LOGAN PERMETRO 800HPLC 8-Position Dissolution-Permeation Coupled System
| Brand | LOGAN |
|---|---|
| Origin | USA |
| Model | PERMETRO 800HPLC |
| Instrument Type | Online Coupled Dissolution-Permeation System |
| Number of Dissolution Vessels | 8 |
| Temperature Range (Bath & Chamber) | 20–60°C |
| Temperature Accuracy | ±0.1°C |
| Rotation Speed Range | 25–250 rpm (±1 rpm) |
| Paddle Wobble | ≤0.5 mm |
| Basket Wobble | ≤1.0 mm |
| Water Bath Temperature Range | Ambient to 45°C |
| Water Bath Temperature Resolution | 0.1°C |
| Water Bath Volume | 18 L |
Overview
The LOGAN PERMETRO 800HPLC is an integrated, online dissolution-permeation testing platform engineered for pharmaceutical quality assessment and bioequivalence (BE) support studies. It combines a USP-compliant 8-vessel dissolution apparatus (UDT-818A-8), a physiologically relevant permeation module, and automated sample handling (AOIS 1200) into a single synchronized system. Unlike standalone dissolution testers, the PERMETRO 800HPLC enables real-time coupling of dissolution kinetics with membrane-based permeation profiling—mimicking key aspects of gastrointestinal absorption. This dual-parameter measurement supports mechanistic understanding of drug release *and* barrier crossing under controlled hydrodynamic and thermal conditions. The system operates on principles aligned with biorelevant dissolution modeling and is designed to generate data suitable for regulatory submissions under ICH Q5A(R2), Q5C, and FDA Guidance for Industry on Bioavailability and Bioequivalence Studies.
Key Features
- Eight independent USP Apparatus 1 (basket) and/or Apparatus 2 (paddle) dissolution stations, each with individual temperature and rotation control
- Integrated permeation chamber utilizing synthetic or biological membranes (e.g., Caco-2 monolayers, PAMPA, or porcine intestinal tissue) to emulate intestinal epithelial transport
- Dry-heating permeation module design—eliminates water immersion, enabling rapid disassembly, solvent-compatible cleaning, and reduced risk of microbial contamination
- Automated sequential sampling from both dissolution medium and permeate compartments at pre-programmed time points
- Direct interface capability with third-party HPLC systems (including Agilent, Waters, Shimadzu, and Thermo Fisher) via standard analog/digital I/O or Ethernet protocols
- Real-time synchronization of dissolution agitation, temperature ramping, permeation sampling, and HPLC injection timing through centralized control software
Sample Compatibility & Compliance
The PERMETRO 800HPLC accommodates solid oral dosage forms including immediate-release tablets, extended-release capsules, and multiparticulate systems. Membrane compatibility extends to synthetic lipid bilayers (PAMPA), immortalized cell lines (Caco-2, MDCK), and excised tissue preparations. All thermal and mechanical performance specifications meet or exceed USP , , and requirements. The system supports GLP-compliant operation when configured with audit-trail-enabled software and electronic signature modules compliant with FDA 21 CFR Part 11. Temperature uniformity across all eight vessels is validated per ASTM E2500-13; rotational stability is verified using laser vibrometry per ISO 17025-accredited procedures.
Software & Data Management
Control and data acquisition are managed via LOGAN’s proprietary Permeation Control Suite (PCS v4.x), a Windows-based application supporting method development, sequence programming, real-time monitoring, and raw data export in CSV, ASCII, and .xlsx formats. PCS includes built-in calculation engines for dissolution efficiency (DE%), similarity factor (f2), permeability coefficient (Papp), and cumulative mass transfer. All user actions—including method edits, calibration events, and sample injections—are logged with timestamps, operator IDs, and IP addresses. Audit trail reports are exportable in PDF/A format for regulatory review. Optional integration with LIMS platforms is available via HL7 or RESTful API.
Applications
- Comparative dissolution-permeation profiling of generic and reference listed drugs (RLDs) during ANDA development
- Predictive assessment of absorption-limited bioavailability for BCS Class II and IV compounds
- Excipient impact evaluation on both release kinetics and transmembrane flux
- Formulation optimization for modified-release products where permeation rate governs overall exposure
- Supporting waiver requests for in vivo BE studies under ICH M9 (Biopharmaceutics Classification System-based Biowaivers)
- Stability-indicating permeation assays to detect degradation-induced changes in membrane interaction
FAQ
Can the PERMETRO 800HPLC operate without an external HPLC?
Yes—the system supports UV/Vis spectrophotometric analysis via optional fiber-optic probes or fraction collector-based offline quantification.
Is the permeation module compatible with live cell cultures?
Yes, provided appropriate environmental controls (CO2, humidity, sterility) are maintained externally; the dry-heating architecture avoids condensation risks near culture inserts.
What validation documentation is supplied with the system?
Each unit ships with Factory Acceptance Test (FAT) report, IQ/OQ protocols, and a traceable calibration certificate for temperature, rotation, and volume delivery subsystems.
Does the software support multi-user role-based access control?
Yes—administrators can assign roles (e.g., analyst, reviewer, approver) with granular permissions for method editing, data deletion, and audit trail viewing.
How is temperature uniformity verified across all eight vessels?
Using NIST-traceable PT100 sensors and a certified thermal mapping procedure per USP Annex, performed annually or after major maintenance.
