24.2k views
4 votes
KNOW: A professional certifier must assess the primary and secondary engineering controls every ______.

User Raymie
by
7.5k points

1 Answer

5 votes

Final answer:

A professional certifier must periodically assess primary and secondary engineering controls to maintain safety and compliance with industry regulations, often every six months as per standards like USP Chapter 797.

Step-by-step explanation:

In the context of engineering, specifically referring to environments like cleanrooms or areas where air and environmental quality must be controlled for the purposes of research, manufacturing, or other sensitive activities, a professional certifier must assess the primary and secondary engineering controls periodically to ensure compliance with relevant standards and regulations. The specific timeframe for these assessments can depend on the industry standards, government regulations, and the type of controls in place.

For instance, in pharmaceutical compounding, guidelines like those issued by the United States Pharmacopeia (USP) dictate that primary engineering controls (PECs) such as laminar airflow workbenches (LAFWs) and compounding aseptic isolators (CAIs), and secondary controls like cleanrooms, must be certified every six months to maintain compliance with standards like USP Chapter 797. It's crucial for these controls to have regular, professional evaluations to ensure the safety and efficacy of the operations conducted within these controlled environments.

User Nenad Radak
by
8.2k points