Systemically preparing and setting up your measuring device is vital for ensuring smooth, sustained operation that delivers results on time. Unpleasant surprises caused, for example, by an inadequate infrastructure, missing certification or a lack of knowledge can be effectively prevented.
Our professional advisory service ensures that all necessary framework conditions are created for your devices and software to operate continuously and reliably. We will discuss the following key points with you:
- Future location of the device with regard to accessibility, supply lines and ambient conditions
- Legal requirements, such as standards, national laws and safety considerations
- Risk assessment for defining the required and available services
- Setting up your individual servicing profile Benefits
- Optimum conditions for successful start-up
- Individual servicing concept to prevent unplanned output losses
Installation and commissioning Installation and commissioning are generally done one after the other or, depending on the device group and conditions for acceptance, there may be a delay between them.
Professional installation is the basis for successful commissioning and should be done by a service provider with the appropriate qualifications. Installation involves physically positioning the device or system and the laying the power and data cables. At the same time, the device specifications, scope of delivery and documentation are also checked.
- Confirmation that the device is complete and meets the specifications
- Certainty that commissioning can take place immediately
Commissioning takes place according to a rigidly defined plan. This includes, for example:
- setting the parameters of the device
- adapting the device to the relevant ambient conditions and processes
- calibrating or making adjustments
- a full functional test - training the operating personnel
- if applicable, carrying out a conformity assessment in accordance with applicable legal requirements
- Commissioning is done as per your requirements
- The device can be used immediately
- All legal requirements are satisfied and documented
- Compliance with quality standards is ensured and documented
Quick availability of spare parts is essential for preventing device and system failure and to ensure that function and output are restored as fast as possible. Depending on the risk assessment, essential spare parts should be available on-site or close to the device or system. In addition to adhoc spare parts, Minebea Intec also offers tailored spare part packages.
Starter Kit: The Starter Kit is ideal for new products. The kit includes the most important spare and wearing parts, giving you advanced protection right from the start.
Life Cycle Kit: The Life Cycle Kit is designed for maintenance and replacements after months or years of operation, thus optimising the function of your devices.
Emergency Kit: This kit contains crucial spare parts. Having parts available as a preventive measure is essential for reducing downtime as much as possible, especially in sensitive areas of the system.
Total Care Kit: The all-round carefree package. In addition to the standard spare and wearing parts, this kit also contains components that fail less frequently, meaning you are covered for more or less all eventualities
The spare parts are available when you need them
Production loss is reduced to the minimum
Legal verification and accreditation
Legal requirements and normative regulations are part of everyday life in the measurement technology industry. These challenges must be dealt with professionally, especially for clients in regulated environments and anywhere where consumer protection takes highest priority.
Minebea Intec helps you to satisfy legal requirements and follow GxP guidelines – be it implementing national and international calibration requirements or conducting reliable and accredited device calibration.
- Reliable and compliant measuring technology
- Adherence to applicable legal calibration requirements
- Consistent implementation of quality management system requirements according to DIN ISO9001
Test equipment is an important element of a quality management system. It is used as a reference for validating quality standards and should be selected carefully.
Minebea Intec offers you the right test equipment for weighing technology and foreign body detection applications in compliance with the binding standards and regulations (e.g. DIN EN ISO/IEC 17025, HACCP, IFS, BRC).
- Audit-proof thanks to compliance with binding standards and regulations
- Greatest possible process reliability thanks to reliable test equipment
- Consistently high and reliable accuracy for your measuring devices
FAT, SAT, IQ/OQ
Measuring devices, systems and bits of equipment that are used in regulated environments (GMP), in particular, are subject to special test requirements. The tests are carried out within the scope of a documented device qualification procedure (IQ/OQ).
Similar test scenarios, such as FAT and SAT, are typical in non-regulated environments. A combination of the different test scenarios is also possible in regulated environments. However, it should be noted that, although FAT and SAT can supplement a device qualification procedure, they cannot under any circumstances replace it.
Minebea Intec offers the relevant services for device qualification and acceptance procedures. In addition to operational implementation by our service experts, these also include test plans for proving device suitability.
- Documented qualification of your devices in line with directives and standards
- The risk-based proof of suitability increases security against deviations
FAT – Factory Acceptance Test
Device, system or software acceptance procedures conducted at the manufacturer’s premises ensure that the scope of performance defined in the specifications has been demonstrably fulfilled. Factory acceptance includes checking basic device specifications such as dimensions or material properties as well as functions of the mechanical and electrical systems.
SAT – Site Acceptance Test
Acceptance procedures conducted on-site at the client’s premises are used to prove that assembly has been carried out properly and that the performance and functionality of the device is fully in line with specifications. As a general rule, additional performance tests are carried out with products under production conditions that are as realistic as possible.
IQ – Installation Qualification
Installation qualification proves that the systems and devices used have been installed properly. Within the context of process validation, this qualification procedure is therefore a deciding factor for product quality and product reliability.
The aim of installation qualification is to provide documented proof that the device has been installed properly in regulated environments (e.g. GLP, GMP) and that the requirements set by the operator with regard to scope of delivery, documentation, technology and conformity have been met.
OQ – Operational Qualification
Operational qualification is used to prove that the technologies used for production and quality control serve their purpose. In other words, that the device functions as intended in regulated environments (e.g. GLP, GMP) and that the specified requirements and limit values are adhered to in the entire operating range.
Supreme measurement accuracy and thus manufacturing quality can only be guaranteed if the device has been subjected to a standardised calibration procedure (comparative measurement with a traceable reference value). Minebea Intec offers device calibration services incl. certificates, etc., in accordance with DIN EN ISO/ IEC 17025. The calibration values for the measuring device are recorded, documented and readjusted in the event of deviations using suitable reference values (e.g. certified calibration weights). In addition, Minebea Intec offers calibration according to European Pharmacopeia (Ph. Eur.) 2.1.7 and United States Pharmacopeia (USP) Chapter 41 for the manufacture of medicinal products and excipients for drug formulation.
- Reliable and compliant measuring technology
- Risks minimised thanks to regular calibration
- Consistent implementation of quality management system requirements (according to DIN 9001)
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