Phoenix DB-6 Diffusion Testing System

DB-6 labeled, diffusion cells, heating block, computer control

The Phoenix DB-6 (six-cell diffusion block) provides an ideal platform compliant with 21 CFR Part 11 for release-rate testing of six vertical diffusion cells at once using manual sampling methods. Controlled by an advanced computerized display, the DB-6 provides uniform and precise heating and stirring of six cells. The compact footprint of 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 with a stated accuracy of ± 1.0 °C, while actual performance is typically within ± 0.3 °C. With 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. 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

sequence showing rapid mixing
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. Any unmixed, high concentration of API dwelling directly under the membrane will slow the diffusion process, affecting test results. The Phoenix system resolves this issue through custom-designed mixer-inserts inside each cell, driven by powerful brushless motors. The combination of grooved mixers and strong magnetic drives prevents the formation of diffusion-rate barriers directly under the membrane, thereby reducing 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.

Computer Control

The Phoenix DB-6 is controlled by an advanced single-board computer built into the color touch screen display. The Linux-based operating system with its own SQL database provides outstanding memory and processing speed. Power and serial communications occur through a cable connecting the display to the DB-6 block. The tethered display can be hand-held or moved to any nearby location, while a magnetized back allows it to attach to the front or side of the DB-6. The highly durable resistive touch screen responds instantly and works with labs gloves on or off. The intuitive, user-friendly interface of the DB-6 replicates the familiar look and feel of Hanson’s proven line of Vision G2 instruments. During a test, an easy-to-read screen displays temperature, stirring speed, elapsed time, and time to next sample. As a sampling point approaches, the system provides an audible alert and a countdown.

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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.

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.

Supply Kit

Each Phoenix DB-6 instrument comes with start-up supplies including 14 evaporation caps, 14 stoppers, and one each of disposable syringe (20 mL), tweezers, dosage mixer, stainless steel lab spatula, bubble inspection mirror, and plastic o-ring tool.

Phoenix Diffusion Cells

The 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; no water-jacketing is required, allowing 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), simplifying the sampling process while reducing training and operating costs.

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