Over the past several years, the pharmaceutical industry has introduced a new range of highly potent active pharmaceutical ingredients, or HPAPIs.
These HPAPIs allow drug manufacturers to create highly targeted drugs that work faster and at lower doses than traditional medicines. They are also extremely toxic.
There are several types of drugs associated with HPAPI applications, including but not limited to the following:
- Sex hormones: estrogen or testosterone
- Opiates: painkillers
- Antibiotics: penicillin
- Cytotoxic drugs: used to fight cancers
- Prostaglandins: used to fight tissue and muscle damage
Because exposure to these drugs can cause irreversible health effects, it’s essential that workers be protected from even the smallest exposure to them.
Every pharma company handling HPAPIs needs to establish an occupational exposure limit, or OEL. These are based on hazard classes called occupational exposure bands (OEBs). The table below shows the OEBs and their associated OELs, as well as the maximum amount of API exposure permitted per day.
|OEB||OEL (μg/m3)||API Content (mg/day)|
|1 – Nontoxic||1,000-5,000||> 200|
|2 – Practically nontoxic||100-1,000||10-100|
|3 – Slightly toxic||10-100||1-10|
|4 – Toxic||1-10||0.1-1|
|5 – Highly toxic||< 1||< 0.1|
|6 – Extremely toxic||< 0.2|
At OEBs 1 and 2, personal protective equipment (PPE) and in-house procedural controls are often sufficient for worker protection, depending on the manufacturing process. OEBs 3 to 6 are considered dangerous. These levels usually require the use of engineered controls, such as a dust containment unit.
Nilfisk recently launched a new dust containment system designed specifically for pharmaceutical manufacturing. This system protects workers from exposure to HPAPIs and protects the environment from risk of contamination, even during the maintenance of the containment system itself. The unit can be custom-engineered for use alongside any pharmaceutical manufacturing equipment, including tablet presses, capsule fillers, blistering machines, and so on.
For pharma manufacturers, a dust containment system can be a powerful weapon in the fight to keep environments safe, pure, and effective. Learn more about this new solution at INTERPHEX booth #2537.