Titra

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Safe TitrationMinimized Risk

Reduced Efforts

Successful Audits

Guaranteed QualitySafe Titration in the Pharmaceutical Industry

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Evaluation Installation

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Safe

Titr

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n Titration without SurprisesMinimize Risks

Good Titration PracticeTM

InstallationAccording 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 cus-tomers in performing the qualifica-

EvaluationThe selection of the correct analysis instrument does not only encom-pass the knowledge of your current needs, but also your future require-ments.Modular titration systems such as the Excellence Series offer solutions for the security of your investment.Safe titration encompasses the entire life cycle 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.

RoutineWell-informed users and regularly maintained titrators avoid measur-ing 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 dis-posal 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.

tion by providing the instrument qualification dedicated documenta-tion and offering the qualification service.

Professional training gives you in addition the required security and expertise in handling the titrator.

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DL31/DL38Equipment Qualific

ation Package

Titration ExcellenceEQPac

Manufacturer: METTLER TOLEDO

Instrument type:

Instrument internal number:

Instrument serial number:

www.mt.com/pharmatitrator

Eval

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n Select with ForesightProtecting your Investment

Documented requirements secure the right choiceIn 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.

Typical requirements of the pharmaceutical industry cover the areas: Regulatory compliance Productivity increase/cost reduction Data management Accuracy/reliability of results Qualification/auditpreparation

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.

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.

The Production Technician has just afew titration tasks. His screen shows onebutton 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.

Each user has his own Home screenEach 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.

Comprehensive assistance for the selection of the right titrator and the correct methodDetailed product documentation, text books and comprehensive ap-plication databases as well as the technically trained sales staff of METTLER TOLEDO help you evalu-ate the right titrator for your needs. We pay particular attention to the specific requirements of the differ-ent users. Since the users can change over time, a future-oriented solution is always a concern for us.

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www.mt.com/one-click-titration

One Click™ TitrationSimple – Efficient and Secure

Tailoredexactlytofitperfectly

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 mostdirectrouteischaracterizedbysimplicity,efficiency,andsecurity

Plug & Play Sensorskept under controlThe instruments in the TitrationExcellence line automatically rec-ognize 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.

The Sensor Chip saves all relevantsensor data.

The burette data is automaticallyread by the RFID sensor.

Intelligent burettes guaranteesecurityIs the correct titrant in the burette? Is the concentration right? Has the titer expired? On which drive is it installed? The Titration Excellencesystem automatically verifies all these parameters when an analysis is started. Simply mount the buretteand it does the work for you.

Completeefficiency– One Click™ TitrationThe Titration Excellence line en-sures you get your results easily and quickly. The Short Cuts, which can be set up specifically for each user, are extremely helpful. Wheth-er 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.

Start your analyses directly using ShortCuts (from the Home Screen).Your titrator can simultaneously run up to eight different tasks.

Maximum security throughflexible Titration Excellence instruments are equipped with a comprehensive user management system that al-lows 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 user-defined settings appear such as screen settings or the language the user requires.

The modular titration platform is a sound investmentThe 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 intel-ligent accessories for automatic sample preparation, with the clever CoverUp™ lid handling device to avoid contamination and unpleas-ant odors, with a second tower to separate different determinations such as conductivity from pH mea-surement, with kits for COD or KF titrations, and so on – the system grows with your requirements.

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 pass-word protected user login, digital signature for critical manipulations and recording of every action in the audit trail.

LabX offers control charts and in-dividual search filters, quick and comprehensive method develop-ment 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 connec-tion.

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DL31/DL38Equipment Qualification PackageTitration ExcellenceEQPac

Manufacturer: METTLER TOLEDOInstrument type:

Instrument internal number:

Instrument serial number:

Correct Measurements from the StartKnowledge as a Tool

Savecosts–increaseexpertise

Professionalstart-up,qualificationandcompletedocumentationguaranteetheadherencetoyourprocessrequirementsstartingfromfirsttitration.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.Youprofitfromourexperienceandminimizerisksfromthebeginning.

Increased productivity and minimized risks from the startMETTLER TOLEDO’s qualification solutions for titra-tors 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 ben-efits: No time wasted – a quick installation and qualifica-tion allows you to immediately start working with the titrator.

Increased productivity – users receive product famil-iarization to ensure productive processes.

Compliance – limited risk of non-compliance during FDA audits and other quality management system assessments.

Safe HandlingProfessional 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.

LabX Software Validation

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.

EquipmentQualificationProfessional start-up and qualification using the METTLER TOLEDO Equip-ment Qualification Package (EQPac) is the first important step for adher-ence to the process requirements. It is also the beginning of complete traceability without any gaps.

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Innovative Services for Continuous Correct Titration MeasurementsEach 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 transferUse the many years of METTLER TOLEDO know-how, which is avail-able to you in form of a compre-hensive application database on

the internet or as reference literature (see table).Or refresh your knowledge in daily titration in one of the offered cus-tomer 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 seminarsA 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.

Well Maintained Titratorto Guarantee Accurate ResultsBecause 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

Initial testing/calibrationFunction of titrator componentssuch as stopcock, burette and elec-trode input are checked.

Cleaning and adjustingThe instrument is disassembled and PC-boards, burette,stopcock drives and gears are cleaned and adjusted.

Final testing/calibrationElectrode voltage is checked along with stirrer, burette, tubing and RS232 output.

DocumentationThe titrator service is recorded in the appropriate documentation.

Professional ToolsWe equip our Service Specialists with professional tools like the Certi-Case containing certified micro- meter, glass burette, resistors, and voltage simulator.

Maintenance and calibration process

hidden costs are downtime prod-uct nonconformance, or measure-ment inaccuracies. When select-ing a service solution, the focus should be to minimize the total cost of ownership and increase the ef-fectiveness of your manufacturing processes.

Knowledgeasatool–usefulknow-howprovidedtoyoubyMETTLER TOLEDOMore than 400 ready-to-use titration applications on: www.mt.com/titration_applications

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Applications Brochure 14: “Good Laboratory Practice in the Titration Lab” (51724908)

Applications Brochure 16: “Validation of Titration Methods” (51724912)

Applications Brochure 15: ”Guidelines for Result Check, Method Validation and Instrument Certification“ (51724910)

Applications Brochure 25: “Applications in the Pharmaceutical Industry” (51710071)

Applications Brochure 8 + 9: “Standardization of titrations” (51724650, 51724652)

Brochure „Methods of Moisture Content Determination“ (11795011)

Karl Fischer "The method at a glance” (Leporello 724572)

www.mt.com/pharmatitrator

Evaluation Installation

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Evaluation Installation

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Evaluation Installation

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Good Decisionsfor Safe Titration

Good Evaluation

Good Installation

Good Routine

Ask for the following brochures:

Titration ExcellenceOne Click Titration™: Simple, Efficient and Secure (51724478)

Titration AutomationFully Automate your Titration Processesfor maximum efficiency and security(51724170)

LabX SoftwareComplete Overview, Total ControlSmart Laboratory Instrument Software (51724345)

Mettler-Toledo AG, Analytical CH-8603 SchwerzenbachSwitzerlandPhone +41 44 806 77 11Fax +41 44 806 73 50

Subject to technical changes© 03/2008 Mettler-Toledo AG Printed in Switzerland ME-51724xxxMarCom Analytical

For more information

Titration AutomationRondolino

Rondo 12

Rondo 15

Rondo 20

Rondo 30

Rondo 60

Rondo 60 plus

Fully Automate your Titration Processesfor maximum efficiency and security

Titra

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Auto

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Titra

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Exce

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One Click Titration™Simple, Efficient and Secure

Excellence TitratorsT50

T70

T90

LabX SoftwareLabX balance

LabX titration

LabX connect

Complete Overview, Total ControlSmart Laboratory Instrument Software

LabX

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