Frequently Asked Questions
Please contact Sartorius Service. Use our contact form and provide us with as many details as possible so that we can help you quickly. The serial number, device category and device type are of particular importance. Once we receive your message, we will contact you as soon as possible to discuss the next steps.
The best way is to use our Contact Form. Our Sartorius staff will be happy to advise you on whether your equipment really needs to be repaired or was just incorrectly operated or whether one single spare part has to be replaced.
After troubleshooting to clarify the items above, you will receive a Return Form from us. Please be sure to provide all the information requested. Next, simply send in this form along with your equipment back to us. We will then email you a cost estimate or a quote for a comparable new instrument if it will not be worth the expense for you to have it repaired.
Please first check whether you can order the spare part in our e-shop (login required). If not, please use our contact form. Select the area "I need a replacement part" and provide all the necessary information. We will then get in touch with you.
Please contact us in advance using our contact form. Our Sartorius Service staff will be happy to advise you as to whether repairs are needed; malfunctions are often merely operator errors or a replacement part is sufficient to fix any problems.
After clarifying these points, you will receive a return form. Please provide all of the necessary particulars and send it back with the device. We will then send you a cost estimate.
Our service technicians will get in touch with you a few days beforehand to arrange a suitable appointment for you.
Accessories and consumables can be found on the respective Sartorius product website.
I have a maintenance contract. How do I know when the next service interval will take place and who will contact me?
The service interval is defined in your contract. Before your next maintenance date, we will first contact you in writing and then call you to schedule an appointment.
Qualification (SAT and IQ|OQ)
Qualifications serve as proof of suitability of your equipment. Device qualification involves checking whether the full scope of delivery is included and whether the equipment meets all the necessary requirements and specifications. The entire process is carefully documented. After the device qualification has been performed, the next step, in many cases, is process validation.
A validation furnishes proof that the entire process leads to the expected results and meets predefined specifications and quality characteristics. A process validation thus also always includes a system and equipment qualification. In the bioprocessing industry, but also often in the laboratory environment, both qualification and validation must be carried out in accordance with the Good Manufacturing Practice guidelines before starting production or research.
The qualification and validation form the basis for drug safety and are a prerequisite for all work in a GMP regulated environment.
What does the risk-based approach stand for with respect to the qualification of laboratory equipment?
In August 2012, the US Food and Drug Administration (FDA) introduced the risk-based approach. The aim of the approach is to focus on critical areas during pharmaceutical quality control. All quality assurance measures should therefore be justified from the risk analysis.
It makes sense to follow this approach in the qualification of laboratory equipment. During a risk-based qualification, not every function is checked, but rather only those that are risky and can affect quality. Inspection is therefore faster and, above all, more efficient.
The calibration interval will depend on how often you use the device and the impact it has on the entire research process. Equipment with a higher quality risk should be calibrated more frequently than devices that have a lesser impact. The degree of utilization and the criticality of the process parameters are key in the bioprocessing environment as well.
The DIN EN ISO/IEC 17025 is the global standard used to corroborate the competence and accuracy of a calibration laboratory. Sartorius can issue accredited calibration certificates according to DIN EN ISO/IEC 17025 for different measured variables. For you, this means: Greater acceptance of your products and results as well as international comparability and recognition of your certificates.