Resolute DAP offers manufacturers a flexible solution for multi-use operations such as those found in contract drug manufacturing, where quick and safe maintenance between drug batches is essential
Column chromatography is a critical purification step in downstream processing of biopharmaceuticals.
However traditional systems require significant downtime and labor to disassemble components for routine maintenance, resulting in production bottlenecks.
Pall helps processors overcome this challenge with the new Resolute DAP column chromatography system, which features an innovative hydraulic lifting mechanism for automatic column disassembly.
This system significantly streamlines cleaning and improves operational safety, cutting routine maintenance time by as much as two-thirds.
The Resolute DAP system offers manufacturers a flexible solution for multi-use operations such as those found in contract drug manufacturing, where quick and safe maintenance between drug batch processing is essential.
To disassemble component parts following processing runs, traditional column chromatography systems require hoists, service frames and safety supports, which are costly, cumbersome and potentially dangerous.
The Resolute DAP system automates this process by providing user-friendly push-button controls to lift and lower column components to desired positions using hydraulic actuators mounted below the column base.
Once components have been disassembled, operators have easy access at floor level to both bottom and top bed supports and seals.
In addition to eliminating the need for bulky lifting equipment, operators no longer need to handle heavy column components, speeding up maintenance and reducing risk of worker injury or damage to column tubes, cells and seals.
The system also enhances clean room operations by removing contamination sources from overhead lifting equipment, reducing ceiling height requirements and operational footprints.
"The Resolute DAP system is an important part of a drug manufacturer's strategy to streamline downstream processing, while improving overall operator safety," says Paul O'Neil, director of chromatography technology at Pall.
"This innovation is particularly beneficial in multi-use column installations since it provides a new level of operational automation and flexibility." Cylinder sensors on the Resolute DAP system along with anti-skew detection and correction controls help optimize chromatography operations and ensure a robust and repeatable performance for each drug processing batch.
With hydraulically assisted positioning of the adjuster end cell, the Resolute DAP system offers precise, real-time feedback during column packing, giving operators improved control over resin packing rates, pressures and ultimate bed height.
The system's operational controls enable the use of the widest possible range of chromatography resins and packing methods.
This flexibility allows manufacturers to operate multiple processes using the same equipment with minimal downtime for changeovers.
Additionally, the Resolute DAP column is outfitted with Pall Euroflow's patented pack in place nozzle that is pneumatically actuated from a control unit to run packing and unpacking operations efficiently, safely and accurately.
The design ensures a uniform flow distribution regardless of column diameter, resulting in a truly linear scale-up of chromatography operations.
Safety supports and barriers are fully integrated to protect operators from hazardous moving components during maintenance modes, and additional devices and control features have been incorporated in the hydraulic controller to ensure safe operations.
The Resolute DAP column is available in column sizes ranging from 40cm in diameter (25 litres) up to 2m diameters (600 litres).
All materials of construction are suitable for use in pharmaceutical manufacturing processes subjected to FDA or other national regulatory authority approval.
