Micronization For Potent Compounds
Every year, more and more products coming from research & development are classed as potent drugs. Micronizing potent compounds present unique challenges for product containment due to dust creation during manufacturing. Catalent Micron Technologies continues to be at the forefront of the industry offering a micronization solution for all products.
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, the team 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 hygiene 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 we have 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 Catalent Micron Technologies do it for you.
Learn more about Catalent’s long history of expertise in handling high potent molecules includes over more than 300 Category 3 & 4 compounds across 12 sites in the global Catalent network, including hormones and cytotoxics by viewing our overall capabilities here.