A contaminant is anything that could negatively affect the course of a process and/or the quality of a product. Cross contamination arises from the uncontrolled release of these contaminants.
People are the greatest source of contaminants, releasing anywhere from 40,000 - 100,000 skin cells per minute when motionless. Protecting from cross contamination is vital to ensure a safe product for the end user. It is critical to choose PPE that provides the highest level of inherent sterility but also the greatest chance of maintaining that cleanliness throughout the gowning process.
Protect the Worker
In the pharmaceutical industry, the greatest hazards arise through the formation of dusts (many pharmaceutical preparations include the use of dry solids), liquids (when transferring and dispensing dissolved substances), or aerosol (when dissolving dry solids). Engineering controls, administrative controls, and PPE (the Hierarchy of Risk Control) are all crucial to protect the personnel manufacturing, packaging, and inspecting these pharmaceuticals. Protective clothing worn in the pharmaceutical industry needs to prevent contamination of the product as well as protect personnel from potential hazards that arise during the manufacturing process.
Protect the End User
The purpose of the strict processes and protective standards in pharmaceuticals is to ensure no harm comes to the consumer. Contaminated pharmaceutical products are a danger to the end-user, who would not be able to determine from sight, smell, or touch that their product was contaminated or toxic. Contamination can lead to expensive shutdowns, increased spending, recalls, and potential loss of life. On average, pharmaceutical manufacturers spend approximately $3.1 million per year to remediate contamination events.