Calibration, Verification, and Certification for Analytical Instruments

Titration, Density and Refractometry, Melting and Dropping Point, UV/Vis Spectrophotometry, pH Meters, Thermal Analysis

Your analytical instruments play a key role in your quality system. How can you ensure that they measure accurately? Reliable measurements help you maintain product quality and save money by avoiding costly mistakes. Additionally, how can you meet all regulatory requirements and adhere to both internal and external standards?

METTLER TOLEDO calibration and verification services document how accurate your measurement equipment is and if it is accurate enough for your specific needs.

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Analytical Instruments Calibration and Verification
Calibration, Verification, and Certification for Analytical Instruments
Compliance with Regulations and Standards
Compliance with Regulations and Standards
Fully Traceable and Audit-Ready Certificates
Fully Traceable and Audit-Ready Certificates
Accurate and Reliable Results
Accurate and Reliable Results
Certified Reference Materials
Certified Reference Materials
Globally Harmonized Procedures
Globally Harmonized Procedures
滴定方法確效指南

滴定方法確效

這份指南舉了幾個常見的滴定應用,來說明滴定方法的確效步驟。其中包含實用的秘訣及建議。

光譜儀校正

白皮書: 紫外線可見光實驗室應該如何進行光譜儀校正?

此白皮書解釋根據最新美國及歐洲藥典與解決方案進行的紫外線可見光光譜儀校正,以確保合規性。

實驗室資料完整性指南

實驗室資料完整性指南

集合有關 ALCOA+ 原則、SOP 指引、資料管理與實用秘訣的知識文件,確保實驗室的資料完整性。

實驗室自動化指南

實驗室自動化指南

使用實驗室自動化提高效率和可再現性。深入瞭解單一和多重樣品自動化解決方案。

熱值

瞭解熱值

本指南介紹了 METTLER TOLEDO 在熔點、沸點、濁點、滴點和軟化點方面的專業知識,統稱為熱值。

符合製藥業對密度與折射率的測量規範

符合密度與折射率相關規範

瞭解如何在製藥產業準確測量密度與折射率,且符合測量規範。

How frequently do I need calibration services?

The calibration interval strongly depends on the individual application, frequency of use, and environmental conditions. Typically, the frequency is determined based on a risk assessment of the entire process where the equipment is used.   

While METTLER TOLEDO provides recommendations, ultimately it is the user's responsibility to determine the frequency of maintenance and calibration required for their process.

Is calibration performed onsite, or are the devices sent to a depot/calibration lab?

Primarily, calibration should be performed onsite to consider performance under actual ambient/user conditions. 

However, for some equipment (e.g.: titration burettes, portable instruments), depot calibration is available. Availability also depends on the local METTLER TOLEDO service setup/infrastructure. 

What is titration calibration?

Titration calibration is basically the verification of the technical specification of a titrator. For example, the burette drive stroke length significantly impacts the dosing accuracy, which is crucial to achieving accurate and reliable titration results. We use a certified micrometer and measure the stroke length at different levels (in accordance with ISO 8655) to ensure dosing accuracy over the entire dispensing range/burette volume. The burette volume is calibrated separately, according to ISO 8655 part 3, to ensure truly interchangeable burettes.

The accuracy of the sensor input is indispensable for proper potential measurements (e.g., mV/pH) to monitor the titration reaction and the correct EP/EQP evaluation. For calibration, we are using certified resistors and digital multimeter to ensure measurements are within specifications.

For the InMotion™ KF Oven Autosampler, the oven temperature accuracy and stability and gas flow rate are calibrated using a certified temperature sensor and gas flow meter.

The certificate includes a clear pass/fail decision based on maximum permissible errors from technical specifications and provides full traceability of all measurement results and tools used for calibration.    

What is the difference between adjustment and calibration for density and refractometry?

The adjustment builds the relationship between the measured signal/value and the result unit. This is the oscillation frequency for density measurements and the critical angle of total reflection for the refractive index, respectively. To be able to measure proper density or refractive index values, the corresponding measurement cells need to be adjusted using known samples/reference standards, i.e., water and/or air.

A calibration is performed using certified reference standards and establishes the difference between the actual measured value and the certified value of the reference standard. If the measured value is within the tolerances, calibration is passed. If the measured value is outside the tolerances, we recommend thoroughly cleaning and drying the measurement cell and then recalibrating, it before doing a re-adjustment of the measuring cell.

Our instruments are delivered with a factory adjustment, except for Excellence and Portable Refractometers.

Can METTLER TOLEDO calibrate my UV/Vis spectrophotometer to comply with both pharmacopeias, Ph. Eur. and USP?

Yes, it’s possible to calibrate the UV/Vis Spectrophotometer to be compliant with both pharmacopeias.

The main difference between USP and Ph. Eur. is related to stray light determination. There are two different procedures for stray light determination, i.e.:

Procedure A: Solution Filter Ratio Method (SFRM)

Procedure B: Specific Wavelength method (SWM)

While USP accepts both procedures, Ph. Eur. only accepts procedure B.

Using the CertiRef EUP enables performance verification and calibration for compliance with both pharmacopeias. For photometric linearity, either LinSet PDC or LinSet Niacin can be used for compliance with USP and Ph. Eur.

Please note that only UV7 Excellence complies with pharmacopeias.

Which standard(s) can I use for dropping point performance verification and calibration/adjustment?

METTLER TOLEDO reference substances, such as benzophenone, vanillin, benzoic acid, and potassium nitrate, provide temperature values that can be used for the temperature calibration of dropping point instruments.

Caffeine and saccharine cannot be used as they do not drop properly.

The basis for comparison is the thermodynamic melting point of the calibration substance that is detailed on the corresponding certificate. However, the dropping point of a reference substance is not equal to the thermodynamic melting point as it refers to the furnace temperature but not the sample temperature. Therefore, the temperature needs to be adjusted using a substance-specific correction factor.

The DP70 and DP90 Excellence instruments include an automatic procedure/method for temperature verification, and correction factors for each reference substance are stored in the instrument. 

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