A Dedicated Interface
The Rx is a "dedicated interface" product exclusively designed for the automated detection, counting, and characterization of sub-micron particulate material in the pharmaceutical industry. Developed in conjunction with one of the world's leading pharmaceutical companies, it represents the only integrated solution for micro contamination quality control on the pharmaceutical production floor.
The ASPEX Rx control software incorporates sophisticated data mining techniques to capture terabytes of data relating to a variety of inorganic and organic foreign particles that could enter the production stream. Its first application was in the production of inhalant drugs, which demand unprecedented standards of product cleanliness. Today, the applications have extended to particle counting and characterization on:
- drug powders
- parenteral and oral products in general.
ASPEX Rx is ideally suited for automated, in-process quality control under production-floor conditions. The dedicated software and user interface, together with large specimen stage, ease of operation, self-service capabilities, and data storage, retrieval, and reporting features, make it a highly productive, cost-effective quality control tool, capable of analyzing a high volume of specimens on a 24/7 basis.
An Established Tool in the Analytical LaboratoryThe Aspex Rx can be routinely used for the following applications:
- QC investigation/Foreign Particle Detection/ Contamination Studies
- Particle Size Distribution Analysis
- Particle Counting
- Particle Elemental Composition
- Size, Morphology and Surface of Jet-Milled or Spray-Dried particles
- USP <788> Testing
- Surface Structure Analysis of Medical Devices
- Evaluation of Medical Devices, MDIs, DPIs, and Stents
- X-Ray Mapping of Tablets
Comply with the Changing Regulatory LandscapeASPEX Rx offers several key features that allow pharmaceutical industry customers to comply with the ever-changing regulatory landscape. The Audit & Authorization software package enables users to comply with 21 CFR Part 11 demands, and the ASPEX APLCM validates our product quality, which permits our customers to install ASPEX Rx in cGMP facilities. ASPEX Corporation FDA Compliance Features include:
"Permissions Editor" allows the system administrator to define users and/or groups by role-based access of up 20 operational features.
An audit trail file is saved to a secure location.
AFA configuration files are automatically protected via the audit trail file.
Records are printed directly to PDF files to support requisites for electronic signatures.
Deal with a Single VendorASPEX Rx eliminates the need to deal with multiple vendors, as well as the costs and complexities of attempting to integrate separate automation control software, imaging, and elemental analysis technologies.