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Automated Diffusion Tester
What is the Phoenix Flex?
The Phoenix Flex is an automated diffusion tester developed by Teledyne LABS for in vitro permeation testing (IVPT). It is designed for the analysis of skin flux in transdermal and topical drug delivery, supporting regulated workflows that require high precision and reproducibility.
The system enables fully automated IVPT processes, including filling, sampling, rinsing, refilling, washing, and bubble removal. It is operated through 21 CFR Part 11–compliant software and supports testing in accordance with USP <1724> and FDA requirements.
How does the Phoenix Flex automate IVPT workflows?
The Phoenix Flex automates key steps in diffusion cell testing to reduce manual handling and improve consistency. It supports both full media replacement and large aliquot replacement, which are required in many IVPT studies.
Key workflow capabilities include:
- Automated filling, collection, rinse, and refill cycles
- Automatic undosed (blank) sample collection before dosing
- Programmable sampling with up to 10 sampling points
- Flexible collection formats, including IVPT tubes and HPLC vials
- Staggered test starts to improve repeatability
The system can operate up to 24 diffusion cells simultaneously when two units are controlled via a single workstation.
What type of heating system does the Phoenix Flex use?
The Phoenix Flex uses a dry-heat diffusion cell system, eliminating the need for water circulation and reducing variability between cells. This design contributes to stable temperature control and improved reproducibility.
Key design elements include:
- Dry-heat blocks for temperature stability and consistency
- Real-time monitoring of receptor media temperature
- Infrared measurement of membrane temperature prior to dosing
- Automated tilting of cell blocks to remove air bubbles and prevent data distortion
- Cell holder design that maintains membrane integrity throughout testing
These features help ensure accurate drug permeation data, which is critical for studies such as bioequivalence of topical formulations.
How does the Phoenix Flex meet regulatory and data integrity requirements?
The Phoenix Flex is designed to meet regulatory and documentation requirements for IVPT studies.
Compliance and data integrity features include:
- 21 CFR Part 11–compliant control software
- Compliance with USP <1724>, OECD 428, and EMA guidelines for cutaneous products
- Recording of membrane integrity and skin integrity data
- Traceability through serialized components (cells, tops, and mixers)
- Automated reporting and printer connectivity
The Diffusion Master software provides a Windows-based interface to control, monitor, and document experiments, including the ability to run two systems in parallel.
