Question

Explain the different sources of contaminations in sterile products, write in details about the Air quality in parenteral production areas.

Answer 1

Hloooooo.......

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, and

Malpractices like eating food, drinking beverages, or using tobacco in the storage and processing areas

thnxx for tgis questions hope this is usefull.....