Services Preventive Maintenance Programs Routine maintenance is an integral part of TELSTAR’s cGMP approach. All maintenance activities are 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. 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 efficient. Customized GMP Freeze-Drying Solutions Calibration services 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 is 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. BR-LYOMEGA-EN-1301 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

21 CFR part 11 compliant control system based on PLC and user friendly SCADA Challenges made easy through expertise and innovation The main challenges in today’s generic and specialty drug and biotech markets are shortening time to market and increasing productivity while assuring quality and reducing costs. Freeze-drying is not a novel technology by any means and the pharmaceutical industry, influenced by safety and validation requirements has introduced policies that tend to restrict process improvements. The focus of the industry has been focused on repeatability of the same process, and knowledge...

Integrated and Customised Solutions for Pharmaceutical Production Isolation and containment solutions TELSTAR’s in house expertise and manufacturing capabilities in isolation technology solutions facilitates a perfect integration of systems for containment or aseptic applications. Bulk filling / off loading systems 1. Loading and unloading systems 2. 1. Bulk freeze-dried product vacuum unloading operation through isolator. Containment: < 1 µg/m3 Freeze-drying systems 2. Freeze-dryer containment isolator. Containment: 1 ng/m3 Isolation and containment solutions Freeze-drying development support...

Loading and unloading systems Freeze-drying systems The Lyogistics range of freeze-dryer loading/unloading solutions covers a complete range of vial and bulk applications from manual through semi-automatic to fully automatic systems to meet the requirements of each project. Technologies include the use of anthropomorphic robots for handling of trays, vacuum-based bulk powder unloading systems, tray-less ‘fixed’ row-by-row or ‘flexible’ shelf-by-shelf vehicle systems. TELSTAR offers design flexibility to address the requirements of each project. Customisation capabilities cover a wide range of...

Loading and unloading systems Freeze-drying systems The Lyogistics range of freeze-dryer loading/unloading solutions covers a complete range of vial and bulk applications from manual through semi-automatic to fully automatic systems to meet the requirements of each project. Technologies include the use of anthropomorphic robots for handling of trays, vacuum-based bulk powder unloading systems, tray-less ‘fixed’ row-by-row or ‘flexible’ shelf-by-shelf vehicle systems. TELSTAR offers design flexibility to address the requirements of each project. Customisation capabilities cover a wide range of...

Integrated and Customised Solutions for Pharmaceutical Production Isolation and containment solutions TELSTAR’s in house expertise and manufacturing capabilities in isolation technology solutions facilitates a perfect integration of systems for containment or aseptic applications. Bulk filling / off loading systems 1. Loading and unloading systems 2. 1. Bulk freeze-dried product vacuum unloading operation through isolator. Containment: < 1 µg/m3 Freeze-drying systems 2. Freeze-dryer containment isolator. Containment: 1 ng/m3 Isolation and containment solutions Freeze-drying development support...

21 CFR part 11 compliant control system based on PLC and user friendly SCADA Challenges made easy through expertise and innovation The main challenges in today’s generic and specialty drug and biotech markets are shortening time to market and increasing productivity while assuring quality and reducing costs. Freeze-drying is not a novel technology by any means and the pharmaceutical industry, influenced by safety and validation requirements has introduced policies that tend to restrict process improvements. The focus of the industry has been focused on repeatability of the same process, and knowledge...

Services Preventive Maintenance Programs Routine maintenance is an integral part of TELSTAR’s cGMP approach. All maintenance activities are 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. Validation support Engineering and manufacturing practices follow ISO 9001:2000 quality standards and the cGAMP (Good Automated Manufacturing Practices) guidelines. Design Qualification...