AutoChem Installation, Qualification, Set-up, and Configuration

Chemical Synthesis Reactors, FTIR and Raman Spectrometers, and Particle Size Analyzers

With the combination of installation, qualification, user-specific calibration, training, and documentation, you ensure the highest performance right from the start. Operational and functional testing procedures are performed and documented onsite by an authorized specialist. This includes proven qualification protocols and adequate environmental conditions according to customer requirements. 

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Experience the METTLER TOLEDO Service Difference
Immediate Deployment into Routine Operation
Immediate Deployment into Routine Operation
Compliance with Regulations and Standards
Compliance with Regulations and Standards
Evidence That Instrument Is Fit-for-Purpose
Evidence That Instrument Is Fit-for-Purpose
Efficient and Safe Operation
Efficient and Safe Operation
Audit-Proof Documentation
Audit-Proof Documentation
Dependiendo de su sector, regulación y aplicación, disponemos de tres niveles de paquetes de instalación disponibles para adaptarse a sus necesidades específicas:
Instalación profesional

StarterPac

Instalación profesional de productos y sólida familiarización del usuario en entornos poco regulados o no regulados, como el ámbito académico.

La instalación de StarterPac incluye

1
Instalación experta realizada por un técnico de servicio de METTLER TOLEDO capacitado en fábrica
2
Confirmación básica con lista de verificación funcional
3
Familiarización con el hardware y la operación
4
Calificación de instalación (IQ)

Recomendado para las siguientes industrias

  • Academia
Popular
Cualificación estándar

IPac

Instalación y cualificación operativa, incluyendo el cumplimiento documentado de normas internas y normativas externas.

La instalación y cualificación de IPac incluye

1
Todos los artículos en StarterPac
2
Documentación estándar de cualificación con lista de verificación funcional
3
Calificación Operacional (OQ)
4
Validación y calibración de instrumentos in situ según especificaciones de fabricación (dependiente del producto)

Recomendado para las siguientes industrias

  • Química
  • Farmacéutica (puede requerir EQPac)
  • Laboratorios de pruebas
  • CDMO/CRO
Titulación integral

EQPac

Documentación completa con IQ/OQ ejecutados profesionalmente para aplicaciones con requisitos de calidad más estrictos.

La instalación y cualificación de EQPac incluye

1
Todos los artículos en IPac
2
Validación de software
3
Certificación de material (dependiente del producto)
4
Libro de mantenimiento

Recomendado para las siguientes industrias

  • Farmacéutica (aplicaciones reguladas por la FDA y GMP)

Do I need an AutoChem IPac Standard Qualification for installation?

If your data will be used to make business decisions that will impact your company financially yes, an AutoChem IPac would be the best option. In addition to what is included in the StarterPac, it also includes operational qualification (OQ). The technician performs on-site instrument validation and calibration.

Why are there different AutoChem installation offerings available? Isn’t there only one way to install the equipment?

There are different levels of qualification available for installation based on what is more appropriate for your company and application. If factory inspection is sufficient, like in academia, then the StarterPac with its functional checklist is appropriate and will trigger the start of your warranty period.

If your industry or application typically requires installation and operational qualification, like the pharmaceutical or chemical industries, then an IPac is most appropriate. This service includes on-site instrument validation and performance verification to ensure it still meets specification after installation at your site. For production or manufacturing applications with stricter quality requirements (FDA, GMP, and European Pharmacopeia), the EQPac is the most appropriate. 

Do I need an AutoChem EQPac?

If the AutoChem instrument you’ve purchased will be used in a regulated environment (e.g. GMP), then the best option will be an EQPac. This service includes software validation, material certification, and a maintenance logbook, in addition to the Standard Qualification activities. 

Is there an AutoChem installation checklist available prior to the technician coming onsite?

Yes, you will be sent a checklist after your order is complete. This will ensure all utilities needed are available during installation.

What is the warranty period for my AutoChem instrument?

We warrant our AutoChem products against defects in material and workmanship for 12 months from the date of installation or 18 months from the date of shipment to the buyer's destination, whichever is earlier, so long as all necessary maintenance and/or installation has been performed on the products and said products have been used in accordance with the published specifications. Should any products contain such defects, we will repair the product at no additional charge. 

What repairs are not included during the AutoChem warranty period?

A repair will not be approved where METTLER TOLEDO equipment has been subjected to accident, alteration, misuse, abuse, or failure by the buyer to ensure proper storage, operation, maintenance, installation, and/or servicing by personnel METTLER TOLEDO does not authorize or due to environmental or operational conditions.

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