Drug Delivery System From Astech Projects
Tablet Pro is a tablet processing system which represents a major advancement in drug content analysis, Tablet Pro provides fully automatable stability analysis and uniformity testing to allow for higher throughput than any other system available. The system is designed for reliability and low operation costs over the long term through high specification robotics and an advanced filtration system which makes costly consumables a thing of the past.
The system operates on a user-friendly, fully 21 CFR Part 11 compliant software platform which provides high throughput with parallel processing capabilities. Tablet Pro is a versatile system which can provide automated sample analysis when integrated with Chromatographic Data Systems (CDS) and Liquid Chromatography (LC) systems as well as proprietary standalone tablet analysis systems to form a fully automated, comprehensive drug content analysis solution.
Injectables Testing Solutions
Drug delivery system production facilities working with prefilled syringes call for regular batch testing to ensure consistent quality and product content. Astech has a fully automated batch testing solution for prefilled syringes which is designed for high throughput. Automation modules for testing, analysis and preparation are available, using user defined product and method information.
Astech’s batch testing products include equipment such as the following to provide the right solution for your production or testing environment:
- Rack/plate handling arm
- Configurable storage area for new and used syringes, tubes, vials, etc.
- Syringe carousel/dispensing station
- Solvent dispensing station
- Vortex/mixing station
- Analysis instrument injection valve
Remote database server
These drug delivery system batch testing products are fully enclosed, with optional inclusion of environmental extraction or control capabilities. Systems are powered by Astech’s proven modular software architecture; allowing test methods to be made to your specifications, with full 21 CFR Part 11 compliance if needed. This software platform includes a control server and database schema along with an easy to use graphical user interface.
Operators load the batch testing system with prefilled syringes from the production line and select the proper testing protocol for each syringe from the user interface. The test is performed automatically and the results of the analysis of the drug delivery system sent to the database.
Astech Data Management Solutions for Drug Delivery System Testing
Testing drug delivery systems generates a great deal of data which must be compiled and stored. When testing is automated, an even greater volume of data is generated in a much shorter time. Astech understands data management and incorporates state of the art data management systems into our automated drug delivery solutions to store and organize data efficiently. Our database management systems ensure that your testing data can be easily searched to pull up the information needed for report generation. Astech’s data management solutions are designed to address the needs of scientists, researchers and QC professionals. We work with our customers to create systems which are suited to the testing requirements of the drug delivery system production environment.
The features offered by Astech’s data management systems include:
- ORACLE / SQL Server secure database applications
- ORACLE / SQL Server deployment for multi site operations
- Seamless integration into customer LIMS/ERMS
- ERES (21 CFR Part 11 compliance, where required)
- Cross platform interoperability with XML data generation
- User definable data report facilities
Verification and validation support for data entry integrity built into the user interface
A revolutionary line of products for testing Dose Content Uniformity of the Emitted Dose, Xelair is already in use by a wide range of companies in the pharmaceutical industry. Xelair has received the Queen’s Award for Enterprise and is rapidly becoming the industry standard.
Xelair includes a range of solutions for drug delivery system testing: semi-automated platforms, analyst workstations and fully automated systems designed for applications in high throughput environments. Xelair takes human variability out of the equation to produce consistently reliable and reproducible data while being easily adaptable to changing user requirements. Xelair’s core technology is harmonized across the entire product range for seamless migration from one product to another.
Xelair automation provides:
- Reduced variability
- Increased test data throughput
- Higher productivity
- Greatly reduced incidence of occupational health and safety issues including WR-ULD
- Contained handling of drug product to minimize the operator’s exposure
- Streamlined upgrade paths
- Harmonized testing throughout the Xelair range
Typical return on initial investment seen within a year of purchase
The Xelair range of automated solutions for drug delivery system testing includes:
Xelair 1 Series - Analyst workstations which automate individual stages in the dose content uniformity testing.
Xelair 3 Series - Semi-automated platforms for automated through-life testing of inhaler devices.
Xelair 5 Series - Fully automated systems which can operate unattended around the clock.
You'll also find other bespoke products and services from Astech which include their water quality testing and water analysis products, plus urine analysis and blood analysis and blood analyzer products.
Date added: 2011-08-06 10:20:48