Fine Chemicals And Highly Potent Active Pharmaceutical Ingredients

Fine chemicals are complex, single, pure chemical substances, manufactured in limited quantities through multistep batch chemical or biotechnological procedures. They can be classified based on their added value into building blocks, advanced intermediates or active ingredients. Most of these fine chemicals are used as starting materials for specialty chemicals like pharmaceuticals, biopharmaceuticals, and even agrochemicals.

High Potency Active Pharmaceutical Ingredients (HPAPIs), are generally small molecules with known therapeutic activity. They are being regarded as Active Pharmaceutical Ingredients that has an occupational exposure limit at or below 10 micrograms per cubic meter of air. Because of their strength, HPAPI compounds are known for their ability to target diseased cells more accurately and selectively compared with the usual APIs. Also, they are believed to be more highly effective at smaller doses.

Engineering controls should be used as the primary source for containment and isolation of potent compounds. Although PPE is also used, it is secondary employee protection for exposure control. The category assigned to the compound defines proper handling procedures as follows:

Potent-compound handling systems should ideally incorporate five levels of cascading protection, the first two being the primary methods of product isolation as follows:

  1. Process isolation: closed-system glassware and reactors, α/β valves
  2. Containment equipment: glove-box isolators, ventilated laminar flow enclosures, rapid-transfer ports, local exhaust ventilation, closed-system cleaning via clean in place
  3. Facility design: air pressurization, high number of air changes, single-pass air, restricted access, airlocks, safe-change filters, misting showers
  4. PPE: Saranex coveralls and hoods, PAPR or supplied air, proper glove selection, chemical suits when needed for solvents and reagents
  5. Personnel: training, procedures and policies, education, health monitoring.