(*) Availability varies for different Analytical Instruments.
Professional Installation and Qualification for Analytical Instruments
Titration, Density and Refractometry, Melting and Dropping Point, UV/Vis Spectrophotometry, pH Meters, Thermal Analysis
Your analytical instruments play an important role in your production and quality control. How can you make sure you will get excellent performance from day one and beyond? How can you achieve compliance with regulations and efficiency targets?
Installation can be a complex procedure where expert knowledge is required. That's where we come in. Our team of factory-trained technicians has the expertise to install your new equipment correctly and ensure that it performs at its peak. We follow manufacturer specifications, document the procedure for your quality system, and get the job done quickly and efficiently.
Professional Installation and Qualification for Analytical Instruments
Benefits of Analytical Instruments Installation and Qualification
Immediate Deployment into Routine Operation
Compliance with Regulations and Standards
Evidence That Instrument Is Fit-for-Purpose
Efficient and Safe Operation
Audit-Proof Documentation
Installation Services That Cover All Your Needs
The required installation and qualification service depends on the equipment type, your industry, the regulatory environment, and your applications and usage of the instrument. We provide three levels of installation packages (*) to assist you in establishing a strong foundation for the enduring accuracy and reliability of your investment.
Installation
StarterPac
Professional installation, basic functional tests and user familiarization.
Activities
1
Professional installation
2
Functional checks
3
Basic user familiarization
4
Summary documentation
Suitable for
- non-regulated industries
Standard qualification
IPac
Professional installation combined with performance testing and qualification (IQ/OQ).
Activities
1
Professional installation and qualification (IQ)
2
Operational testing (OQ)
3
Performance verification (OQ)
4
Basic user familiarization
5
Recommendations for PQ and MQ
6
Standard documentation
Suitable for
- moderate or self-regulated industries
Comprehensive qualification
EQPac
Professional installation combined with performance testing and comprehensive qualification, including initial calibration.
Activities
1
Professional installation and qualification (IQ)
2
Operational testing (OQ)
3
Performance verification
4
Initial calibration
5
Basic user familiarization
6
Recommendations for PQ and MQ
7
Comprehensive documentation
Suitable for
- highly regulated industries
Why are qualified installations preferred?
By having your analytical instrument installed by manufacturer-trained specialists, you can be confident that the equipment is installed properly and safely. This includes tailored setup to user-specific requirements and environmental conditions.
Operational testing combined with performance verification ensures peak performance from day one.
Furthermore, the basic user familiarization on optimal operation provides increased user confidence, facilitating direct deployment and increased productivity.
The comprehensive documentation meets the requirements of quality systems and enables excellent regulatory compliance.
Installation Qualification (IQ)
The purpose of Installation Qualification is to demonstrate and document:
- The analytical instrument has been received as ordered (completeness)
- Installation and environmental conditions are appropriate
- Registration of exact equipment location
- Identification of all equipment components
- Equipment is correctly installed and powered up successfully
Operational Qualification (OQ)
The purpose of Operational Qualification is to demonstrate and document:
- The analytical instrument is working correctly (functioning and operation) in the selected environment.
- Adherence to technical specifications from the manufacturer
- Performance / measurement verification
- Initial user familiarization
Proved Performance for Accurate Results
Performance verification is an indispensable part of the installation and qualification of an analytical instrument. The adherence to technical and measurement specifications builds the basis to achieve accurate and reliable results.
Quality systems and regulations require frequent performance verification throughout the entire instrument lifecycle.
Titration Performance Verification
For titration, performance verification involves a General System Suitability Test (GSST), which is based on a standard titer determination (General Titration) or a water content determination (Karl Fischer Titration), respectively. Acceptance criteria are in accordance with the OMCL Quality Management Guideline.
Automated UV/Vis Spectrophotometer Performance Verification
Performance verification is crucial to ensure accurate and reliable instrument performance. To accommodate the increasing demand for time-consuming performance verification in regulated laboratories, CertiRef™ and LinSet™ offer a fully automated and secure solution for USP and Ph. Eur. compliant performance verification.
Performance Verification of Melting & Dropping Point Instruments
Performance verification by temperature calibration is the recommended workflow to ensure faultless routine operation of a melting or dropping point instrument and to secure result accuracy and reliability. We provide ready-to-use standard procedures to ensure efficient and error-free performance testing or calibration and adjustment if required.
Mastering Regulatory Compliance from Day One
Regulatory compliance is a key objective for all pharmaceutical manufacturers and their suppliers.
According to GMP, manufacturing processes and analytical methods need to be validated, while at the same time, the equipment used for production and quality control requires qualification.
Our qualification pacs are specifically designed to address today’s demanding regulatory environment, providing an onsite, fully documented, professional installation and qualification to ensure compliance and reliable operation.
While IPac covers a standard qualification, EQPac fulfills the highest demands for regulatory compliance.
Increased Productivity with Basic User Familiarization
User familiarization is key to productivity and efficiency as it reduces the learning curve and enables the users to quickly and easily navigate through analytical instrument operation and application. The user works faster and with confidence, which ultimately leads to greater productivity and efficiency. Furthermore, user familiarization helps reduce errors, improve user satisfaction, and enhance overall user experience. By investing in user training, organizations can improve their bottom line and gain a competitive advantage in today's fast-paced business environment.
Professional Installation and Qualification for pH Meters
pH, conductivity, ion, ORP, and dissolved oxygen
Discover our Professional Installation and Qualification services for pH meters, designed to ensure peak performance and regulatory compliance. Our offerings include:
- Installation Qualification (IQ): Verify proper setup
- Operational Qualification (OQ): Document functionality and user training
- Performance Qualification (PQ): Regular accuracy checks
- Routine Service: Scheduled maintenance and calibration
With our expert support, you can trust your pH meters to operate effectively and meet all necessary standards.
Installation and Qualification for Thermal Analysis Equipment
Differential Scanning Calorimetry (DSC), Thermogravimetry (TGA),
Thermomechanical Analysis (TMA), Dynamic Mechanical Analysis (DMA)
For thermal analysis devices, we provide two levels of installation packages to assist you in establishing a solid foundation for the enduring accuracy, compliance, and reliability of your investment.
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FAQs
Which installation or qualification Pac is suitable for my analytical instrument?
The selection of the appropriate installation or qualification Pac depends on your industry, workplace, application, and regulatory requirements.
The StarterPac offers a professional installation, basic functional tests, and user familiarization, but no qualification, and is suitable for a non-regulated environment. IPac is suitable for moderate or self-regulated industries offering a standard qualification, including performance verification and documentation. The EQPac provides a comprehensive qualification, including performance verification, initial calibration, and substantial documentation, and is suitable for highly regulated industries.
What is covered with basic user familiarization for my analytical instrument?
Basic user familiarization includes an overview of the analytical measurement principle, instrument components and their functionality, setup, configuration, and essential operation techniques. In addition, basic instrument care and awareness of available supporting documentation are covered.
If you require a deeper understanding of your analytical instrument, ask for a customized training to cover your individual needs.
What is meant by performance verification of my analytical instrument?
The performance verification of an analytical instrument comprises the measurement of standard reference samples or certified reference materials (CRMs) to prove that the instrument is able to perform a correct measurement under use condition/environment and within predefined limits/specifications.
For titration, it is a General System Suitability Test (GSST) which is based on a standard titer determination (General Titration) or a water content determination (Karl Fischer Titration), respectively. Acceptance criteria are in accordance with the OMCL Quality Management Guideline.
For density and refractometry, melting and dropping point, and UV/Vis spectrophotometry, the Performance Verification is based on the measurement of certified reference materials to prove that the instrument is working properly within specifications according to international and regional guidelines and regulations, e.g., USP, etc.
Performance Verification is part of the initial Operational Qualification (OQ). The same test can also be used for regular performance verification by the Instrument user to prove consistent and accurate performance throughout its life cycle.