As the popularity of high potency active pharmaceutical ingredients (HPAPIs) rapidly increases in new drug development, manufacturers are increasingly searching for ways to safely and efficiently process HPAPIs.
To protect operators and the environment from exposure to the cytotoxic properties of HPAPIs, manufacturing facilities that may have only previously processed non-potent APIs are now investing in specialised containment solutions.
High Containment Solutions for Milling HPAPIs
Although conical mills typically produce less dust than alternative forms of milling, there will still be some level of dust generation as a result of the high energy involved in particle size reduction. This needs to be managed responsibly to prevent operators and the environment from being exposed to dangerous airborne powders.
A fully contained milling process is required for the purposes of safety and cross contamination avoidance. The Hanningfield Uni-Mill can be designed to be a completely closed system, offering a number of ways to overcome the significant challenges of containing dust, including Container-to-Container Milling, In-Line Vacuum Transfer and Milling Inside an Isolator.
Container-to-Container Milling
This solution uses the principle of gravity to feed product through the mill. By positioning a bin above the mill, and another bin below the mill, product is released from the top IBC, milled, and then passes directly into the bottom IBC.
The integration of a split butterfly or high containment valve between the inlet and outlet of two process components creates a fully contained method of product transfer, with virtually zero exposure to either the operator or the process environment. These valves provide the most effective high integrity method of contained transfer.
In-Line Vacuum Transfer
Another option for achieving a completely closed system is to pneumatic or vacuum transfer the product through the mill, which uses contained pipework and hoppers to transfer the material (such as the Hanningfield Uni-Vac).
Closed loop vacuum transfer not only contains the dust, but also automates the process and minimises waste – helping customers make efficiency savings. Additionally, vacuum transfer through a mill reduces the operating temperature inside the milling chamber; a further benefit to improved processing.
This process ensures that from pick-up to discharge the system is fully enclosed; preventing the escape of dust and subsequently protecting both the operator and the environment.
Isolator Milling
An excellent solution for high containment milling is to use the mill inside an isolator / glove box. By creating a safe environment around the milling head, all excess material remains enclosed within the booth and ensures that the environment and operators are not exposed to any dust particles.
Hanningfield offers a ‘through the wall’ design for the Uni-Mill which enables the milling head to be contained within the glovebox, while the motor and controls are mounted externally. All cleaning operations are undertaken within the isolator by means of gloves or half-suit, reducing any risk of exposure for the operator and avoiding any transport to the cleaning room. The mill head can be removed from the rest of the body for cleaning simply by releasing a Tri-Clover.
Uni-Mill: Safe and Efficient HPAPI Milling
The Hanningfield Uni-Mill is perfect for high containment milling applications, providing a completely safe and high performance solution. All mills are compatible with a wide range of screen and impeller tooling, so they are able to achieve various final particle sizes and throughputs. The Uni-Mill is suitable for both dry and wet milling applications and can achieve size reduction down to approximately 150 microns (80 mesh).
Consistently achieving a narrow particle size distribution is vital in HPAPI milling as the particle size is a crucial parameter which affects drug properties such as bioavailability, solubility and stability. The Uni-Mill allows you to tightly control final particle sizes, reducing rejected off-specification powders and generating efficiency savings.
Operator safety is of upmost importance in all applications and the Uni-Mill enables HPAPIs to be completely contained, while limiting the explosion potential, and Operator Exposure Limits (OELs) to be controlled within the strict industry standards.
Our high quality conical mills, coupled with our expertise in milling applications, means that we are proficient in supplying high containment solutions to best suit your application. We work with you to understand your process and guide you through the options you have available to ensure a fully contained milling process.
Features and Benefits
> Stainless steel construction (with 316L contact parts)
> All seals FDA compliant (silicone, PTFE etc.)
> No metal-to-metal contact
> Easy-clean, GMP design (with optional features such as detachable millhead for autoclave or CIP/WIP)
> ATEX (ex-proof) versions available
> High throughput for maximum productivity
> Inline feed and discharge for higher capacity and ease of system integration (minimal stack-up height and no offset between inlet/outlet)
> Achieve various particle sizes on one machine, simply by changing screen and / or impeller
> Spacerless design with preset optimised ‘gap’ for milling
> Easy to operate
> Low heat, dust and noise generation for improved working environment
> Process scalability from lab to pilot to production
Learn More About the Uni-Mill >>>
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