What controls or protection do I need?

Here at Affygility Solutions we often get asked, "Based on the numerical occupational exposure limit (OEL), the occupational exposure band (OEB) or occupational health category, what kind of protection or controls do I need?" The answer is as follows:

Without having a lot more information and performing a site-specific risk assessment, this is a difficult question to answer. To adequately answer this question, we would need to know the following:

• What specific active pharmaceutical ingredients are you handling and what are their numerical OELs or OEB assignments?
• What is the scale (mg to kg) of each step in the process?
• What is the physical form (solution, dry powder, wet cake, etc.)?
• What is the unit operation?
• What is the duration of the activity (minutes to hours)?
• What is the frequency of the activity (once per day to once per year)?
• What are the existing engineering, administrative, and personal protective equipment controls?
• What is the relative energy imparted on the process (low, medium, high)?
• What are the results of any prior industrial hygiene air monitoring?

After we are equipped with these additional details, on a per fee basis, we typically can perform a risk assessment using our Affytrac risk assessment tool.