Pharmaceutical companies around the world have the mandate to produce medicine that protects, saves and even cures illnesses of billions of people around the world.
It is not an easy process to come up with the array of drugs that are available in the pharmacies. It is a risky procedure that entails utmost safety in every process throughout the value chain.
API production and manufacturing is such a delicate production process that needs very high standards of safety. Controls need to be set to ensure that the working environment is safe to ensure the employees, visitors, contractors and the infrastructure are safe.
The manufacture of synthetic API production involves hazards like chemicals, fire, hazardous wastes, blast and poisonous emissions which need to be controlled.
Some of the significant safety hazards that occur in a lab include the following:
- a) Chemical hazards
- b) Thermal hazards
- c) Fire and explosions
- d) Process safety
The complexity in the exposure of chemicals during the manufacturing process is high. Inhalation of Volatile Organic Compounds from extraction, isolation and recovery activities are among the most common types of chemicals routes of exposure.
Personal protective equipment like gloves, masks, alarms and gas detection systems is paramount in an API production working environment. Other systems that are in use in current facilities include HVAC (Heating Ventilation and Air Conditioning) equipment, pumping, pressure and vacuum, systems are also used to control the discharge of emissions to the staff.
Fire and EXPLOSION
Pyrophoric reagents like n-Butyl lithium, metallic hydrides like potassium hydride are sued in the API production. These reagents are reactive when they are exposed to moisture and oxygen. Protecting them from exposure to air so as to avoid ignition is a priority in any API manufacturing facility.
Programmes that ensure process safety by explaining the chemical reactions, use of toxic materials and reaction processes should be positioned in strategic places and trained to the staff at regular intervals to create safety awareness.