Services Freeze-drying support laboratory 21 CFR Part 11 Compliant Control System based on PLC and user friendly SCADA System TELSTAR understands that precise control and reproducible results are paramount for efficient production. Moreover, loss of product can represent substantial value. For this reason, a Programmable Logic Controller (PLC), with proven reliability, is the process controlling device. The Supervisory Control and Data Acquisition (SCADA) system, integrates with the equipment PLC to provide user-friendly control and maximize process and operational safety. Software development and engineering practices follow current Good Automated Manufacturing Practices (cGAMP). The core application is 21 CFR Part 11 compliant. The emergence of biotechnology and the resulting production of protein-based therapeutic agents have increased the importance of freeze-drying process technology. This technology offers significant advantages such as: • Dosage form stabilisation • Accurate dosage vial filling • Rapid dissolution of the freeze-dried product • Sterility of the manufacturing process A fully equipped freeze-drying support laboratory is available for TELSTAR customers to determine the thermal properties of the product or to develop optimised freezedrying cycles. Freeze-drying fundamental training programs are also available. Preventive Maintenance Programs Routine Maintenance is an integral part of TELSTAR’s cGMP approach. All maintenance is properly documented to provide support during corporate audits and regulatory inspections. A preventive maintenance program will assure compliance and continuity of validated equipment status, maintain equipment reliability, minimise downtime and extend the equipment life-span. GMP Configurable Freeze-Dryer Series Validation support Engineering and manufacturing practices follow ISO 9001:2000 quality standards and the cGAMP (Good Automated Manufacturing Practices) guidelines. Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) testing and comprehensive documentation are standard TELSTAR practices. The aim is to make on site validation faster, easier and more efficient. Calibration services The SCADA provides multitasking operation in a WindowsTM environment. Single or multiple unit operations, including supervisory control and data acquisition functions are performed through one operator workstation. Keyboard strokes and mouse point and click actions make operator interaction simple and user-friendly. The suite of tools available includes: • Password: There are three access levels, identified as: Operator, Technical Management and Maintenance. Other access levels can be defined. • Recipes: Recipes include a set of cycle parameters such as temperature, vacuum, pressure and time variables for each process segment. • Cycle start: Prior to start a batch, a profile of the cycle can be selected for review and approval. • History: The historical data from a batch can be viewed and printed. • Diagrams: Equipment operation can be monitored through a variety of schematic diagrams. • Graphs: Process and control variable data and graphs can be selected and viewed. • Cycle control: The system provides for viewing cycle parameters on a real time basis. • Alarms: The system archives and displays a chronological list of events and alarms showing the state of each. • Batch report: A complete report of all the variables of a batch is produced. Calibration must fulfil both maintenance and compliance requirements. TELSTAR can develop a comprehensive program to gain direction for classifying instruments and setting appropriate limits to ensure product quality and avoid unnecessary deviation investigations. TELSTAR can provide calibration procedures and perform calibration of instruments using highly qualified technicians and fully traceable primary instruments. Training services A wide range of training programs are provided for machine operators, electrical and mechanical engineers, maintenance engineers and supervisory personnel. The programs are designed not only to improve the participants’ overall understanding of the production equipment, but also to enhance their confidence and performance levels to provide a beneficial return for the business. Upgrades & refurbishment TELSTAR’s Customer Service organization provides a wide range of refurbishing services: popular examples being control system upgrades, refrigeration and vacuum system improvements and retrofit of filter integrity testing. 01 312 0210 I Telstar reserves the right to improvements and specifications changes without notice. Far East No. 30 Jin Wen Road, Zhu Qiao Airport Ind. Zone, Nanhui District 201323 Shanghai (China) T +86 21 58 093 731 F +86 21 58 092 857

GMP Standard Freeze-Drying Solutions Lyonomic Series Perfecting the invented Competition in today’s global pharmaceutical and related industries has reached unprecedented levels and TELSTAR has launched the Lyonomic Series of freezedryers for those companies searching for ways to increase competitive edge. Lyonomic Series are state of the art freeze-drying systems, designed and engineered modularly to provide a comprehensive range of standard models and in-factory options. Lyonomic Series constitute a well-proven standard solution and provide the right balance between specification, quality,...

Services Freeze-drying support laboratory 21 CFR Part 11 Compliant Control System based on PLC and user friendly SCADA System TELSTAR understands that precise control and reproducible results are paramount for efficient production. Moreover, loss of product can represent substantial value. For this reason, a Programmable Logic Controller (PLC), with proven reliability, is the process controlling device. The Supervisory Control and Data Acquisition (SCADA) system, integrates with the equipment PLC to provide user-friendly control and maximize process and operational safety. Software development...