Potent Compounds

Every year, more and more products coming from Research & Development are classed as potent drugs¹. Micronizing potent compounds present unique challenges for product containment due to dust creation during manufacturing. Micron Technologies continues to be at the forefront of the industry offering a micronization solution for all products. In the last three years, Micron Technologies has made substantial investments in the Malvern and Dartford locations in order to develop engineering controls as the primary protection for worker exposure.

Containment (isolator or glove box) solutions are now fully operational.  Historically, micronization inside containment has been a challenging process due to the massive air flow going through the mill. In general, containment solutions have been developed only for small scale operations.  In conjunction with industry leading experts, Micron Technologies has developed a unique isolator system capable of micronizing large quantities of potent compounds using large size jet mills.   This makes the process cost effective for our clients.

In partnership with leading industrial hygienist consultants, these isolators have been qualified for occupational exposure levels down to microgram or nanogram levels. Several large pharmaceutical companies have approved them and commercial products are being micronized using these isolators.

Not only are we able to micronize compounds with air jet mills under full containment, but Micron Technologies has also developed containment solutions for several other types of milling equipment available in its facilities such as Multi-processors, pin mills, hammer mills, etc.

A 100% cleaning verification is in place for all milling equipment.

Given the risks and hazards associated with highly potent compounds, the safest way to micronize them is to let the experts at Micron Technologies do it for you.

 The definition of an HPAPI varies depending on the literature; however, APIs deemed to be potent may fall into the following categories (4):

1. A pharmacologically active ingredient or intermediate with biological activity at approximately 150 μg/kg of body weight or below in humans (therapeutic daily dose at or below 10 mg)
2. An active pharmaceutical ingredient or intermediate with an occupational exposure limit (OEL) at or below 10 μg/m³ of air as an 8-h time-weighted average
3. A pharmacologically active ingredient or intermediate with high selectivity (i.e., ability to bind to specific receptors or inhibit specific enzymes) and/or with the potential to cause cancer, mutations, developmental effects, or reproductive toxicity at low doses
4. Or, by default, a novel compound of unknown potency and toxicity.¹

¹ PharmTech.com, by Patricia Van Arnum, Examining High Potency API Manufacturing, July 2, 2009