Extended Service Program
The Extended Services Program (ESP) presents a worry-free solution for adhering to USP797 standards, transferring the responsibility from businesses to CTG. Each of the areas in this program relate to a necessary requirement of the standards. Through the ESP, ongoing support will be provided in key areas of USP797: Environmental, Training, Maintenance, and QA processes. All of these processes are automatically managed, scheduled, and recorded by CTG. Everything is included in one convenient .one-stop-shop. annual fee.
Environmental
CTG provides a comprehensive documented test plan for MIC certification. This test plan will automatically be executed semi-annually, and all records and data will be tracked. These procedures maintain compliance with USP797. Certification services can also be provided for your facilities. non-MIC solutions. These services would be in addition to the "one-stop-shop" annual fee and evaluated on a case-by-case basis.
Training
Both MIC operational and Aseptic Compounding training will be conducted annually on-site. In addition to the on-site training, a Train-the-Trainer program will be provided, which involves choosing 1-3 individuals to receive annual specialized training. Further, the most current operational documentation will be kept readily available. In response to the USP797 requirements for adequate evaluation of personnel participating in Aseptic Compounding, the ESP will provide Low/Medium Risk Level Media Fill Test Kits, these kits are optional and an additional charge, the ESP will have the capability to track, manage, and schedule all aspects of the Media Fill test.
Maintenance
USP797 calls for the Isolator to be supported by procedures for Operation, Maintenance, and Monitoring and Control. In addition to providing certification services on a semi-annual basis the ESP will also provide a regularly scheduled service "tune-up" call on an annual basis. This annual "tune-up" is a comprehensive inspection of the MIC system by one of our highly trained service technicians. The ESP further supplies continuous updates of all operating manuals, training documentation, certification test plans and other relevant documentation. The Extended Warranty Program is also included in the ESP.
QA Process
The ESP establishes a comprehensive systems solution that will play a vital role in the management of data, records, and processes in relation to maintaining USP797 compliance. This system provides the necessary data for supporting any internal QA/Audit Plan. (Real time client access to the ESP System is expected to be available in mid-2006)
If you have questions and would like to speak to a Extended Services representative, please call Containment Technologies Group at 317-713-8216.
