Russell Finex boosts API microsphere sieving efficiency
A global pharmaceutical manufacturer producing high-value sterile active pharmaceutical ingredients (APIs), including peptide-based medicines
A leading pharmaceutical manufacturer produces over 250 high-value sterile active pharmaceutical ingredients (APIs), including complex peptide formulations such as Octreotide. These APIs form the critical components within medicines, delivering essential therapeutic benefits.
Using aseptic manufacturing processes, the company produces microsphere powders, tiny, spherical particles ranging from 1 to 1,000 microns. These particles are central to advanced drug delivery systems, requiring precise and hygienic handling throughout production.
Following initial processing, the manufacturer sieves the microsphere powders at 71 microns using an ultrasonic sifter within a sterile, controlled environment. However, the existing solution posed significant challenges. With a limited throughput of just 1.5 kg/hour, the system could not meet increasing market demand, restricting production scalability.
To overcome these limitations, the manufacturer explored alternative GMP-compliant and fully aseptic screening solutions. After consulting with Russell Finex specialists, they selected the Russell Compact Sieve® MS400 fitted with a side-mounted ultrasonic probe, designed specifically for sterile powder handling in contained environments.
Since installation, the manufacturer has achieved a productivity increase of over 500%, with throughput rising from 1.5 kg/hour to 10 kg/hour. Additionally, the advanced design has reduced operator handling by 30–40%, improving safety and minimizing contamination risks. The gentler sieving process has also reduced product loss, critical when handling high-value APIs.
Further operational benefits include reduced reliance on autoclaving, lowering energy and steam consumption, and improved compliance with isolator VHP cleaning protocols. The externally mounted ultrasonic system eliminates the need for probe sterilization between batches, saving valuable production time and simplifying validation processes.
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