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Installation and Qualification for Thermal Analysis Instruments
Immediate Deployment Into Routine Operation
Compliance with Regulations and Standards
Evidence That Instrument Is Fit-for-Purpose
Efficient and Safe Operation
Audit-Proof Documentation
The right installation and qualification service depends on the equipment type, your industry, your regulatory environment, and the instrument's applications and use. We provide two levels of installation packages to assist you in establishing a strong foundation for the enduring accuracy, compliance, and reliability of your investment.
Installation

StarterPac

Basic-level, professional installation for immediate deployment and a trustworthy start.

Activities

1
Professional installation
2
Functional checks
3
Basic user familiarization
4
Summary documentation

Suitable for

  • non-regulated industries
Comprehensive qualification

EQPac

The go-to qualification service includes full IQ/OQ, detailed functional testing, calibration and adjustment, and comprehensive documentation for your audit.

Activities

1
Professional installation and qualification (IQ)
2
Operational testing (OQ)
3
Performance verification (OQ)
4
Initial calibration
5
Basic user familiarization
6
Recommendations for PQ and MQ
7
Comprehensive documentation

Suitable for

  • highly regulated industries
Datasheet: Comprehensive Installation / Qualification - Thermal Analysis Service

Datasheet: Comprehensive Installation / Qualification - Thermal Analysis Service

Operational and functional testing procedures are performed and documented on site by an authorized...

Datasheet: Thermal Analysis Calibration Service

Datasheet: Thermal Analysis Calibration Service

Benefit from our unique calibration and adjustment services for your thermal analysis instrumentatio...

Datasheet: ACC Calibration Datasheet for TGA Microbalances

Datasheet: ACC Calibration Datasheet for TGA Microbalances

ACC quantifies the performance of your TGA micro- or ultra-microbalance and determines the measureme...

What is a thermal analysis device Construction Qualification (CQ)?

When the instrument leaves the factory, it is fully calibrated.

For example, for a DSC, it means: 

  • Temperature and heat flow (melting enthalpy) calibration
  • Noise, drift, and artifacts checks
  • Gas flow tests

This process is called Construction Qualification, and the corresponding certificate is included with the shipped instrument.

What is the difference between Installation and, Operational and Performance Qualification (IQ/OQ/PQ) for thermal analysis devices?

The thermal analysis Installation Qualification (IQ) confirms correct delivery and installation. The technical expert verifies that the installation is carried out according to METTLER TOLEDO specifications (complete delivery, suitable environment, software set-up, etc.). 

The Operational Qualification (OQ) checks functionality and performance. The thermal analysis technical expert verifies that the system functions according to METTLER TOLEDO specifications. It means general tests (temperature, drift, noise, artifacts, etc.) and calibration of module-specific parameters depending on the instrument. A clear pass/ fail statement is delivered.

The Performance Qualification (PQ) provides ongoing evidence of fit-for-purpose. The thermal analysis device owner performs tests according to the URS (User Requirement Specifications), and the PQ proves that the system meets those specifications and provides evidence for the audits. 


What are the User Requirement Specifications (URS) and the Design Qualification (DQ) for thermal analysis devices?

The very first step of a fully qualified system is a well-defined user requirement specification, or URS. This is defined by the user and includes the exact requirements of the measurement system to be purchased. The URS is based on measurements that the device will perform, using a named sample substance, and includes the permitted tolerance of the measurements.

For example, for a thermogravimetric analyzer TGA), a URS might detail that the instrument must accurately determine the water content of a certain substance. For the built-in microbalance, specifications could include error of indication and repeatability tests.

The next step is Design Qualification, or DQ. At this stage, the user can consult a METTLER TOLEDO expert and together define a system that meets the requirements of the URS. The DQ defines all equipment and accessories, as well as laboratory requirements such as the number and type of gases to be available.