Personnel who are supervising or performing drug manufacturing or control can be a potential source of microbiological contamination and a vector for other contaminants.
The main reasons for contamination from the personnel include:
- Lack of training
- Direct contact between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product
- Inadequate personnel cleanliness
- Access of unauthorized personnel into production, storage, and product control areas
- Inadequate gowning and personnel protective equipment
- Malpractices like eating food, drinking beverages, or using tobacco in the storage and processing areas
People
People have a unique microenvironment that surround their bodies. The human body is home to billions of microorganisms.
They are found on skin surfaces, intestinal tract, in the mouth, nose, and other body openings.
If we do not utilize good aseptic technique and form good habits, the product can become contaminated.
Just the presence of people in a manufacturing area poses risks to parenteral products.