The Pharmaceutical industry has always been a risk-based environment; the newly released ISPE OSD Baseline Guide has an entire chapter dedicated to risk management from both a quality and a safety standpoint. The following is a brief discussion of potential risks and how utilizing single-use containment devices, bags, and liners can greatly mitigate and eliminate contamination risks in the manufacturing environment.
The risks associated with highly potent, cytotoxic, and hormonal products can typically be broken into two major categories: personnel risk and product risk.
To read more go to http://www.pharmpro.com/blog/2017/03/single-use-containment-mitigate-contamination-risks