it's
manufacturing products have been impacting
health related issues for social and community
development in major issues of reducing child
and maternal mortality, slowing the spread of
HIV/AIDS, malaria, tuberculosis, malnutrition
of children promoting gender equality and
empowerment.
Abstract.
• Here in this poster presentation, the
fascinating role with its different
manufacturing process for different types of
dosage form of the pharmaceutical industry
have been presenting for development of
social care.
Introduction.
• There is important difference between
developed and developing countries according
to their needs for pharmaceutical substances.
Malnutrition and infectious diseases are major
cause of developing countries where
nutritional supplements, vitamins and anti-
infective drugs are most needed.
Introduction.
The diseases related to ageing are primary
health concerns in developed countries and
some specific diseases associated with
cardiovascular, central nervous system,
gastrointestinal, anti-infective, diabetes and
chemotherapy drugs are mostly required.
Introduction.
• Drugs used for health of human and animal
care is being prepared by same R&D activities
and manufacturing processes.
• Synthesized products having unique
therapeutic benefits and mechanisms have
been gone through their approval,
distribution, marketing and sales process.
Pharmaceutical products and it's
role.
• Biological products: Bacterial and viral
vaccines, antigens, antitoxin, analogous
products, serums, plasma and other blood
derivatives.
• Role: To protect therapeutically.
• To treat humans or animals.
Bulks: Active drug substance.
Role: To manufacture dosage form for animal
feeds, compound prescription medications.
Pharmaceutical products and it's
role.
• Diagnostic agents: These substances may be
inorganic chemicals, radioactive compounds.
• Role: To assist diagnosis of diseases, disorders
in human and animals.
• To examine human organs like G. I. tract,
circulatory system, liver etc.
Pharmaceutical products and it's
role.
• Drugs: These substances are
pharmacologically active and compounded
with others materials.
Role: To produce medicinal products.
Ethical pharmaceuticals: These substances are
biological, chemical agents.
Role: To prevent, diagnosis, treat diseases and
disorders in humans or animals.
Pharmaceutical products and it's
role.
• Excipients: These are inert ingredients.
• Role: To make combination with drug
substances to create a dosage form products.
• To help dosage form by affecting and
controlling rate of absorption, dissolution,
metabolism, distribution.
Pharmaceutical products and its
role.
• Over the counter pharmaceuticals: These
substances are drug products sold in retail
store/pharmacy.
Role: Without a prescription or the approval of a
medical, pharmacy or veterinary professional,
these drug products is being dispensed to a
patient.
Pharmaceutical agents.
• Biological agents: The pharmaceutical industry
uses biological agents, such as bacteria and
viruses in many special applications like
vaccine production, fermentation process,
derivation of blood based products and
biotechnology.
• Chemical agents: These are divided into
industrial chemicals and drug related
substances that may be raw materials,
intermediates or finished products.
Pharmaceutical agents.
• Industrial chemicals: These are used in
researching and developing active drug
substances and manufacturing bulk
substances, finished pharmaceutical products.
Organic and inorganic chemicals are raw
materials, serving as reactants, reagents,
catalyst and solvents.
• Drug related substances:
These are pharmacologically active products are
divided into natural products and synthetic
Pharmaceutical agents.
• Source of natural products are plant and
animal sources. Examples are antibiotics,
steroid, peptide hormones, vitamins,
enzymes, prostaglandins, pheromones.
• Source of synthetic products are from
microbiological and chemical technologies.
• Pharmaceutical inactive ingredients: These are
mixed with active drug substances providing
desired physical and pharmacological
properties in the dosage form products.
• Diluting agents, ointment bases,
pharmaceutical solvents and excipients.
Pharmaceutical unit operations.
• Weighing and dispensing: To weigh and
dispense of solids and liquid is a very common
activity through out pharma industry.
• This operation must be performed in a
partitioned work place area with good
dilution, ventilation.
• Weighing surfaces must be smooth and sealed
to give proper cleaning.
• To weigh and dispense highly toxic materials
may require additional control measures. Eg.
Pharmaceutical unit operation.
• Charging and discharging solids and liquids:
• These phenomenon are frequently happened
through charged and discharged containers
and process equipment in pharmaceutical
manufacturing operation.
• This operation may be performed manually by
workers or by other methods such as gravity,
mechanical/pneumatic transfer systems.
Pharmaceutical unit operation.
• Liquid separations: liquids are separated
based upon their physical properties.
• Eg. Density, solubility, miscibility.
• Liquid separations are commonly performed
during bulk chemical production,
pharmaceutical manufacturing operations.
• Hazardous liquids should be transferred,
processed, separated in closed vessel and
piping systems to reduce worker exposure to
liquid spills and airborne vapours.
Pharmaceutical unit operation.
• Transferring liquids:
• Liquids are frequently transferred between
storage vessels, containers and process
equipment during pharmaceutical
manufacturing operations.
• Sealed vessels and containers and piping
system are highly desirable when transferring
large volumes of liquids with precautions for
inert gases pressurizing transfer lines/process
equipment.
Pharmaceutical unit operation.
• Filtration:
• Solids and liquids are separated during
filtration operations. Filters have different
designs and features. When open filters are
used for hazardous materials, workers may be
exposed to liquids, wet solids, vapours and
aerosols during loading and unloading
operations. Closed process equipment can be
used to filter highly hazardous materials,
reducing vapour emissions and preventing
Pharmaceutical unit operation.
• Compunding.
• Solids and liquids are mixed in compounding
operations to produce solutions, suspensions,
syrups, ointments and pastes. Buffering
agents, detergents and germicides that are
neutralizing, cleaning and biocidal agents may
be hazardous to workers. Eyewashes and
safety showers reduce injuries, if workers
accidentally contact corrosive or irritating
substances.
Pharmaceutical unit operation.
• Granulation:
• Dry and wet solids are granulated to change
their physical properties.
• Granulators have different designs and
features with varying containment and control
of mechanical hazards.
• Enclosed granulators can be vented to air-
control devices, reducing emissions of solvent
vapours or dusts to the workplace and
atmosphere.
Pharmaceutical unit operation.
• Material-handling concerns arise when
loading and unloading granulators.
Mechanical equipment (e.g., elevated
platforms, lift tables and pallet jacks) assists
workers to perform heavy manual tasks.
Eyewashes and safety showers are needed, if
workers accidentally contact solvents or
irritating dusts.
Pharmaceutical unit operation.
• Drying:
• Water- or solvent-wet solids are dried during
many pharmaceutical manufacturing
operations. Dryers have different designs and
features with varying containment and control
of vapours and dusts . Flammable solvent
vapours and explosive airborne dusts may
create flammable or explosive atmosphere;
Pharmaceutical unit operation.
• Milling:
• Dry solids are milled to change their particle
characteristics and produce free-flowing
powders. Mills have different designs and
features with varying containment and control
of mechanical hazards and airborne dusts .
Prior to milling materials, their physical
properties and hazards should be reviewed or
tested.
Pharmaceutical unit operation.
• Blending:
• Dry solids are blended to produce
homogeneous mixtures. Blenders have
different designs and features with varying
containment and control of mechanical
hazards and airborne dusts . Worker
exposures to drug substances, excipients and
blends may occur when loading and unloading
blending equipment.
Pharmaceutical unit operation.
• Compression:
• Dry solids are compressed or slugged to
compact them, changing their particle
properties. Compression equipment has
different designs and features with varying
containment and control of mechanical
hazards and airborne dusts Compression
equipment may pose serious mechanical
hazards if inadequately guarded. High noise
levels may also be produced by compression
Pharmaceutical unit operation.
• Solid dosage form manufacturing:
• Tablets and capsules are the most common
oral dosage forms. Compressed or moulded
tablets contain mixtures of drug substances
and excipients. These tablets may be uncoated
or coated with solvent mixtures or aqueous
solutions. Capsules are soft or hard gelatin
shells. Tablet presses , tablet-coating
equipment and capsule-filling machines have
different designs and features with varying
Pharmaceutical unit operation.
• Sterile manufacturing:
• Sterile products are manufactured in
pharmaceutical manufacturing plants with
modular design , clean workplace and
equipment surfaces, and high efficiency
particulate air (HEPA) filtered ventilation
systems.
Pharmaceutical unit operation.
• Cleaning and maintenance activities:
• cleaning, repairing and maintaining
equipment, utilities and workplaces. Although
unique hazards may arise during non-routine
tasks, recurring health and safety concerns are
encountered. Workplace and equipment
surfaces may be contaminated by hazardous
materials and drug substances, requiring them
to be cleaned before unprotected workers
conduct servicing or maintenance work.
Pharmaceutical unit operation.
• Cleaning is performed by washing or wiping
liquids and sweeping or vacuuming dusts. Dry
sweeping and blowing solids with compressed
air are not recommended, since they create
high worker exposures to airborne dusts. Wet
mopping and vacuuming reduce worker
exposures to dusts during cleaning activities.
Vacuum cleaners with HEPA filters may be
needed when cleaning hazardous substances
and high-potency drugs. Explosion-proof
Pharmaceutical unit operation.
• Packaging:
• Finished dosage-form products may be
packaged in many different types of
containers (e.g., plastic or glass bottles, foil
blister packs, pouches or sachets, tubes and
sterile vials). The mechanical equipment fills,
caps, labels, cartons and packs the finished
products in shipping containers.
Pharmaceutical unit operation.
• Laboratory operations:
• Lab workers may conduct scientific research to
discover drug substances, develop
manufacturing processes for bulk chemical
and dosage-form products or analyze raw
materials, intermediates and finished
products. Clearly defined responsibilities,
training and information, safe work practices
and control measures and emergency
response plans are important means for
Pharmaceutical manufacturing
process for bulk drug.
• Pharmaceutical manufacturing process is
basically of three major types of processes:
fermentation, organic chemical synthesis, and
biological and natural extraction.
• Antibiotics, steroids and vitamins are
produced by fermentation, whereas many
new drug substances are produced by organic
synthesis. Historically, most drug substances
were derived from natural sources such as
plants, animals, fungi and other organisms.
Pharmaceutical manufacturing
process for bulk drug.
Pharmaceutical manufacturing
process for bulk drug.
• Fermentation:
• Fermentation is a biochemical process
employing selected micro-organisms and
microbiological technologies to produce a
chemical product. Batch fermentation
processes involve three basic steps: inoculum
and seed preparation, fermentation, and
product recovery or isolation.
Pharmaceutical manufacturing
process for bulk drug.
• Fermentation:
Pharmaceutical manufacturing
process for bulk drug.
• Chemical synthesis:
• Chemical synthesis processes use organic and
inorganic chemicals in batch operations to
produce drug substances with unique physical
and pharmacological properties. Typically, a
series of chemical reactions are performed in
multi-purpose reactors and the products are
isolated by extraction, crystallization and
filtration. The finished products are usually
dried, milled and blended. Organic synthesis
Pharmaceutical manufacturing
process for bulk drug.
Pharmaceutical manufacturing
process for bulk drug.
• Biological and natural extraction:
• Large volumes of natural materials, such as
plant and animal matter, may be processed to
extract substances which are
pharmacologically active. In each step of the
process, the volumes of materials are reduced
by a series of batch processes, until the final
drug product is obtained.
Pharmaceutical manufacturing
process for dosage form.
• Drug substances are converted into dosage-
form products before they are dispensed or
administered to humans or animals. Active
drug substances are mixed with
pharmaceutical necessities, such as binders,
fillers, flavouring and bulking agents,
preservatives and antioxidants. These
ingredients may be dried, milled, blended,
compressed and granulated to achieve the
desired properties before they are
Pharmaceutical manufacturing
process for dosage form.
Pharmaceutical manufacturing
process for dosage form.
• Liquid suspensions and emulsions are
produced by colloid mills and homogenizers,
respectively. Creams and ointments are
prepared by blending or compounding active
ingredients with petrolatum, heavy greases or
emollients.
• Liquid solutions for oral or topical use do not
require sterilization, solutions to be
administered to the eyes (ophthalmic) must
be sterilized. Oral liquids are prepared by
Pharmaceutical manufacturing
process for dosage form.
• Parenteral liquids are injected by intradermal,
intramuscular or intravenous administration
into the body, sterilized by dry or moist heat
under high pressure with bacteria-retaining
filters.
• Blended and granulated materials are
produced in tablet, capsule form.
Pharmaceutical manufacturing
process for dosage form.
• Modern pharmaceutical manufacturing
facilities and process equipment are reducing
environmental, health and safety risks by
preventing pollution and improving the
containment of hazards. Worker health and
safety and quality control objectives are
achieved by improving the isolation,
containment and cleanliness of
pharmaceutical facilities and process
equipment.
Pharmaceutical safety hazards to
workers.
• To prevent worker exposures to hazardous
substances and pharmaceutical products is
highly compatible with the concurrent need to
prevent workers from accidentally
contaminating raw materials and finished
products. Safe work procedures and good
manufFire and explosion prevention and
protection; process containment of hazardous
substances, machine hazards and high noise
levels, dilution.
Pharmaceutical safety hazards to
workers.
and local exhaust ventilation (LEV); use of
respirators (e.g., dust and organic vapour masks
and, in some cases, powered air-purifying
respirators or air-supplied masks and suits) and
personal protective equipment (PPE);and worker
training on workplace hazards and safe work
practices are workplace control measures
applicable during all of the various
pharmaceutical manufacturing Operation.
Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• Regarding issue of noise: Engineering methods
reduce sound levels by modifying, enclosing
and dampening noise sources. Employee
rotation and use of hearing-protective devices
(e.g., ear muffs and plugs) reduce workers’
exposure to high noise levels. Comprehensive
hearing conservation programmes identify
noise sources, reduce workplace sound levels,
and train workers on the hazards of noise
exposure and proper use of hearing-protective
devices.
Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• Noise monitoring and medical surveillance
(i.e., audiometry) assess worker exposures to
noise and their resulting loss of hearing. This
helps to identify noise problems and evaluate
the adequacy of corrective measures.
Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• As with the strong position compared to
others industries, the pharmaceutical industry
has resources, networks and expertise and has
a responsibility driving positive social change .
Though many companies in the
pharmaceutical sector are already doing
amazing work in helping to tackle complicated
and difficult issues. There are three key ways
in which pharma businesses can lead in
driving social change.
Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• To increase access to healthcare, pharma has
an obvious advantage compared to other
industries for social changes , pharma
business outputs are all designed to improve
and save lives. Pharna research and the
prepared life saving developing medicines
creations are paramount to the well-being of
society, playing a critical role in health care
that prevent, alleviate and cure diseases.
Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• To acquire adequate medicine remains a
crucial issue for many people across the globe,
facing barriers to get the proper needy urgent
healthcare and the situation can mean those
in rural areas, who face extreme poverty, are
left without adequate healthcare facilities.In
such cases pharmaceutical industry is
producing pharma businesses that can offer
their insights and expertise to NGOs to help
tackle global healthcare challenges.
Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• The industry has the potential to drive social
change in our society to review industrial
processes, utilise pharmaceutical industrial
networks and identify areas where industry
can contribute and give back to society.
Produced products are fundamental in the
treatment offered to patients.
Conclusion.
• Health is a universal right. To overcome
barriers for health facilities must be cured for
classes of people around the world. If the
most needy people have no access, then
vision of pharmaceutical companies to
improve global health will fall short by making
advanced progress to become part of a bigger
network sharing the same vision, and by
learning from each other's and foster
scientific advances.
Conclusion.
• Through charitable giving programmes
pharmaceutical industry can effectively tackle
complex issues and strengthen the support to
local communities in areas where
improvements are urgently needed.There is
necessity to use the power to take an active
role in improving the healthcare issues faced
by millions of people all over the world.
References.
• Hardman, JA Gilman and L Limbird. 1996.
Goodman and Gilman’s The Pharmacologic
Basis of Therapeutics. New York: McGraw Hill
Co.
• International Labour Organization (ILO). 1983.
Encyclopaedia of Occupational Health and
Safety, 3rd edition. Geneva. ILO.
• Spilker, B. 1994. Multinational Pharmaceutical
Companies: Principles and Practices, 2nd
edition. New York: Raven Press.
References.
• Reynolds, J. 1989. Martindale’s: The Extra
Pharmacopoeias, 29th Edition. London:
Pharmaceutical Press.
• National Research Council. 1981. Prudent
Practices for Handling Hazardous Chemicals in
Laboratories. Washington, DC: National
Academy Press.
• Gennaro, A. 1990. Remington’s
Pharmaceutical Sciences, 18th edition. Easton,
PA: Mack Publishing Company.
• Thank you.

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Social impact of pharmaceutical industry.

  • 1. Social impact of The Pharmaceutical Industry ensuring health in social and community development.Presented by Miss Sudipta Roy Designation: Assistant Professor Email: sudiptaroy89@gmail.com Place: Department of pharmaceutics Northern Institute of Pharmacy and
  • 2. Contents. • Aim and objective. • Abstract. • Introduction • Pharmaceutical products and it's role. • Pharmaceutical agents. • Pharmaceutical unit operation. • Pharmaceutical manufacturing process for bulk drug. • Pharmaceutical manufacturing process for
  • 3. Contents. • Pharmaceutical safety hazards to workers. • Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • Conclusion. • References.
  • 4. Aim and objective. • To ensure healthy human life as well as environmental sustainability for social and community development.
  • 5. Abstract. • Health is a critical challenge for society on basis of economic asset of people. Pharmaceutical industries and it's manufacturing products have been impacting health related issues for social and community development in major issues of reducing child and maternal mortality, slowing the spread of HIV/AIDS, malaria, tuberculosis, malnutrition of children promoting gender equality and empowerment.
  • 6. Abstract. • Here in this poster presentation, the fascinating role with its different manufacturing process for different types of dosage form of the pharmaceutical industry have been presenting for development of social care.
  • 7. Introduction. • There is important difference between developed and developing countries according to their needs for pharmaceutical substances. Malnutrition and infectious diseases are major cause of developing countries where nutritional supplements, vitamins and anti- infective drugs are most needed.
  • 8. Introduction. The diseases related to ageing are primary health concerns in developed countries and some specific diseases associated with cardiovascular, central nervous system, gastrointestinal, anti-infective, diabetes and chemotherapy drugs are mostly required.
  • 9. Introduction. • Drugs used for health of human and animal care is being prepared by same R&D activities and manufacturing processes. • Synthesized products having unique therapeutic benefits and mechanisms have been gone through their approval, distribution, marketing and sales process.
  • 10. Pharmaceutical products and it's role. • Biological products: Bacterial and viral vaccines, antigens, antitoxin, analogous products, serums, plasma and other blood derivatives. • Role: To protect therapeutically. • To treat humans or animals. Bulks: Active drug substance. Role: To manufacture dosage form for animal feeds, compound prescription medications.
  • 11. Pharmaceutical products and it's role. • Diagnostic agents: These substances may be inorganic chemicals, radioactive compounds. • Role: To assist diagnosis of diseases, disorders in human and animals. • To examine human organs like G. I. tract, circulatory system, liver etc.
  • 12. Pharmaceutical products and it's role. • Drugs: These substances are pharmacologically active and compounded with others materials. Role: To produce medicinal products. Ethical pharmaceuticals: These substances are biological, chemical agents. Role: To prevent, diagnosis, treat diseases and disorders in humans or animals.
  • 13. Pharmaceutical products and it's role. • Excipients: These are inert ingredients. • Role: To make combination with drug substances to create a dosage form products. • To help dosage form by affecting and controlling rate of absorption, dissolution, metabolism, distribution.
  • 14. Pharmaceutical products and its role. • Over the counter pharmaceuticals: These substances are drug products sold in retail store/pharmacy. Role: Without a prescription or the approval of a medical, pharmacy or veterinary professional, these drug products is being dispensed to a patient.
  • 15. Pharmaceutical agents. • Biological agents: The pharmaceutical industry uses biological agents, such as bacteria and viruses in many special applications like vaccine production, fermentation process, derivation of blood based products and biotechnology. • Chemical agents: These are divided into industrial chemicals and drug related substances that may be raw materials, intermediates or finished products.
  • 16. Pharmaceutical agents. • Industrial chemicals: These are used in researching and developing active drug substances and manufacturing bulk substances, finished pharmaceutical products. Organic and inorganic chemicals are raw materials, serving as reactants, reagents, catalyst and solvents. • Drug related substances: These are pharmacologically active products are divided into natural products and synthetic
  • 17. Pharmaceutical agents. • Source of natural products are plant and animal sources. Examples are antibiotics, steroid, peptide hormones, vitamins, enzymes, prostaglandins, pheromones. • Source of synthetic products are from microbiological and chemical technologies. • Pharmaceutical inactive ingredients: These are mixed with active drug substances providing desired physical and pharmacological properties in the dosage form products.
  • 18. • Diluting agents, ointment bases, pharmaceutical solvents and excipients.
  • 19. Pharmaceutical unit operations. • Weighing and dispensing: To weigh and dispense of solids and liquid is a very common activity through out pharma industry. • This operation must be performed in a partitioned work place area with good dilution, ventilation. • Weighing surfaces must be smooth and sealed to give proper cleaning. • To weigh and dispense highly toxic materials may require additional control measures. Eg.
  • 20. Pharmaceutical unit operation. • Charging and discharging solids and liquids: • These phenomenon are frequently happened through charged and discharged containers and process equipment in pharmaceutical manufacturing operation. • This operation may be performed manually by workers or by other methods such as gravity, mechanical/pneumatic transfer systems.
  • 21. Pharmaceutical unit operation. • Liquid separations: liquids are separated based upon their physical properties. • Eg. Density, solubility, miscibility. • Liquid separations are commonly performed during bulk chemical production, pharmaceutical manufacturing operations. • Hazardous liquids should be transferred, processed, separated in closed vessel and piping systems to reduce worker exposure to liquid spills and airborne vapours.
  • 22. Pharmaceutical unit operation. • Transferring liquids: • Liquids are frequently transferred between storage vessels, containers and process equipment during pharmaceutical manufacturing operations. • Sealed vessels and containers and piping system are highly desirable when transferring large volumes of liquids with precautions for inert gases pressurizing transfer lines/process equipment.
  • 23. Pharmaceutical unit operation. • Filtration: • Solids and liquids are separated during filtration operations. Filters have different designs and features. When open filters are used for hazardous materials, workers may be exposed to liquids, wet solids, vapours and aerosols during loading and unloading operations. Closed process equipment can be used to filter highly hazardous materials, reducing vapour emissions and preventing
  • 24. Pharmaceutical unit operation. • Compunding. • Solids and liquids are mixed in compounding operations to produce solutions, suspensions, syrups, ointments and pastes. Buffering agents, detergents and germicides that are neutralizing, cleaning and biocidal agents may be hazardous to workers. Eyewashes and safety showers reduce injuries, if workers accidentally contact corrosive or irritating substances.
  • 25. Pharmaceutical unit operation. • Granulation: • Dry and wet solids are granulated to change their physical properties. • Granulators have different designs and features with varying containment and control of mechanical hazards. • Enclosed granulators can be vented to air- control devices, reducing emissions of solvent vapours or dusts to the workplace and atmosphere.
  • 26. Pharmaceutical unit operation. • Material-handling concerns arise when loading and unloading granulators. Mechanical equipment (e.g., elevated platforms, lift tables and pallet jacks) assists workers to perform heavy manual tasks. Eyewashes and safety showers are needed, if workers accidentally contact solvents or irritating dusts.
  • 27. Pharmaceutical unit operation. • Drying: • Water- or solvent-wet solids are dried during many pharmaceutical manufacturing operations. Dryers have different designs and features with varying containment and control of vapours and dusts . Flammable solvent vapours and explosive airborne dusts may create flammable or explosive atmosphere;
  • 28. Pharmaceutical unit operation. • Milling: • Dry solids are milled to change their particle characteristics and produce free-flowing powders. Mills have different designs and features with varying containment and control of mechanical hazards and airborne dusts . Prior to milling materials, their physical properties and hazards should be reviewed or tested.
  • 29. Pharmaceutical unit operation. • Blending: • Dry solids are blended to produce homogeneous mixtures. Blenders have different designs and features with varying containment and control of mechanical hazards and airborne dusts . Worker exposures to drug substances, excipients and blends may occur when loading and unloading blending equipment.
  • 30. Pharmaceutical unit operation. • Compression: • Dry solids are compressed or slugged to compact them, changing their particle properties. Compression equipment has different designs and features with varying containment and control of mechanical hazards and airborne dusts Compression equipment may pose serious mechanical hazards if inadequately guarded. High noise levels may also be produced by compression
  • 31. Pharmaceutical unit operation. • Solid dosage form manufacturing: • Tablets and capsules are the most common oral dosage forms. Compressed or moulded tablets contain mixtures of drug substances and excipients. These tablets may be uncoated or coated with solvent mixtures or aqueous solutions. Capsules are soft or hard gelatin shells. Tablet presses , tablet-coating equipment and capsule-filling machines have different designs and features with varying
  • 32. Pharmaceutical unit operation. • Sterile manufacturing: • Sterile products are manufactured in pharmaceutical manufacturing plants with modular design , clean workplace and equipment surfaces, and high efficiency particulate air (HEPA) filtered ventilation systems.
  • 33. Pharmaceutical unit operation. • Cleaning and maintenance activities: • cleaning, repairing and maintaining equipment, utilities and workplaces. Although unique hazards may arise during non-routine tasks, recurring health and safety concerns are encountered. Workplace and equipment surfaces may be contaminated by hazardous materials and drug substances, requiring them to be cleaned before unprotected workers conduct servicing or maintenance work.
  • 34. Pharmaceutical unit operation. • Cleaning is performed by washing or wiping liquids and sweeping or vacuuming dusts. Dry sweeping and blowing solids with compressed air are not recommended, since they create high worker exposures to airborne dusts. Wet mopping and vacuuming reduce worker exposures to dusts during cleaning activities. Vacuum cleaners with HEPA filters may be needed when cleaning hazardous substances and high-potency drugs. Explosion-proof
  • 35. Pharmaceutical unit operation. • Packaging: • Finished dosage-form products may be packaged in many different types of containers (e.g., plastic or glass bottles, foil blister packs, pouches or sachets, tubes and sterile vials). The mechanical equipment fills, caps, labels, cartons and packs the finished products in shipping containers.
  • 36. Pharmaceutical unit operation. • Laboratory operations: • Lab workers may conduct scientific research to discover drug substances, develop manufacturing processes for bulk chemical and dosage-form products or analyze raw materials, intermediates and finished products. Clearly defined responsibilities, training and information, safe work practices and control measures and emergency response plans are important means for
  • 37. Pharmaceutical manufacturing process for bulk drug. • Pharmaceutical manufacturing process is basically of three major types of processes: fermentation, organic chemical synthesis, and biological and natural extraction. • Antibiotics, steroids and vitamins are produced by fermentation, whereas many new drug substances are produced by organic synthesis. Historically, most drug substances were derived from natural sources such as plants, animals, fungi and other organisms.
  • 39. Pharmaceutical manufacturing process for bulk drug. • Fermentation: • Fermentation is a biochemical process employing selected micro-organisms and microbiological technologies to produce a chemical product. Batch fermentation processes involve three basic steps: inoculum and seed preparation, fermentation, and product recovery or isolation.
  • 40. Pharmaceutical manufacturing process for bulk drug. • Fermentation:
  • 41. Pharmaceutical manufacturing process for bulk drug. • Chemical synthesis: • Chemical synthesis processes use organic and inorganic chemicals in batch operations to produce drug substances with unique physical and pharmacological properties. Typically, a series of chemical reactions are performed in multi-purpose reactors and the products are isolated by extraction, crystallization and filtration. The finished products are usually dried, milled and blended. Organic synthesis
  • 43. Pharmaceutical manufacturing process for bulk drug. • Biological and natural extraction: • Large volumes of natural materials, such as plant and animal matter, may be processed to extract substances which are pharmacologically active. In each step of the process, the volumes of materials are reduced by a series of batch processes, until the final drug product is obtained.
  • 44. Pharmaceutical manufacturing process for dosage form. • Drug substances are converted into dosage- form products before they are dispensed or administered to humans or animals. Active drug substances are mixed with pharmaceutical necessities, such as binders, fillers, flavouring and bulking agents, preservatives and antioxidants. These ingredients may be dried, milled, blended, compressed and granulated to achieve the desired properties before they are
  • 46. Pharmaceutical manufacturing process for dosage form. • Liquid suspensions and emulsions are produced by colloid mills and homogenizers, respectively. Creams and ointments are prepared by blending or compounding active ingredients with petrolatum, heavy greases or emollients. • Liquid solutions for oral or topical use do not require sterilization, solutions to be administered to the eyes (ophthalmic) must be sterilized. Oral liquids are prepared by
  • 47. Pharmaceutical manufacturing process for dosage form. • Parenteral liquids are injected by intradermal, intramuscular or intravenous administration into the body, sterilized by dry or moist heat under high pressure with bacteria-retaining filters. • Blended and granulated materials are produced in tablet, capsule form.
  • 48. Pharmaceutical manufacturing process for dosage form. • Modern pharmaceutical manufacturing facilities and process equipment are reducing environmental, health and safety risks by preventing pollution and improving the containment of hazards. Worker health and safety and quality control objectives are achieved by improving the isolation, containment and cleanliness of pharmaceutical facilities and process equipment.
  • 49. Pharmaceutical safety hazards to workers. • To prevent worker exposures to hazardous substances and pharmaceutical products is highly compatible with the concurrent need to prevent workers from accidentally contaminating raw materials and finished products. Safe work procedures and good manufFire and explosion prevention and protection; process containment of hazardous substances, machine hazards and high noise levels, dilution.
  • 50. Pharmaceutical safety hazards to workers. and local exhaust ventilation (LEV); use of respirators (e.g., dust and organic vapour masks and, in some cases, powered air-purifying respirators or air-supplied masks and suits) and personal protective equipment (PPE);and worker training on workplace hazards and safe work practices are workplace control measures applicable during all of the various pharmaceutical manufacturing Operation.
  • 51. Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • Regarding issue of noise: Engineering methods reduce sound levels by modifying, enclosing and dampening noise sources. Employee rotation and use of hearing-protective devices (e.g., ear muffs and plugs) reduce workers’ exposure to high noise levels. Comprehensive hearing conservation programmes identify noise sources, reduce workplace sound levels, and train workers on the hazards of noise exposure and proper use of hearing-protective devices.
  • 52. Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • Noise monitoring and medical surveillance (i.e., audiometry) assess worker exposures to noise and their resulting loss of hearing. This helps to identify noise problems and evaluate the adequacy of corrective measures.
  • 53. Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • As with the strong position compared to others industries, the pharmaceutical industry has resources, networks and expertise and has a responsibility driving positive social change . Though many companies in the pharmaceutical sector are already doing amazing work in helping to tackle complicated and difficult issues. There are three key ways in which pharma businesses can lead in driving social change.
  • 54. Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • To increase access to healthcare, pharma has an obvious advantage compared to other industries for social changes , pharma business outputs are all designed to improve and save lives. Pharna research and the prepared life saving developing medicines creations are paramount to the well-being of society, playing a critical role in health care that prevent, alleviate and cure diseases.
  • 55. Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • To acquire adequate medicine remains a crucial issue for many people across the globe, facing barriers to get the proper needy urgent healthcare and the situation can mean those in rural areas, who face extreme poverty, are left without adequate healthcare facilities.In such cases pharmaceutical industry is producing pharma businesses that can offer their insights and expertise to NGOs to help tackle global healthcare challenges.
  • 56. Role of Pharmaceutical industry collaboration in implementing development of social and community affairs. • The industry has the potential to drive social change in our society to review industrial processes, utilise pharmaceutical industrial networks and identify areas where industry can contribute and give back to society. Produced products are fundamental in the treatment offered to patients.
  • 57. Conclusion. • Health is a universal right. To overcome barriers for health facilities must be cured for classes of people around the world. If the most needy people have no access, then vision of pharmaceutical companies to improve global health will fall short by making advanced progress to become part of a bigger network sharing the same vision, and by learning from each other's and foster scientific advances.
  • 58. Conclusion. • Through charitable giving programmes pharmaceutical industry can effectively tackle complex issues and strengthen the support to local communities in areas where improvements are urgently needed.There is necessity to use the power to take an active role in improving the healthcare issues faced by millions of people all over the world.
  • 59. References. • Hardman, JA Gilman and L Limbird. 1996. Goodman and Gilman’s The Pharmacologic Basis of Therapeutics. New York: McGraw Hill Co. • International Labour Organization (ILO). 1983. Encyclopaedia of Occupational Health and Safety, 3rd edition. Geneva. ILO. • Spilker, B. 1994. Multinational Pharmaceutical Companies: Principles and Practices, 2nd edition. New York: Raven Press.
  • 60. References. • Reynolds, J. 1989. Martindale’s: The Extra Pharmacopoeias, 29th Edition. London: Pharmaceutical Press. • National Research Council. 1981. Prudent Practices for Handling Hazardous Chemicals in Laboratories. Washington, DC: National Academy Press. • Gennaro, A. 1990. Remington’s Pharmaceutical Sciences, 18th edition. Easton, PA: Mack Publishing Company.