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The Phoenix DB-6 (six-cell diffusion block) offers an ideal platform compliant with 21 CFR Part 11. It supports release-rate testing of six vertical diffusion cells at once using manual sampling methods. Moreover, controlled by an advanced computerized display, the DB-6 provides uniform and precise heating and stirring of six cells. Thanks to its compact footprint, the DB-6 economizes on lab bench space.
Rapid and Precise Heating
Heating of the receptor media comes from the DB-6 dry heat block, programmable from 25 °C to 45 °C. It has a stated accuracy of ± 1.0 °C, while actual performance is typically within ± 0.3 °C. Thanks to the dry heat approach, there is no longer any need for conventional water pumps, jacketed cells, and a network of tubing running into and out of each cell. As a result, heat-up is fast. Starting at room temperature, the DB-6 block and its six diffusion cells typically reach the desired set point in 30 minutes or less.
Powerful Mixing and Homogenization
An important advantage of the Phoenix DB-6 is the speed with which the receptor cell’s contents are homogenized.
A critical factor in diffusion cell testing for IVRT and IVPT applications is the uniformity of the receptor media. In particular, any unmixed, high concentration of API dwelling directly under the membrane will slow the diffusion process, affecting test results. However, the Phoenix system resolves this issue through custom-designed mixer-inserts inside each cell, driven by powerful brushless motors. Grooved mixers combined with strong magnetic drives prevent the formation of diffusion-rate barriers from forming directly under the membrane. This reduces variability of test results. Stirring speeds are programmable from 200 rpm to 900 rpm with an accuracy ± 10%.
Bubble Detection and Removal
An air bubble trapped beneath the membrane in a vertical diffusion cell can be a source of release rate variability. In the Phoenix system, bubble detection and removal is fast and easy. Bubbles are easily detected using a lighted mirror. When a bubble is found, the analyst simply lifts and tips the cell to move it out through the top of the sampling arm.
Phoenix Diffusion Cells
Le Phoenix™ Diffusion Cell provides improved ease of use, high durability, and greater versatility as compared to conventional hand-blown vertical diffusion cells. Phoenix cells operate on dry heat, eliminating the need for water-jacketing. This allows construction from heavy-duty borosilicate glass held to very tight dimensional tolerances. The extract-and-replace sampling through the large diameter opening in the sampling arm accommodates standard pipette tips (~300 μL). This simplifies the sampling process while reducing training and operating costs.
Phoenix DB-6 21 CFR Part 11 Compliance
Support for 21 CFR Part 11 compliance includes a self-calibrating speed control; built-in diagnostics with instant on-screen alert; auditable logs for events, errors, test reports, test history, and service; serial number tracking of eight different elements (six of each element); real-time clock; serial printer connection; security settings for up to 50 users or administrator profiles; inactivity timeouts; and incorrect login lockout.
Configurate your own system
Our partner Teledyne Hanson has an unique configurator, try it out here, or just contact us, to configurate your system with one of our specialists.
Transition to Automation
Phoenix DB-6 blocks are designed to reduce costs when scaling up operations and transitioning from manual sampling methods to automated sampling using the Phoenix RDS platform. Each DB-6 block can be installed onto the Phoenix RDS robotic sampling platform without modification.
