Titration Pharma. Safe Titration Minimized Risk Reduced Efforts Successful Audits. Guaranteed Quality Safe Titration in the Pharmaceutical Industry

Transcription

1 Titration Pharma Safe Titration Minimized Risk Reduced Efforts Successful Audits Guaranteed Quality Safe Titration in the Pharmaceutical Industry

2 Safe Titration Titration without Surprises Minimize Risks Safe titration encompasses the entire life cycle of your investment The selection of the correct analysis instrument does not only encompass the knowledge of your current needs, but also your future requirements. Modular titration systems such as the Excellence Series offer solutions for the security of your investment. Safe titration begins long before daily titration in the laboratory: a need-oriented selection of titration systems, as well as a professional installation and training are the basis for titration without risk. Targeted maintenance and professional handling during everyday application are a guarantee for reproducible results. For all steps along the way, METTLER TOLEDO offers comprehensive support, so that you invest in the right place, with targeted efforts minimizing your risks. Well-informed users and regularly maintained titrators avoid measuring errors in the daily routine and thus expensive follow-up costs can be eliminated. The many years of METTLER TOLEDO know-how is at your disposal in the form of comprehensive literature and a technically trained sales staff. Beyond that, the users can refresh their knowledge for daily titration in the offered customer seminars. For regular maintenance METTLER TOLEDO offers tiered services, so that with optimized deployment many risks can be reduced. According to GLP/GMP regulations, each analytical instrument applied either in the production or in the quality control has to be qualified and maintained. Moreover, all these activities have to be documented. METTLER TOLEDO supports its customers in performing the qualifica- tion by providing the instrument qualification dedicated documentation and offering the qualification service. Professional training gives you in addition the required security and expertise in handling the titrator. Good Titration Practice TM

3 Select with Foresight Protecting your Investment Each user has his own Home screen Each user has different tasks and access rights. Nevertheless everyone would like to tackle his tasks, if possible, with a single key stroke. For this reason, the personalized Home Screen is the ultimate solution. Typical requirements of the pharmaceutical industry cover the areas: Regulatory compliance Productivity increase/cost reduction Data management Accuracy/reliability of results Qualification/audit preparation The Production Technician has just a few titration tasks. His screen shows one button for each. He cannot go wrong. Just One Click and his analysis is started! Guided by the highly optimized user interface, the Lab Manager can easily define all necessary settings. Many actions are just One Click away. The Lab Assistant has many different titration tasks. She can arrange all of them on her own home screen and start what is needed with just One Click. Only modern titrators are applicable, like those products of the Titration Excellence Series, which offer together with suitable product qualities combined with other products and services, the required total concept: Simplest operation (customizable for individual users) and measures for the safe use and monitoring of the assigned titration solutions, sensors and other resources. Upgradeable to highly automated systems for increased productivity. Expandable modules for keeping pace with future developments. Electronic data management with LabX according to the requirements from FDA 21 CFR Part 11. Documented equipment qualification (EQPac) for the titrators and system validation for the PC Software LabX. Supportive know-how from METTLER TOLEDO for the selection of the correct analysis method. Documented requirements secure the right choice In the EQPac from METTLER TOLEDO, the Design Qualification is an integral component and assures that the requirements are documented in the logbook of the equipment. Titration Excellence DL31/DL38 Manufacturer: METTLER TOLEDO Instrument type: Instrument internal number: Instrument serial number: EQPac Equipment Qualification Package Comprehensive assistance for the selection of the right titrator and the correct method Detailed product documentation, text books and comprehensive application databases as well as the technically trained sales staff of METTLER TOLEDO help you evaluate the right titrator for your needs. We pay particular attention to the specific requirements of the different users. Since the users can change over time, a future-oriented solution is always a concern for us.

4 One Click Titration Simple Efficient and Secure Tailored exactly to fit perfectly Successful companies take the most direct route to achieve their goals. This safeguards their leading position and enables them to offer their customers decisive advantages. The most direct route is characterized by simplicity, efficiency, and security The modular titration platform is a sound investment The modular design of the Titration Excellence line guarantees that you are optimally prepared for future changes. Even complex processes can be automated and started. Expandable at any time with intelligent accessories for automatic sample preparation, with the clever CoverUp lid handling device to avoid contamination and unpleasant odors, with a second tower to separate different determinations such as conductivity from ph measurement, with kits for COD or KF titrations, and so on the system grows with your requirements. Plug & Play Sensors kept under control The instruments in the Titration Excellence line automatically recognize Plug & Play Sensors. All relevant data is saved in the Sensor Chip and automatically transferred to the titrator ensuring the correct sensor is being used at all times. Intelligent burettes guarantee security Is the correct titrant in the burette? Is the concentration right? Has the titer expired? On which drive is it installed? The Titration Excellence system automatically verifies all these parameters when an analysis is started. Simply mount the burette and it does the work for you. Complete efficiency One Click Titration The Titration Excellence line ensures you get your results easily and quickly. The Short Cuts, which can be set up specifically for each user, are extremely helpful. Whether you want to calibrate electrodes, rinse burettes or start methods you can define a Short Cut for any operation you like and store it on your Home Screen. Maximum security through flexible Titration Excellence instruments are equipped with a comprehensive user management system that allows you to register each user and to set up a Home Screen for each user. Depending on who logs on to the titrator, the corresponding Short Cuts together with the other userdefined settings appear such as screen settings or the language the user requires. The Sensor Chip saves all relevant sensor data. The burette data is automatically read by the RFID sensor. Start your analyses directly using Short Cuts (from the Home Screen).Your titrator can simultaneously run up to eight different tasks. The LabX pro titration software provides all the tools Required for data management and storage according to FDA 21 CFR part 11 regulations such as password protected user login, digital signature for critical manipulations and recording of every action in the audit trail. LabX offers control charts and individual search filters, quick and comprehensive method development for all applicative challenges and complete traceability of your data. The integration of the titrators into a network could not be easier thanks to a direct Ethernet connection.

5 LabX Software Validation Correct Measurements from the Start Knowledge as a Tool Save costs increase expertise Professional start-up, qualification and complete documentation guarantee the adherence to your process requirements starting from first titration. Our specialists install the titrator, taking into consideration the regulations, environmental and process conditions, optimize user settings and the getting the best out of the titrator system. You profit from our experience and minimize risks from the beginning. Safe Handling Professional training gives you necessary security and expertise in handling the analyzer. You save time and can rely on the fact that the users and equipment are primed for their tasks. Titration Excellence DL31/DL38 Manufacturer: METTLER TOLEDO Instrument type: Instrument internal number: Instrument serial number: EQPac Equipment Qualification Package METTLER TOLEDO can help you to efficiently go through the LabX system validation by offering the following tools and services: Validation Service: Full on-site support of the LabX validation. Validation Manual I: Folder containing all information necessary for the qualification of METTLER TOLEDO as software supplier. Validation Manual II: Folder containing guidelines and all the necessary forms for the LabX system validation. Revalidation Service : Information package including new forms for the revalidation after a LabX upgrade/update. Equipment Qualification Professional start-up and qualification using the METTLER TOLEDO Equipment Qualification Package (EQPac) is the first important step for adherence to the process requirements. It is also the beginning of complete traceability without any gaps. Increased productivity and minimized risks from the start METTLER TOLEDO s qualification solutions for titrators take away the guess work when it comes down to ensuring quality and regulatory compliance. These services staged according to customer demands and covering either initial or entire equipment qualification are professional solutions and offer a myriad of benefits: No time wasted a quick installation and qualification allows you to immediately start working with the titrator. Increased productivity users receive product familiarization to ensure productive processes. Compliance limited risk of non-compliance during FDA audits and other quality management system assessments.

6 Innovative Services for Continuous Correct Titration Measurements Well Maintained Titrator to Guarantee Accurate Results Because we know that the most significant costs associated with a maintenance plan are often not considered, we have designed tailored service packages to best match your needs. Some of the hidden costs are downtime product nonconformance, or measurement inaccuracies. When selecting a service solution, the focus should be to minimize the total cost of ownership and increase the effectiveness of your manufacturing processes. Each measurement bears risks, which can impair the quality of your products. Avoid measuring errors in the daily routine through well-informed users and regular titrator maintenance. Promising Know-how transfer Use the many years of METTLER TOLEDO know-how, which is available to you in form of a comprehensive application database on the internet or as reference literature (see table). Or refresh your knowledge in daily titration in one of the offered customer seminars, where you also have the opportunity to exchange experience with others. For regular maintenance METTLER TOLEDO offers tiered services, so that with optimized deployment many risks can be reduced. Use the rich offer of customer seminars A well-trained staff can perform their tasks efficiently and master them successfully. We support you with different events and seminars, which we have been conducting successfully now for over ten years. Maintenance and calibration process Initial testing/calibration Function of titrator components such as stopcock, burette and electrode input are checked. Knowledge as a tool useful know-how provided to you by METTLER TOLEDO More than 400 ready-to-use titration applications on: Applications Brochure 14: Good Laboratory Practice in the Titration Lab ( ) Applications Brochure 16: Validation of Titration Methods ( ) Applications Brochure 15: Guidelines for Result Check, Method Validation and Instrument Certification ( ) Applications Brochure 25: Applications in the Pharmaceutical Industry ( ) Applications Brochure 8 + 9: Standardization of titrations ( , ) Cleaning and adjusting The instrument is disassembled and PC-boards, burette, stopcock drives and gears are cleaned and adjusted. Final testing/calibration Electrode voltage is checked along with stirrer, burette, tubing and RS232 output. Documentation The titrator service is recorded in the appropriate documentation. Professional Tools We equip our Service Specialists with professional tools like the Certi-Case containing certified micrometer, glass burette, resistors, and voltage simulator. Brochure Methods of Moisture Content Determination ( ) Karl Fischer "The method at a glance (Leporello ) 10 11

7 Excellence Titrators T50 T70 T90 Titration Automation Rondolino Rondo 12 Rondo 15 Rondo 20 Rondo 30 Rondo 60 Rondo 60 plus LabX Software LabX balance LabX titration LabX connect Good Decisions for Safe Titration Good Good Good Titration Automation Titration Excellence One Click Titration Simple, Efficient and Secure Ask for the following brochures: Titration Excellence One Click Titration : Simple, Efficient and Secure ( ) Titration Automation Fully Automate your Titration Processes for maximum efficiency and security ( ) Fully Automate your Titration Processes for maximum efficiency and security LabX Software LabX Software Complete Overview, Total Control Smart Laboratory Instrument Software ( ) Complete Overview, Total Control Smart Laboratory Instrument Software For more information Mettler-Toledo AG, Analytical CH-8603 Schwerzenbach Switzerland Phone Fax Subject to technical changes 03/2008 Mettler-Toledo AG Printed in Switzerland ME-51724xxx MarCom Analytical