Interphex

L.B. Bohle, a manufacturer and supplier of processing solutions for pharmaceutical solids, will showcase a first-of-its-kind truly continuous granulator and dryer at INTERPHEX in New York City, April 1-3, at Booth 1519A. The company will offer technical overviews of its QbCon®1, a three-in-one module providing continuous raw material dosing, twin-screw wet granulation and drying in one compact, mobile machine. The machine’s continuous drying process is designed to guarantee flow from raw material to dried granulation in a closed, truly continuous operation for improved product quality, increased flexibility and enhanced operator safety.

The QbCon®1 can handle throughputs from 0.5-2.5 kilograms per hour (up to 5 kg per hour for certain products), making it suitable for research and development phases involving exceedingly small quantities of active pharmaceutical ingredients; at the same time, the versatile module affords efficient scale-up to commercial-level batches. QbCon®1 configurations for high-containment applications up to OEB 5 also are available.

Drying capabilities in pharmaceutical applications have historically been limited to semi- or quasi-continuous units operating on a per-batch basis. L.B. Bohle’s QbCon®1 employs a novel filter cleaning technique that is designed to keep the filter surface for the exhaust air permanently clear. This allows the machine to exhibit the primary pharma sector quality requirements for continuous manufacturing, including:

Short residence times for granules in the dryer, with simultaneous narrow residence time distribution – i.e. “plug flow” with extremely low back-mixing of particles

Traceability of all excipients and active ingredients in a continuous process

Uniform, reproducible drying of all granule particles, regardless of varying sizes

Exhaust air filters with lengthy lifespans, substantially mitigating drying process interruptions or filter changes.

Operations for all three process stages are controlled via a single, integrated HMI system. Assembly and disassembly can be completed nearly tool-free in just 10 minutes, as can wash-in-place (WIP) cleaning with water or detergent solutions, according to the company. The QbCon®1 also can be outfitted for data acquisition systems, yielding detailed process insights for optimized performance.

Each of the QbCon®1’s three critical process parameters – dosing, granulation and drying – remain constant throughout processing runs, according to the company. This setup significantly minimizes the number of granules in the exhaust air filters due to the extremely low fluidization of granules in the dryer. This results in filters completely free of product residue during cleaning, according to the company.