Aseptic API manufacturing Sieving Solution for Microspheres Increases Throughput

Source: Press release Russell Finex 1 min Reading Time

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An aseptic ultrasonic sieve has increased microsphere powder screening capacity in sterile API production from 1.5 kg/h to 10 kg/h. Designed for GMP-compliant powder handling in contained environments, the system also reduces operator intervention and product losses.

The Russell Compact Sieve MS400 is fitted with a side-mounted ultrasonic probe and is designed for sterile powder handling in contained environments.(Source:  Russell Finex)
The Russell Compact Sieve MS400 is fitted with a side-mounted ultrasonic probe and is designed for sterile powder handling in contained environments.
(Source: Russell Finex)

A pharmaceutical manufacturer producing more than 250 sterile active pharmaceutical ingredients (APIs), including peptide-based products such as Octreotide, has upgraded its powder screening process to increase throughput and improve handling efficiency.

The company manufactures microsphere powders used in advanced drug delivery systems. These spherical particles, typically ranging from 1 to 1,000 microns, require controlled and hygienic processing under aseptic conditions.

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Sieving at 71 Microns

Following initial processing, the manufacturer sieves the microsphere powders at 71 microns using an ultrasonic sifter within a controlled, sterile environment. The previously used system achieved a throughput of around 1.5 kg/hour.

To improve performance while maintaining GMP compliance and aseptic requirements, the manufacturer selected the Russell Compact Sieve MS400 by Russell Finex. The compact sieve is fitted with a side-mounted ultrasonic probe and is designed for sterile powder handling in contained environments.

Reduce Product Loss of High-Value APIs

According to the manufacturer, throughput increased from 1.5 kg/h to 10 kg/h after installation, corresponding to a productivity increase of more than 500 %. The company also reports a reduction in operator handling of 30–40 %, contributing to improved process safety and lower contamination risk. The gentle sieving process reduces product loss, an important consideration when processing high-value APIs.

The screening system reduces reliance on autoclaving, lowering steam and energy consumption, and is compliant with isolator VHP cleaning protocols. The externally mounted ultrasonic system eliminates the need for probe sterilization between batches, reducing downtime and simplifying validation processes.

(ID:50881052)

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