The manufacturing of potent molecules is now an increasingly common phenomenon in the pharmaceutical industry worldwide. Accordingly, the need to process these products under containment is of utmost importance to ensure the safety of the personnel undertaking the powder processing operations.
Micronization of potent molecules under containment is, in all probability, one of the most complicated powder processing procedures compared to its predeceasing operations. Since jet mills operate under positive pressure and containment measures operate under negative pressure, the system requires a delicate balance to function effectively.
We believe it is critical to ensure that the micronization of potent molecules is done safely and effectively, making it more reliable and repeatable, thereby safeguarding the health and well-being of the involved operators in the manufacturing process. Based on our 30+ years of experience in micronization within the pharmaceutical industry, we have developed a solution that meets all these requirements.
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We supply our range of Midas Mikronizers with an appropriate negative-pressure rigid isolator for use with a wide range of potent molecules in the manufacture of cytotoxic APIs. Leveraging our decades-old experience in micronization has allowed us to design and manufacture an incredibly robust turnkey solution that can fit a wide range of needs in the pharmaceutical industry.
Right from designing the system keeping in mind the physical limitations of using equipment through glove ports to automating a majority of the processes to limit the stress put on operators, we have it all covered—all without compromising on the looks and ergonomics of our isolators.
Occupational Exposure Bands (OEBs) are safety measures that classify potent molecules to protect operators' health. The OEBs classify potent molecules into groups based on their Occupational Exposure Limit (OEL). The potent molecules with a lower OEL would fall into a higher OEB.
Our rigid isolators can safely handle potent molecules with OEB 5, for which the OEL falls < 0.1 μg/m3, ensuring maximum safety for the operator!
One of the most crucial aspects of integrating a process equipment into an isolator is to ensure that it is ergonomically efficient. Simply put, the operator should not struggle to use the equipment due to the limitations caused by the use of glove ports. Leveraging our vast experience in jet mills, we continuously improve the design to ensure that the product is micronized with ease, process losses are minimized and operator fatigue does not factor into the process. Significantly automating the system ensures that the process is less dependent on the operator, thereby reducing the chances of batch failures and/or containment issues.