As active pharmaceutical ingredients (API) become more potent, the need for the validation of engineering controls and containment devices becomes imperative. Containment validation, also known as SMEPAC testing, is a critical component of any potent compound safety program. Containment validation can be performed using a variety of methods, however, the most common method is to mimic the actual process using a substitute or surrogate compounds. Affygility Solutions has significant experience in containment evaluation of powders weighing enclosures, glove boxes, hard and flexible containment as well as other types of engineering controls. Contact us today to obtain a quote. Our EHS professionals can save you time and money.

Preventing Occupational Exposure to Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients (APIs) with occupational exposure limits (OELs) less than 10 microgram/cubic meter as an 8-hour TWA are typically considered to be potent compounds. Prevention of occupational exposure to these compounds must rely upon effective engineering controls such as powders weighing enclosures, glove boxes, hard and flexible containment, down draft booths, and local exhaust ventilation.

Despite significant expenditure and effort on the installation of these controls, many of these controls fail to achieve the desired results. The cause of this failure varies, but in many cases it is due to inadequate procedures and training to ensure that the equipment is used as intended. Containment validation monitoring is an invaluable tool in not only determining proper equipment installation, but also in identifying weaknesses in administrative procedures.