Varian, Inc.
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Fiber Optic Testing
IO Fiber Optic UV System
Consumables

IO Fiber Optic UV System

Highlights

  • Complete automated on line UV solution
  • In-situ fiber optic probes - no liquid handling
  • Complete spectral profiles, even for IR formulations
  • Little time / labor between runs
  • IQ OQ PQ available for the system
  • Easy testing, validation and reporting

The Varian and C Technologies Team
Varian's UV spectroscopy and dissolution capabilities and C Technologies' specialization in fiber optic probe technology have been combined to create the IO fiber optic UV dissolution system. IO harnesses the power of the new fiber optic technology in a fully integrated and validated solution.

Complete Dissolution Solution
The IO system includes a computer, monitor, printer, Cary 50 Spectrophotometer with multiplexer, fiber optic probes and your choice of Varian dissolution tester. It is available in single- or dual-bath configurations.

Method-based System
The software allows you to run preprogrammed methods. A powerful sequencer automatically guides the operator through system setup and data acquisition. Once a run is started, operation is totally automated, even including printing a report at the end of the run.

Complete Dissolution Profile
Collect a complete UV spectrum from each vessel for every time point, as rapidly as every minute. You can specify multiple temporal regions in the run, each of which has a different data collection rate. This allows you to collect more data when the absorbance is changing quickly and to have fewer data points in the more stable parts of the dissolution profile.

Automatic Correction for Excipient Effects
Multiple software algorithms correct for any effects due to absorbance or scattering from excipients, undissolved capsules, surfactants, or anything else in the vessel other than the active.

Reporting Solution
A comprehensive report can be tailored for your specific reporting needs. Graphics showing percent dissolved versus time, and absorbance versus wavelength versus time can be included in a report. Also include in the report are both raw and corrected data, and a complete set of statistics. Finally, your dissolution reports can included your company logo or any bitmap you choose.
Audit trails are logged, providing information about how the data was collected and calculated.

GLP Compliance
GLP application is used to set up different privileges for the users in your laboratory and to comply with Good Laboratory Practice.

21 CFR Part 11 Compliance
We are committed to providing a system meeting this regulatory requirement. For an update on the current system, please check the Varian Web site at www.varianinc.com.

Optimized Probes
The IO fiber optic probes were specifically designed for dissolution. Their interchangeable tips allow using one probe for all your dosage strengths. Their thin cross-section minimizes hydrodynamic effects, which can be totally eliminated by using the system to automatically withdraw the probes when they are not taking measurements.

Cary 50 Spectrophotometer and Cassini Multiplexer
The Cary 50 Xenon lamp allows 80 data points per second.
The Xenon lamp flashes only when acquiring a data point, unlike a diode array which exposes the sample to the whole wavelength range with each reading, causing degradation of photosensitive samples.
The Cary 50 is unaffected by room light. It can be operated with the sample compartment opened or closed. The 12 probe Cassini multiplexer easily handles either 1 or 2 dissolution baths.

Software Components
The IO software is designed to run on Windows NT Workstations.
Software applications allow you to:

  • Create and store custom methods, which include equipment parameters
  • Perform routine wavelength scanning measurements
  • Scan the photometric values of samples over an entire wavelength range
  • Automatically correct for the effects of excipients on the data
  • Export data as an ASCII file for further data manipulation

System Qualification
We offer a complete qualification guide of the entire system (spectrophotometer, multiplexer, probes, dissolution tester and dissolution protocols). This guide is available to you as is the qualification service by one of our laboratory chemists. Our Laboratory Services Team can perform the qualification of the complete system for you. Call for details about our service capabilities.



IO Fiber Optic UV System


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