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Transcript
ATTENTION: EDITOR
FOR IMMEDIATE RELEASE
NEW WET MILL DRAMATICALLY IMPROVES API MILLING CAPABILITIES
Size Reduction or milling of APIs (Active Pharmaceutical Ingredients) is a key step in the drug
development process. When milling an API, the developer requires a tight particle size distribution that
ensures consistent drug substance and drug product quality. Traditionally, dry milling technologies such
as media mills and jet mills have been employed but have come under increased scrutiny due to yield
losses, costs associated with containment and at times, detrimental impact on physical properties such as
the creation of amorphous material and surface defects. Wet milling offers a solution to some of these
challenges; however, traditional rotor/stator technologies lower particle size limit is often a mean volume
(mV) particle size of 30µm. As a result, wet milling has typically been performed by piston homogenizers,
high pressure valve homogenizers and media mills which are restricted by low capacities, high energy
consumption, and frequent maintenance requirements.
To overcome these restrictions, Quadro has developed the Quadro® HV-Emulsifier. The Quadro® HV is
an inline emulsifier and wet mill in one, and offers more than fifty-five times (55x) the high shear energy of
conventional rotor-stator systems with precise process scaling from lab formulation, to pilot and
production processing. In independent tests across multiple compounds having a wide range of starting
particle sizes, morphologies and mechanical properties, the Quadro® HV produced 60% smaller particles
than other conventional wet mills. Several of the compounds tested were found to mill down to a mean
volume (mV) of 10-15µm, compared to 28-35µm with traditional wet mills.
Other pharmaceutical applications for the Quadro® HV-Emulsifier include the development of submicron
emulsions (high shear homogenizing with a droplet size = 0.2-1µm), drug suspensions (high shear wet
milling with a particle size = 1-10µm) and topical formulations & semi-solids (droplet/particle size = 0.43µm).
The HV-Series features three (3) different models ranging from 7.5 to 60 HP with capacities ranging from
1 l/min of up to 285 l/min. All models utilize energy optimized tooling that operates at very high tip speeds
up to 70m/s with the lowest power consumption in the industry. The HV is designed with a sanitary highspeed mechanical seal that eliminates potential trap areas around the rotor shaft for improved CIP/SIP
results and can be customized for easy integration.
For more information, please contact:
Quadro Engineering Corp.
Telephone: (519) 884-9660
Fax: (519) 884-0253
E-mail: [email protected]
Website: www.quadroliquids.com