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STRICTER QUALITY CONTROL IN PHARMA SHIFTS THE BALANCE FROM SPIRAL TO OPPOSED JET MILLS
In the pharmaceutical industry, achieving the precise particle size and quality attributes of Active Pharmaceutical Ingredients (APIs) and excipients is paramount for drug efficacy and quality. Traditionally, spiral jet mills have been favored for their simplicity and ease of maintenance, yet they exhibit a notable drawback: sensitivity to variations in the feed particle size and synthesis stability, which can complicate the milling process and pose regulatory challenges. A new study introduces the opposed jet mill as a revolutionary solution, overcoming these limitations by employing gas pressure and a rotational speed-controlled internal classifier to ensure consistent particle size.
This paper presents findings from a comparative study on milling lactose, demonstrating that the opposed jet mill consistently maintains uniform particle sizes across different batches without needing adjustments to pre-validated process settings. These results indicate that opposed jet mills could provide a more dependable and efficient milling process for pharmaceutical companies, CMOs, and CDMOs, potentially leading to fewer production deviations, improved process stability, and simplified regulatory compliance. This shift could represent a significant advancement in pharmaceutical manufacturing technologies.
