The pharmaceutical industry is primarily concerned with the research, design, development and manufacture of drugs and medications for human and animal health. From health supplements to breakthrough treatments for chronic and acute illnesses, from expensive one-off treatments to everyday household medications, the pharmaceutical industry develops and manufactures a wide range of products, and calls upon an extensive network of suppliers and distribution companies to do so.
Pharmaceutical businesses range from private concerns to state-run enterprises and multinational giants, and their sites can be found at diverse locations around the world. There is always demand for their products, but with the COVID-19 pandemic, the pharmaceutical industry has seen exponential growth and sustained growth seems likely to continue into the foreseeable future.
However, the race to produce vaccines and effective treatments for COVID-19 symptoms was not straightforward. Pharmaceutical businesses have faced major supply chain and logistical challenges lately, some of which are set to continue and will shape their strategies as their navigate the post-COVID ‘new normal’. Many pharmaceutical companies will probably decentralise their production models and move towards smaller plant with agile set-up in many countries, as well as advances like continuous manufacturing, in order to minimise disruption.
Pharmaceutical manufacturing involves multiple hazardous unit operations, from synthesis of active pharmaceutical ingredients (such as the API) to processing operations such as milling, blending, granulation and drying.
Typical processes and associated gas detection issues
Exposure to flammable chemicals and solvents is one of the commonest hazards in pharmaceutical manufacture, and the storage of combustible solids and flammable liquids also generates fire hazards. If uncontrolled, fire can rapidly spread to other parts of the facility and escalate to trigger even more serious, secondary accidents. Common industrial utilities, such as boilers or heat exchangers, also present a risk of explosion.
In addition to posing a risk of fire or explosion, solvents and APIs used in pharmaceutical production are generally highly toxic. Prolonged exposure to some APIs may cause chronic health effects, or even death. Solvents can irritate the eyes and respiratory tract, and/or cause damage to the liver, kidneys, heart, blood vessels, bone marrow and nervous system. Inhalation of some solvents may have a narcotic effect, causing fatigue, dizziness, unconsciousness, and even death.
In pharmaceutical settings, nitrogen is usually generated on site. When liquid nitrogen leaks, it will quickly expand and displace oxygen in the surrounding area – in a confined space, the consequently reduced oxygen level can be fatal. Because nitrogen is an inert gas, detection of oxygen deficiency is a better indication of risk than the detection of nitrogen alone.
In the pharmaceutical industry, cleanliness is critical at all stages and automated CIP is routinely carried out before or after a production run. Typical CIP involves running a cleaning agent (hot water, steam, ozone, chlorine or hydrogen peroxide) through the process equipment – tanks, piping and fittings – without disassembly. The cleaning agents generally include a strong oxidising agent and a highly effective disinfectant. In some cases, CIP may pose a gas hazard.
Pharmaceutical production sites and chemical research and development facilities can give off strong odours. With multiple APIs and compounds being synthesised and mixed, and so many processes taking place, it is perhaps unsurprising that the malodorous gases emitted can be unpleasant for plant employees and neighbouring communities. In most regions, an offensive odour is considered a nuisance and potentially detrimental to health.
All pharmaceutical products sold in the EU need to meet the strict safety and quality standards set by the European Medicines Agency, and those sold in the US must meet the regulations issued by the US Food and Drug Administration (FDA).
Good Manufacturing Practice (GMP) is a system that ensures products are consistently produced in accordance with stringent quality standards. It is designed to minimise those risks arising in pharmaceutical production that cannot be eliminated through testing the final product.
EU regulations require all pharmaceutical manufacturers to comply with EU GMP if they wish to supply products to countries within the EU. Manufacturers and importers are regularly inspected to check compliance with the EU GMPs, regardless of where the manufacturing plant is located. The frequency of inspection is based on a risk assessment, and in addition the local national competent authority must supply written confirmation that the manufacture of each batch of product conformed to GMP regulations. The EU legislation governing pharmaceutical products is compiled in the publication The Rules Governing Medicinal Products in the European Union.
In the US, the regulatory standard for pharmaceutical products is set out in the Current Good Manufacturing Practice (CGMP) regulations. The FDA inspects manufacturers worldwide for compliance with CGMP, and issues guidance for manufacturers in the Code of Federal Regulations, Current Good Manufacturing Practice for Finished Pharmaceuticals.
