Jul 2020

Pharmaceutical Manufacturing

The pharmaceutical industry is an important component of health care systems around the world that provides a great variety of medicines for numerous health care needs. Both public and private organizations contribute to the effort to discover, develop, manufacture, and market medicines.

The two main types of pharmaceutical products are pharmaceuticals and biopharmaceuticals. Pharmaceuticals are made using various chemicals, other raw materials, solvents, and catalysts in a controlled chemical process. These are the typical products when one thinks of medicines such as pills, tablets, and capsules. A product such as aspirin is a typical example.

Biopharmaceuticals are products that are commonly made using a fermentation, an enzyme reaction, or a recombinant DNA process that are commonly referred to as biotechnology. A simple example is the brewing of beer which is the fermentation of a mixture of ingredients such as barley and yeast.

Biotechnology processes produce larger naturally occurring molecules such as proteins, genes and cells, and process them in a way that can be utilized by the body.

Pharmaceutical manufacturing is a complex process that basically consists of developing active ingredients with the subsequent industrial-scale creation of an active ingredient into a final pharmaceutical product. Pharmaceuticals take a variety of different dosage forms such as solid, semi-solid and liquid. Common solid forms include tablets and capsules. Common semi-solid forms include ointments and creams. Common liquid forms include gels, solutions, emulsions, suspensions, and injections.

Common pharmaceutical processes used in both pharmaceutical and biopharmaceutical production include the following:

  • Chemical reactions such as synthesis or biochemical reactions
  • Processes related to chemical production such as crystallization, centrifuging, filtration, and drying
  • Size reduction processes such as milling and sieving
  • Mixing and blending processes of active and incipient ingredients in equipment such as cone blenders.
  • Granulation processes of active and incipient ingredients in equipment such as fluid bed granulators
  • Production of tablets in tableting presses
  • Freeze drying of products
  • Sterilization of equipment and product
  • Filling and packaging of sterile and nonsterile products
  • Warehousing of finished product

There are a variety of hazards present in pharmaceutical processes and equipment that include the following:

  • Chemical reactions that could include exothermic reactions and distillations for example
  • Ignitable liquids
  • Combustible dusts
  • Hybrid mixtures of ignitable liquids and combustible dusts
  • Flammable gases
  • Combustible storage
  • Equipment hazards such as dust collectors, carbon bed absorbers and fume incinerators

The pharmaceutical industry is also unique due to the large variety of specialized and high value equipment as well as the high value of active ingredients and finished products.

NFPA, FM Global and other stakeholders have developed loss prevention standards and recommended practices for many of the hazards and risks associated with pharmaceutical manufacturing processes and equipment. Risk Logic engineers can use these standards and their years of property loss prevention experience to help ensure that your pharmaceutical manufacturing operations are properly protected against damage from fire, wind, hail, and other natural perils. Please contact us for additional information.

Additional Reading Resources

  • Pharmaceutical Manufacturing Handbook – Production and Processes – Gad Consulting Services
  • The Pharmaceutical Manufacturing Process – Steps, Tools and Considerations – Thomas Industry Update
  • FM Global Data Sheet 7-36 – Pharmaceutical Operations
  • FM Global Data Sheet 7-46 – Chemical Reactors and Reactions
  • FM Global Data Sheet 7-32 – Ignitable Liquid Operations
  • NFPA 30 – Flammable and Combustible Liquids Code
  • NFPA 654 – Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing, and Handling of Combustible Particulate Solids