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5 Tools to Control Worker Exposure to Active Pharmaceutical Ingredients

November 16, 2016

Exposure to active pharmaceutical ingredients (APIs) presents health and safety risks for pharma company employees. Drugs are, after all, substances designed to have a specific effect on the human body.

In recent years, as pharma companies tackle difficult diseases such as new cancers, we’ve seen drugs become more complex and their APIs more toxic. That means the potential effects of worker exposure are amplified.

Here are 5 tools to control worker exposure to APIs in your facility.

Local exhaust ventilation (LEV) systems

The purpose of a LEV is to collect dust at its point of origin before it enters breathable air space. Commonly used in pharma environments, the system is basically a vacuum cleaner installed on a piece of equipment encompassed by a dust shroud.

Cyclone separators

In areas where dust is not immediately evacuated, use smaller equipment such as a cyclone separator to prevent dust dispersion into the main area of the plant.

Vacuums with HEPA or ULPA filters

If using a vacuum, make sure that it has the proper type and level of filtration. The goal is not just to capture the dust, but to keep it contained until it can be disposed of.

For cleanrooms, HEPA or ULPA filters are an absolute must:

  • A HEPA (high-efficiency particulate air) filter is a filter that is capable of capturing particles of 0.3 microns with 99.97% efficiency.
  • A ULPA (ultra-low particulate air) filter is a filter that is capable of capturing particles of 0.12 microns with 99.999% efficiency.

Ideally, your vacuum will have filters both upstream and downstream of the motor. The upstream filter protects the motor itself. Meanwhile, the downstream filter prevents the potentially harmful debris from being released back into the environment through the exhaust.

Complete dust containment systems

If you deal with high-potency APIs (HPAPIs), it’s time to bring in the big guns. That means a complete dust containment system. In this system, cyclone separation and HEPA filtration come together to ensure no toxic dust threatens your personnel, your product, or the environment.

Provide personal protective equipment (PPE), including respiratory protection

In many circumstances, proper PPE is required. It’s also frequently overlooked. Between October 2015 and September 2016, OSHA standard 1910.134: Respiratory Protection was the most-cited standard in the pharmaceutical and medicine manufacturing industry.

However, it’s also important not to rely too heavily on PPE. OSHA has found that respirators don’t always provide sufficient protection against toxic substances, often because workers use them incorrectly.

Have questions about dust containment in your pharmaceutical manufacturing facility? Our support team is here to help.

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